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JAMA. 2018 Oct 24. doi: 10.1001/jama.2018.14282. [Epub ahead of print]

Effect of High-Flow Nasal Oxygen vs Standard Oxygen on 28-Day Mortality in Immunocompromised Patients With Acute Respiratory Failure: The HIGH Randomized Clinical Trial.

Author information

1
Medical Intensive Care Unit and Department of Biostatistics, APHP, Hôpital St-Louis, Paris, France.
2
Intensive Care Unit, Paoli Calmettes Institut, Marseille, France.
3
Critical Care Center, CHU de Lille, Lille, France.
4
Medical Intensive Care Unit, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France.
5
Medical Intensive Care Unit, Hôpital Cochin, APHP, Université Paris Descartes, Paris, France.
6
Medical Intensive Care Unit, INSERM U1088, Amiens University Hospital, Amiens, France.
7
Medical Intensive Care Unit, André Mignot Hospital, Versailles, France.
8
Medical Intensive Care Unit, CHU de Montpellier, Montpellier, France.
9
Medical Intensive Care Unit, La Source Hospital, CHR Orléans, Orléans, France.
10
Medical Intensive Care Unit, Hotel Dieu, CHU de Nantes, Nantes, France.
11
Intensive Care Unit, Institut Gustave Roussy, Villejuif, France.
12
Intensive Care Unit, CHR de Metz-Thionville, Metz, France.
13
Department of Perioperative Medicine, CHU Clermont-Ferrand, Clermont-Ferrand, France.
14
Medical Intensive Care Unit and Respiratory Division, APHP, Hôpital Pitié-Salpêtrière, Sorbonne University, Paris, France.
15
Intensive Care Unit, Lyon Sud Medical Center, Lyon, France.
16
Medical Intensive Care Unit, CHRU, Angers, France.
17
Intensive Care Unit, Centre Hospitalier Métropole-Savoie, Chambery, France.
18
Medical Intensive Care Unit, Hôpital Brabois, Vandoeuvre Les Nancy, France.
19
Medical Intensive Care Unit, Hôpital Charles Nicolle, Rouen, France.
20
Montpellier University Hospital, PhyMedExp, INSERM U-1046, CNRS 34295 Montpellier, France.
21
Medical Intensive Care Unit, Avicenne University Hospital, Bobigny, France.
22
Intensive Care Unit, Roubaix hospital, Roubaix, France.
23
Medical Intensive Care Unit, CHU de Grenoble Alpes, Grenoble, France.
24
Medical Intensive Care Unit, CHU Bichat, Paris, France.
25
Intensive Care Unit, Centre Hospitalier Départemental Les Oudairies, La Roche Sur Yon, France.
26
Medical Intensive Care Unit, Gabriel-Montpied University Hospital, Clermont-Ferrand, France.
27
Medical Intensive Care Unit, CHU St-Antoine, Paris, France.
28
Department of Anesthesia and Critical Care, Necker Hospital, Paris, France.
29
Réanimation des Détresses Respiratoires et Infections Sévères, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Aix-Marseille Université, Faculté de Médecine, Marseille, France.
30
Respiratory Intensive Care Unit, Hôpital Cochin, Paris, France.

Abstract

Importance:

High-flow nasal oxygen therapy is increasingly used for acute hypoxemic respiratory failure (AHRF).

Objective:

To determine whether high-flow oxygen therapy decreases mortality among immunocompromised patients with AHRF compared with standard oxygen therapy.

Design, Setting, and Participants:

The HIGH randomized clinical trial enrolled 776 adult immunocompromised patients with AHRF (Pao2 <60 mm Hg or Spo2 <90% on room air, or tachypnea >30/min or labored breathing or respiratory distress, and need for oxygen ≥6 L/min) at 32 intensive care units (ICUs) in France between May 19, 2016, and December 31, 2017.

Interventions:

Patients were randomized 1:1 to continuous high-flow oxygen therapy (n = 388) or to standard oxygen therapy (n = 388).

Main Outcomes and Measures:

The primary outcome was day-28 mortality. Secondary outcomes included intubation and mechanical ventilation by day 28, Pao2:Fio2 ratio over the 3 days after intubation, respiratory rate, ICU and hospital lengths of stay, ICU-acquired infections, and patient comfort and dyspnea.

Results:

Of 778 randomized patients (median age, 64 [IQR, 54-71] years; 259 [33.3%] women), 776 (99.7%) completed the trial. At randomization, median respiratory rate was 33/min (IQR, 28-39) vs 32 (IQR, 27-38) and Pao2:Fio2 was 136 (IQR, 96-187) vs 128 (IQR, 92-164) in the intervention and control groups, respectively. Median SOFA score was 6 (IQR, 4-8) in both groups. Mortality on day 28 was not significantly different between groups (35.6% vs 36.1%; difference, -0.5% [95% CI, -7.3% to +6.3%]; hazard ratio, 0.98 [95% CI, 0.77 to 1.24]; P = .94). Intubation rate was not significantly different between groups (38.7% vs 43.8%; difference, -5.1% [95% CI, -12.3% to +2.0%]). Compared with controls, patients randomized to high-flow oxygen therapy had a higher Pao2:Fio2 (150 vs 119; difference, 19.5 [95% CI, 4.4 to 34.6]) and lower respiratory rate after 6 hours (25/min vs 26/min; difference, -1.8/min [95% CI, -3.2 to -0.2]). No significant difference was observed in ICU length of stay (8 vs 6 days; difference, 0.6 [95% CI, -1.0 to +2.2]), ICU-acquired infections (10.0% vs 10.6%; difference, -0.6% [95% CI, -4.6 to +4.1]), hospital length of stay (24 vs 27 days; difference, -2 days [95% CI, -7.3 to +3.3]), or patient comfort and dyspnea scores.

Conclusions and Relevance:

Among critically ill immunocompromised patients with acute respiratory failure, high-flow oxygen therapy did not significantly decrease day-28 mortality compared with standard oxygen therapy.

Trial Registration:

clinicaltrials.gov Identifier: NCT02739451.

PMID:
30357270
DOI:
10.1001/jama.2018.14282

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