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Usare le linee guida sull'HFOT:

la terapia giusta, per il paziente giusto, al momento giusto?

Webinar n. 1

Domande e risposte – Webinar n. 1

Al momento non sono noti protocolli per i casi di intervento cardiochirurgico finalizzato alla correzione di difetti congeniti.

Non esiste un protocollo ufficiale per lo svezzamento (vedere il webinar successivo, tenuto a febbraio 2024, sull'ottimizzazione delle impostazioni della HFOT).

I dati confermano in modo chiaro i vantaggi della CPAP, tuttavia la letteratura disponibile sull'HFNO non è sufficiente per trarre conclusioni.

(a) Per i pazienti ad alto rischio/con obesità, specialmente dopo chirurgia toracica e addominale. Se sono presenti secrezioni, è opportuno valutare anche l'ENT. (b) Nel caso della chirurgia gastrica, utilizzando la NIV potrebbe emergere un problema di pressione sulle suture chirurgiche. (c)  Per i pazienti con insufficienza cardiaca in cui la HFNO non ha avuto esito positivo. È anche possibile alternare HFNO e NIV. 

Prevenzione: l'HFNC è una buona scelta per migliorare il comfort del paziente ed eventualmente per ridurre la durata dei ricoveri.   Trattamento: non è chiaro (non sono stati studiati abbastanza pazienti). La NIV ha alcuni benefici ma non abbiamo dati testa a testa sufficienti per trarre conclusioni.

Esistono tre articoli che dimostrano la costo-efficacia dell'HFNC. Naturalmente non è opportuno utilizzarla in modo indiscriminato.  Per quanto riguarda i pazienti pediatrici, esistono anche pubblicazioni che giustificano l'utilizzo dell'HFNOin caso di bronchiolite: Buendía JA, Acuña-Cordero R, Rodriguez-Martinez CE. The cost-utility of early use of high-flow nasal cannula in bronchiolitis. Health Econ Rev. 2021;11(1):41. Published 2021 Oct 28. doi:10.1186/s13561-021-00339-71​, Buendía JA, Acuña-Cordero R, Rodriguez-Martinez CE. Budget impact analysis of high-flow nasal cannula for infant bronchiolitis: the Colombian National Health System perspective. Curr Med Res Opin. 2021;37(9):1627-1632. doi:10.1080/03007995.2021.19433422​, Heikkilä P, Forma L, Korppi M. High-flow oxygen therapy is more cost-effective for bronchiolitis than standard treatment-A decision-tree analysis. Pediatr Pulmonol. 2016;51(12):1393-1402. doi:10.1002/ppul.234673

Esistono anche alcuni lavori abbastanza convincenti sul rapporto costo/utilità dell'utilizzo dell'HFNO in caso di BPCO in contesto domiciliare: Sørensen SS, Storgaard LH, Weinreich UM. Cost-Effectiveness of Domiciliary High Flow Nasal Cannula Treatment in COPD Patients with Chronic Respiratory Failure. Clinicoecon Outcomes Res. 2021;13:553-564. Published 2021 Jun 18. doi:10.2147/CEOR.S3125234​.

Controindicazioni: paziente non sveglio; mancanza di operatori che possano esaminare/monitorare il paziente (niente allarmi).

Prevalentemente il ritardo nell'intubazione; esiste anche la possibilità di P-SILI (danno polmonare autoindotto, Patient Self Inflicted Lung Injury).

Assolutamente no. Il vantaggio dell'HFO è dato dai flussi elevati. Per questo motivo, se non è presente distress respiratorio (ovvero flussi ridotti) e un arricchimento che permetta di arrivare a una FiO2 pari a 0,5-0,6 è sufficiente, non ve n'è alcun bisogno.

Non abbiamo a disposizione RCT ma sono già disponibili diversi studi interessanti:

COVID-ICU group, for the REVA network, COVID-ICU investigators. Benefits and risks of noninvasive oxygenation strategy in COVID-19: a multicenter, prospective cohort study (COVID-ICU) in 137 hospitals. Crit Care. 2021;25(1):421. Published 2021 Dec 8. doi:10.1186/s13054-021-03784-25: “In patients with COVID-19, HFNC was associated with a reduction in oxygenation failure without improvement in 90-day mortality, whereas NIV was associated with a higher mortality in these patients. “

Ranieri VM, Tonetti T, Navalesi P, et al. High-Flow Nasal Oxygen for Severe Hypoxemia: Oxygenation Response and Outcome in Patients with COVID-19. Am J Respir Crit Care Med. 2022;205(4):431-439. doi:10.1164/rccm.202109-2163OC6: “We analyzed 184 and 131 patients receiving HFNO or NIV, respectively. 112 HFNO, and 69 NIV patients transitioned to IMV. 104 (92.9%) HFNO patients and 66 (95.7%) NIV patients continued to have PaO2/FiO2 ≤300 under IMV…. Overall mortality was 19.0% (35/184) and 24.4% (32/131) for HFNO and NIV, respectively (p=0.2479).”

Perkins GD, Ji C, Connolly BA, et al. Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial. JAMA. 2022;327(6):546-558. doi:10.1001/jama.2022.00287​: “Among patients with acute hypoxemic respiratory failure due to COVID-19, an initial strategy of CPAP significantly reduced the risk of tracheal intubation or mortality compared with conventional oxygen therapy, but there was no significant difference between an initial strategy of HFNO compared with conventional oxygen therapy. The study may have been underpowered for the comparison of HFNO vs conventional oxygen therapy.”
Questa opzione può essere migliore di un'intubazione immediata in questi pazienti.

Assolutamente sì, sebbene i risultati disponibili in letteratura non siano ancora sufficientemente solidi. Non abbiamo a disposizione RCT ma sono già disponibili diversi studi interessanti (vedere la risposta alla domanda precedente).

Sì, noi utilizziamo un connettore specifico per tracheostomia, esclusivamente in aree monitorate. Non per i pazienti che necessitano di una broncoaspirazione 2 o più volte durante ciascun turno del personale infermieristico (ovvero due volte in 8 ore).

Al posto della terapia con ossigeno convenzionale e prima della NIV per tutti i pazienti eccetto quelli con insufficienza cardiaca.

È possibile che in futuro avremo a disposizione metodi per identificare questi pazienti sulla base delle distribuzioni di areazione, mediante TC e lavoro respiratorio, mediante EIT. Ma non ne siamo ancora capaci.

Il casco costituisce l'interfaccia, non la modalità di ventilazione. L'uso di un'interfaccia a casco richiede esperienza. Noi la utilizziamo per i pazienti in grado di cooperare e la alterniamo all'HFNO poiché limita le possibilità di comunicazione e alimentazione del paziente.  

In termini di modalità, la BiPAP è sicuramente l'opzione di prima linea solo in caso di edema polmonare (con insufficienza cardiaca). Un articolo interessante sul confronto tra terapia con casco e HFNO in caso di insufficienza cardiaca (studio monocentrico condotto su circa 200 pazienti): Osman A, Via G, Sallehuddin RM, et al. Helmet continuous positive airway pressure vs. high flow nasal cannula oxygen in acute cardiogenic pulmonary oedema: a randomized controlled trial. Eur Heart J Acute Cardiovasc Care. 2021;10(10):1103-1111. doi:10.1093/ehjacc/zuab0788

In caso di COVID, su 110 pazienti: Grieco DL, Menga LS, Cesarano M, et al. Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial. JAMA. 2021;325(17):1731-1743. doi:10.1001/jama.2021.46829

Tra i pazienti con COVID-19 e ipossiemia da moderata a grave, non sono state registrate differenze significative tra il trattamento mediante ventilazione non invasiva con casco e la terapia con ossigeno ad alto flusso per via nasale per quanto concerne il numero di giorni, calcolato su un arco temporale di 28 giorni complessivi, in cui il paziente non necessitava di supporto respiratorio.

Alterniamo i trattamenti in base alla tolleranza e alla risposta dei pazienti.

Sicuramente BiPAP.

Il problema è dato dal fatto che i tempi medi di apnea emersi negli studi coinvolti nelle metanalisi sono <2 minuti e, nei pazienti in condizioni critiche, addirittura ≮1 minuto. Inoltre, la maggior parte dei pazienti coinvolti in questi studi non aveva ipossia grave, non abbiamo dati sulle eventuali intubazioni difficili e non abbiamo dati sufficienti sull'eventuale obesità (un solo studio) né sulla gravidanza. Complessivamente concordo quindi con l'impressione descritta dal collega e confermo che, nel nostro reparto di terapia intensiva, ricorriamo a questa opzione durante l'intubazione dei pazienti con ipossiemia.

Può verificarsi P-SILI anche con l'HFNO, ma si tratta di un aspetto difficile da misurare in ambito clinico. Abbiamo evidenze dirette di questo fenomeno solo in casi relativi a pazienti neonatali con baro-/volutrauma, ma dobbiamo ipotizzare che il fenomeno sia possibile anche negli adulti.

Almeno 30 litri al minuto (vedere il webinar successivo, tenuto a febbraio 2024, sull'ottimizzazione delle impostazioni per l'HFOT).

Esclusione di responsabilità

I contenuti riportati in questa pagina sono esclusivamente a fini informative e non devono essere intesi come una risorsa che sostituisce un'adeguata formazione professionale o le linee guida standard della propria struttura ospedaliera. Le risposte alle domande presenti in questa pagina sono state preparate dai relatori dei singoli webinar; qualsiasi raccomandazione qui riportata relativa alla pratica clinica o all'utilizzo di prodotti, tecnologie o trattamenti specifici rappresenta esclusivamente l'opinione personale del relatore e non può essere ritenuta una raccomandazione ufficiale da parte di Hamilton Medical AG. Hamilton Medical AG non offre alcuna garanzia per quanto riguarda le informazioni contenute in questa pagina e il lettore che faccia affidamento su qualsiasi parte di queste informazioni lo fa esclusivamente a proprio rischio e pericolo.

Bibliografia

  1. 1. Buendía JA, Acuña-Cordero R, Rodriguez-Martinez CE. The cost-utility of early use of high-flow nasal cannula in bronchiolitis. Health Econ Rev. 2021;11(1):41. Published 2021 Oct 28. doi:10.1186/s13561-021-00339-7
  2. 2. Buendía JA, Acuña-Cordero R, Rodriguez-Martinez CE. Budget impact analysis of high-flow nasal cannula for infant bronchiolitis: the Colombian National Health System perspective. Curr Med Res Opin. 2021;37(9):1627-1632. doi:10.1080/03007995.2021.1943342
  3. 3. Heikkilä P, Forma L, Korppi M. High-flow oxygen therapy is more cost-effective for bronchiolitis than standard treatment-A decision-tree analysis. Pediatr Pulmonol. 2016;51(12):1393-1402. doi:10.1002/ppul.23467
  4. 4. Sørensen SS, Storgaard LH, Weinreich UM. Cost-Effectiveness of Domiciliary High Flow Nasal Cannula Treatment in COPD Patients with Chronic Respiratory Failure. Clinicoecon Outcomes Res. 2021;13:553-564. Published 2021 Jun 18. doi:10.2147/CEOR.S312523
  5. 5. COVID-ICU group, for the REVA network, COVID-ICU investigators. Benefits and risks of noninvasive oxygenation strategy in COVID-19: a multicenter, prospective cohort study (COVID-ICU) in 137 hospitals. Crit Care. 2021;25(1):421. Published 2021 Dec 8. doi:10.1186/s13054-021-03784-2

 

  1. 6. Ranieri VM, Tonetti T, Navalesi P, et al. High-Flow Nasal Oxygen for Severe Hypoxemia: Oxygenation Response and Outcome in Patients with COVID-19. Am J Respir Crit Care Med. 2022;205(4):431-439. doi:10.1164/rccm.202109-2163OC
  2. 7. Perkins GD, Ji C, Connolly BA, et al. Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial. JAMA. 2022;327(6):546-558. doi:10.1001/jama.2022.0028
  3. 8. Osman A, Via G, Sallehuddin RM, et al. Helmet continuous positive airway pressure vs. high flow nasal cannula oxygen in acute cardiogenic pulmonary oedema: a randomized controlled trial. Eur Heart J Acute Cardiovasc Care. 2021;10(10):1103-1111. doi:10.1093/ehjacc/zuab078
  4. 9. Grieco DL, Menga LS, Cesarano M, et al. Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial. JAMA. 2021;325(17):1731-1743. doi:10.1001/jama.2021.4682

Note

 

The cost-utility of early use of high-flow nasal cannula in bronchiolitis.

Buendía JA, Acuña-Cordero R, Rodriguez-Martinez CE. The cost-utility of early use of high-flow nasal cannula in bronchiolitis. Health Econ Rev. 2021;11(1):41. Published 2021 Oct 28. doi:10.1186/s13561-021-00339-7



BACKGROUND

High-flow nasal cannula (HFNC) oxygen is a non-invasive ventilation system that was introduced as an alternative to CPAP (continuous positive airway pressure), with a marked increase in its use in pediatric care settings. This study aimed to evaluate the cost-effectiveness of early use of HFNC compared to oxygen by nasal cannula in an infant with bronchiolitis in the emergency setting.

METHODS

A decision tree model was used to estimate the cost-effectiveness of HFNC compared with oxygen by nasal cannula (control strategy) in an infant with bronchiolitis in the emergency setting. Cost data were obtained from a retrospective study on bronchiolitis from tertiary centers in Rionegro, Colombia, while utilities were collected from the literature.

RESULTS

The QALYs per patient calculated in the base-case model were 0.9141 (95% CI 0.913-0.915) in the HFNC and 0.9105 (95% CI 0.910-0.911) in control group. The cost per patient was US$368 (95% CI US$ 323-411) in HFNC and US$441 (95% CI US$ 384-498) per patient in the control group.

CONCLUSIONS

HFNC was cost-effective HFNC compared to oxygen by nasal cannula in an infant with bronchiolitis in the emergency setting. The use of this technology in emergency settings will allow a more efficient use of resources, especially in low-resource countries with high prevalence of bronchiolitis .

Budget impact analysis of high-flow nasal cannula for infant bronchiolitis: the Colombian National Health System perspective.

Buendía JA, Acuña-Cordero R, Rodriguez-Martinez CE. Budget impact analysis of high-flow nasal cannula for infant bronchiolitis: the Colombian National Health System perspective. Curr Med Res Opin. 2021;37(9):1627-1632. doi:10.1080/03007995.2021.1943342



BACKGROUND

High-flow nasal cannula is a non-invasive ventilation system that was introduced as an alternative to continuous positive airway pressure), with a marked increase in its use in pediatric care settings. However, the expected budget impact of this intervention has not been explicitly estimated. This study aimed to evaluate the budget impact of the high-flow nasal cannula for acute bronchiolitis in Colombia.

METHODS

A budget impact analysis was performed to evaluate the potential financial impact deriving from high-flow nasal cannula during 2020. The analysis considered a 5-year time horizon and Colombian National Health System perspective. The incremental budget impact was calculated by subtracting the cost of the new treatment, in which a high-flow nasal cannula is reimbursed, from the cost of the conventional treatment without a high-flow nasal cannula (supplemental oxygen through a nasal cannula up to a maximum of 2 liters per minute). Univariate one-way sensitivity analyses were performed.

RESULTS

In the base-case analysis the 5-year costs associated with high-flow nasal cannula and no- high-flow nasal cannula were estimated to be US$159,585,618 and US$172,751,689 respectively, indicating savings for Colombian National Health equal to US$13,166,071 if the high-flow nasal cannula is adopted for the routine management of patients with acute bronchiolitis. This result was robust in univariate sensitivity one-way analysis.

CONCLUSION

High-flow nasal cannula was cost-saving in emergency settings for treating infants with acute bronchiolitis. This evidence can be used by decision-makers in our country to improve clinical practice guidelines and should be replicated to validate their results in other middle-income countries.

High-flow oxygen therapy is more cost-effective for bronchiolitis than standard treatment-A decision-tree analysis.

Heikkilä P, Forma L, Korppi M. High-flow oxygen therapy is more cost-effective for bronchiolitis than standard treatment-A decision-tree analysis. Pediatr Pulmonol. 2016;51(12):1393-1402. doi:10.1002/ppul.23467

We evaluated the cost-effectiveness of high-flow nasal cannula (HFNC) to provide additional oxygen for infants with bronchiolitis, compared to standard low-flow therapy. The cost-effectiveness was evaluated by decision analyses, using decision tree modeling, and was based on real costs from our recently published retrospective case-control study. The data on the effectiveness of HFNC treatment were collected from earlier published retrospective studies, using admission rates to pediatric intensive care units (PICU). The analyses in the study showed that the expected treatment costs of each episode of infant bronchiolitis varied between €1,312-2,644 ($1,786-3,600) in the HFNC group and €1,598-3,764 ($2,175-5,125) in the standard treatment group. The PICU admission rates and consequential costs were lower for HFNC than for standard treatment. HFNC treatment proved more cost-effective than standard treatment in all the baseline analyses and was also more cost-effective in the sensitivity analyses, except for in the worst-case scenario analysis. In conclusion, our modeling demonstrated that HFNC was strongly cost-effective for infant bronchiolitis, compared to standard treatment because it was both more effective and less expensive. Thus, if children hospitalized for bronchiolitis need oxygen, it should be delivered as HFNC treatment. Pediatr Pulmonol. 2016;51:1393-1402. © 2016 Wiley Periodicals, Inc.

Cost-Effectiveness of Domiciliary High Flow Nasal Cannula Treatment in COPD Patients with Chronic Respiratory Failure.

Sørensen SS, Storgaard LH, Weinreich UM. Cost-Effectiveness of Domiciliary High Flow Nasal Cannula Treatment in COPD Patients with Chronic Respiratory Failure. Clinicoecon Outcomes Res. 2021;13:553-564. Published 2021 Jun 18. doi:10.2147/CEOR.S312523



PURPOSE

To evaluate the cost-effectiveness of long-term domiciliary high flow nasal cannula (HFNC) treatment in COPD patients with chronic respiratory failure.

PATIENTS AND METHODS

A cohort of 200 COPD patients were equally randomized into usual care ± HFNC and followed for 12 months. The outcome of the analysis was the incremental cost per quality-adjusted life-year (QALY) gained, and the analysis was conducted from a healthcare sector perspective. Data on the patients' health-related quality of life (HRQoL), gathered throughout the trial using the St. George's Respiratory Questionnaire (SGRQ), was converted into EQ-5D-3L health state utility values. Costs were estimated using Danish registers and valued in British pounds (£) at price level 2019. Scenario analyses and probabilistic sensitivity analyses were conducted to assess the uncertainty of the results.

RESULTS

The adjusted mean difference in QALYs between the HFNC group and the control group was 0.059 (95% CI: 0.017; 0.101), and the adjusted mean difference in total costs was £212 (95% CI: -1572; 1995). The analysis resulted in an incremental cost-effectiveness ratio (ICER) of £3605 per QALY gained. At threshold values of £20.000-30.000 per QALY gained, the intervention had an 83-92% probability of being cost-effective. The scenario analyses all revealed ICERs below the set threshold value and demonstrated the robustness of the main result.

CONCLUSION

This is the first cost-effectiveness study on domiciliary HFNC in Europe. The findings demonstrate that long-term domiciliary HFNC treatment is very likely to be a cost-effective addition to usual care for COPD patients with chronic respiratory failure. The results must be interpreted in light of the uncertainty associated with the indirect estimation of health state utilities.

Benefits and risks of noninvasive oxygenation strategy in COVID-19: a multicenter, prospective cohort study (COVID-ICU) in 137 hospitals.

COVID-ICU group, for the REVA network, COVID-ICU investigators. Benefits and risks of noninvasive oxygenation strategy in COVID-19: a multicenter, prospective cohort study (COVID-ICU) in 137 hospitals. Crit Care. 2021;25(1):421. Published 2021 Dec 8. doi:10.1186/s13054-021-03784-2



RATIONAL

To evaluate the respective impact of standard oxygen, high-flow nasal cannula (HFNC) and noninvasive ventilation (NIV) on oxygenation failure rate and mortality in COVID-19 patients admitted to intensive care units (ICUs).

METHODS

Multicenter, prospective cohort study (COVID-ICU) in 137 hospitals in France, Belgium, and Switzerland. Demographic, clinical, respiratory support, oxygenation failure, and survival data were collected. Oxygenation failure was defined as either intubation or death in the ICU without intubation. Variables independently associated with oxygenation failure and Day-90 mortality were assessed using multivariate logistic regression.

RESULTS

From February 25 to May 4, 2020, 4754 patients were admitted in ICU. Of these, 1491 patients were not intubated on the day of ICU admission and received standard oxygen therapy (51%), HFNC (38%), or NIV (11%) (P < 0.001). Oxygenation failure occurred in 739 (50%) patients (678 intubation and 61 death). For standard oxygen, HFNC, and NIV, oxygenation failure rate was 49%, 48%, and 60% (P < 0.001). By multivariate analysis, HFNC (odds ratio [OR] 0.60, 95% confidence interval [CI] 0.36-0.99, P = 0.013) but not NIV (OR 1.57, 95% CI 0.78-3.21) was associated with a reduction in oxygenation failure). Overall 90-day mortality was 21%. By multivariable analysis, HFNC was not associated with a change in mortality (OR 0.90, 95% CI 0.61-1.33), while NIV was associated with increased mortality (OR 2.75, 95% CI 1.79-4.21, P < 0.001).

CONCLUSION

In patients with COVID-19, HFNC was associated with a reduction in oxygenation failure without improvement in 90-day mortality, whereas NIV was associated with a higher mortality in these patients. Randomized controlled trials are needed.

High-Flow Nasal Oxygen for Severe Hypoxemia: Oxygenation Response and Outcome in Patients with COVID-19.

Ranieri VM, Tonetti T, Navalesi P, et al. High-Flow Nasal Oxygen for Severe Hypoxemia: Oxygenation Response and Outcome in Patients with COVID-19. Am J Respir Crit Care Med. 2022;205(4):431-439. doi:10.1164/rccm.202109-2163OC

Rationale: The "Berlin definition" of acute respiratory distress syndrome (ARDS) does not allow inclusion of patients receiving high-flow nasal oxygen (HFNO). However, several articles have proposed that criteria for defining ARDS should be broadened to allow inclusion of patients receiving HFNO. Objectives: To compare the proportion of patients fulfilling ARDS criteria during HFNO and soon after intubation, and 28-day mortality between patients treated exclusively with HFNO and patients transitioned from HFNO to invasive mechanical ventilation (IMV). Methods: From previously published studies, we analyzed patients with coronavirus disease (COVID-19) who had PaO2/FiO2 of ⩽300 while treated with ⩾40 L/min HFNO, or noninvasive ventilation (NIV) with positive end-expiratory pressure of ⩾5 cm H2O (comparator). In patients transitioned from HFNO/NIV to invasive mechanical ventilation (IMV), we compared ARDS severity during HFNO/NIV and soon after IMV. We compared 28-day mortality in patients treated exclusively with HFNO/NIV versus patients transitioned to IMV. Measurements and Main Results: We analyzed 184 and 131 patients receiving HFNO or NIV, respectively. A total of 112 HFNO and 69 NIV patients transitioned to IMV. Of those, 104 (92.9%) patients on HFNO and 66 (95.7%) on NIV continued to have PaO2/FiO2 ⩽300 under IMV. Twenty-eight-day mortality in patients who remained on HFNO was 4.2% (3/72), whereas in patients transitioned from HFNO to IMV, it was 28.6% (32/112) (P < 0.001). Twenty-eight-day mortality in patients who remained on NIV was 1.6% (1/62), whereas in patients who transitioned from NIV to IMV, it was 44.9% (31/69) (P < 0.001). Overall mortality was 19.0% (35/184) and 24.4% (32/131) for HFNO and NIV, respectively (P = 0.2479). Conclusions: Broadening the ARDS definition to include patients on HFNO with PaO2/FiO2 ⩽300 may identify patients at earlier stages of disease but with lower mortality.

Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial.

Perkins GD, Ji C, Connolly BA, et al. Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial. JAMA. 2022;327(6):546-558. doi:10.1001/jama.2022.0028



Importance

Continuous positive airway pressure (CPAP) and high-flow nasal oxygen (HFNO) have been recommended for acute hypoxemic respiratory failure in patients with COVID-19. Uncertainty exists regarding the effectiveness and safety of these noninvasive respiratory strategies.

Objective

To determine whether either CPAP or HFNO, compared with conventional oxygen therapy, improves clinical outcomes in hospitalized patients with COVID-19-related acute hypoxemic respiratory failure.

Design, Setting, and Participants

A parallel group, adaptive, randomized clinical trial of 1273 hospitalized adults with COVID-19-related acute hypoxemic respiratory failure. The trial was conducted between April 6, 2020, and May 3, 2021, across 48 acute care hospitals in the UK and Jersey. Final follow-up occurred on June 20, 2021.

Interventions

Adult patients were randomized to receive CPAP (n = 380), HFNO (n = 418), or conventional oxygen therapy (n = 475).

Main Outcomes and Measures

The primary outcome was a composite of tracheal intubation or mortality within 30 days.

Results

The trial was stopped prematurely due to declining COVID-19 case numbers in the UK and the end of the funded recruitment period. Of the 1273 randomized patients (mean age, 57.4 [95% CI, 56.7 to 58.1] years; 66% male; 65% White race), primary outcome data were available for 1260. Crossover between interventions occurred in 17.1% of participants (15.3% in the CPAP group, 11.5% in the HFNO group, and 23.6% in the conventional oxygen therapy group). The requirement for tracheal intubation or mortality within 30 days was significantly lower with CPAP (36.3%; 137 of 377 participants) vs conventional oxygen therapy (44.4%; 158 of 356 participants) (absolute difference, -8% [95% CI, -15% to -1%], P = .03), but was not significantly different with HFNO (44.3%; 184 of 415 participants) vs conventional oxygen therapy (45.1%; 166 of 368 participants) (absolute difference, -1% [95% CI, -8% to 6%], P = .83). Adverse events occurred in 34.2% (130/380) of participants in the CPAP group, 20.6% (86/418) in the HFNO group, and 13.9% (66/475) in the conventional oxygen therapy group.

Conclusions and Relevance

Among patients with acute hypoxemic respiratory failure due to COVID-19, an initial strategy of CPAP significantly reduced the risk of tracheal intubation or mortality compared with conventional oxygen therapy, but there was no significant difference between an initial strategy of HFNO compared with conventional oxygen therapy. The study may have been underpowered for the comparison of HFNO vs conventional oxygen therapy, and early study termination and crossover among the groups should be considered when interpreting the findings.

Trial Registration

isrctn.org Identifier: ISRCTN16912075.

Helmet continuous positive airway pressure vs. high flow nasal cannula oxygen in acute cardiogenic pulmonary oedema: a randomized controlled trial.

Osman A, Via G, Sallehuddin RM, et al. Helmet continuous positive airway pressure vs. high flow nasal cannula oxygen in acute cardiogenic pulmonary oedema: a randomized controlled trial. Eur Heart J Acute Cardiovasc Care. 2021;10(10):1103-1111. doi:10.1093/ehjacc/zuab078



AIMS

Non-invasive ventilation represents an established treatment for acute cardiogenic pulmonary oedema (ACPO) although no data regarding the best ventilatory strategy are available. We aimed to compare the effectiveness of helmet CPAP (hCPAP) and high flow nasal cannula (HFNC) in the early treatment of ACPO.

METHODS AND RESULTS

Single-centre randomized controlled trial of patients admitted to the emergency department due to ACPO with hypoxemia and dyspnoea on face mask oxygen therapy. Patients were randomly assigned with a 1:1 ratio to receive hCPAP or HFNC and FiO2 set to achieve an arterial oxygen saturation >94%. The primary outcome was a reduction in respiratory rate; secondary outcomes included changes in heart rate, PaO2/FiO2 ratio, Heart rate, Acidosis, Consciousness, Oxygenation, and Respiratory rate (HACOR) score, Dyspnoea Scale, and intubation rate. Data were collected before hCPAP/HFNC placement and after 1 h of treatment. Amongst 188 patients randomized, hCPAP was more effective than HFNC in reducing respiratory rate [-12 (95% CI; 11-13) vs. -9 (95% CI; 8-10), P < 0.001] and was associated with greater heart rate reduction [-20 (95% CI; 17-23) vs. -15 (95% CI; 12-18), P = 0.042], P/F ratio improvement [+149 (95% CI; 135-163) vs. +120 (95% CI; 107-132), P = 0.003] as well as in HACOR scores [6 (0-12) vs. 4 (2-9), P < 0.001] and Dyspnoea Scale [4 (1-7) vs. 3.5 (1-6), P = 0.003]. No differences in intubation rate were noted (P = 0.321).

CONCLUSION

Amongst patients with ACPO, hCPAP resulted in a greater short-term improvement in respiratory and hemodynamic parameters as compared with HFNC.

TRIAL REGISTRATION

Clinical trial submission: NMRR-17-1839-36966 (IIR). Registry name: Medical Research and Ethics Committee of Malaysia Ministry of Health. Clinicaltrials.gov identifier: NCT04005092. URL registry: https://clinicaltrials.gov/ct2/show/NCT04005092.

Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial.

Grieco DL, Menga LS, Cesarano M, et al. Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial. JAMA. 2021;325(17):1731-1743. doi:10.1001/jama.2021.4682



Importance

High-flow nasal oxygen is recommended as initial treatment for acute hypoxemic respiratory failure and is widely applied in patients with COVID-19.

Objective

To assess whether helmet noninvasive ventilation can increase the days free of respiratory support in patients with COVID-19 compared with high-flow nasal oxygen alone.

Design, Setting, and Participants

Multicenter randomized clinical trial in 4 intensive care units (ICUs) in Italy between October and December 2020, end of follow-up February 11, 2021, including 109 patients with COVID-19 and moderate to severe hypoxemic respiratory failure (ratio of partial pressure of arterial oxygen to fraction of inspired oxygen ≤200).

Interventions

Participants were randomly assigned to receive continuous treatment with helmet noninvasive ventilation (positive end-expiratory pressure, 10-12 cm H2O; pressure support, 10-12 cm H2O) for at least 48 hours eventually followed by high-flow nasal oxygen (n = 54) or high-flow oxygen alone (60 L/min) (n = 55).

Main Outcomes and Measures

The primary outcome was the number of days free of respiratory support within 28 days after enrollment. Secondary outcomes included the proportion of patients who required endotracheal intubation within 28 days from study enrollment, the number of days free of invasive mechanical ventilation at day 28, the number of days free of invasive mechanical ventilation at day 60, in-ICU mortality, in-hospital mortality, 28-day mortality, 60-day mortality, ICU length of stay, and hospital length of stay.

Results

Among 110 patients who were randomized, 109 (99%) completed the trial (median age, 65 years [interquartile range {IQR}, 55-70]; 21 women [19%]). The median days free of respiratory support within 28 days after randomization were 20 (IQR, 0-25) in the helmet group and 18 (IQR, 0-22) in the high-flow nasal oxygen group, a difference that was not statistically significant (mean difference, 2 days [95% CI, -2 to 6]; P = .26). Of 9 prespecified secondary outcomes reported, 7 showed no significant difference. The rate of endotracheal intubation was significantly lower in the helmet group than in the high-flow nasal oxygen group (30% vs 51%; difference, -21% [95% CI, -38% to -3%]; P = .03). The median number of days free of invasive mechanical ventilation within 28 days was significantly higher in the helmet group than in the high-flow nasal oxygen group (28 [IQR, 13-28] vs 25 [IQR 4-28]; mean difference, 3 days [95% CI, 0-7]; P = .04). The rate of in-hospital mortality was 24% in the helmet group and 25% in the high-flow nasal oxygen group (absolute difference, -1% [95% CI, -17% to 15%]; P > .99).

Conclusions and Relevance

Among patients with COVID-19 and moderate to severe hypoxemia, treatment with helmet noninvasive ventilation, compared with high-flow nasal oxygen, resulted in no significant difference in the number of days free of respiratory support within 28 days. Further research is warranted to determine effects on other outcomes, including the need for endotracheal intubation.

Trial Registration

ClinicalTrials.gov Identifier: NCT04502576.