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Delclaux C, L'Her E, Alberti C, et al. Treatment of Acute Hypoxemic Nonhypercapnic Respiratory Insufficiency With Continuous Positive Airway Pressure Delivered by a Face Mask: A Randomized Controlled Trial. JAMA. 2000;284(18):2352–2360. doi:10.1001/jama.284.18.2352
Author Affiliations: Medical Intensive Care Unit, Henri Mondor Hospital, Assistance Publique-Hôpitaux de Paris, Créteil, France (Drs Delclaux, Schortgen, Lefort, Lemaire, and Brochard); Institut National de la Santé et de la Recherche Médicale U492, Université Paris, France (Drs Delclaux and Brochard); Medical Intensive Care Unit, La Cavalle Blanche Hospital, Brest, France (Dr L'Her); Intensive Care Unit, Sant Pau Hospital, Barcelona, Spain (Dr Mancebo); Medical Intensive Care Unit, Monastir Hospital, Tunisia (Dr Abroug); Intensive Care Unit, La Sapienza University Hospital, Rome, Italy (Drs Conti and Antonelli); Medical Intensive Care Unit, Croix Rousse Hospital, Lyon, France (Dr Guérin); Department of Biostatistics, Saint Louis Hospital, Paris, France (Dr Alberti); and Department of Biostatistics, Henri Mondor Hospital, Créteil, France (Dr Lepage).
Caring for the Critically Ill Patient Section
Editor: Deborah J. Cook, MD, Consulting Editor, JAMA.
Context Continuous positive airway pressure (CPAP) is widely used in the belief
that it may reduce the need for intubation and mechanical ventilation in patients
with acute hypoxemic respiratory insufficiency.
Objective To compare the physiologic effects and the clinical efficacy of CPAP
vs standard oxygen therapy in patients with acute hypoxemic, nonhypercapnic
Design, Setting, and Patients Randomized, concealed, and unblinded trial of 123 consecutive adult
patients who were admitted to 6 intensive care units between September 1997
and January 1999 with a PaO2/FIO2 ratio of 300 mm Hg
or less due to bilateral pulmonary edema (n = 102 with acute lung injury and
n = 21 with cardiac disease).
Interventions Patients were randomly assigned to receive oxygen therapy alone (n =
61) or oxygen therapy plus CPAP (n = 62).
Main Outcome Measures Improvement in PaO2/FIO2 ratio, rate of endotracheal
intubation at any time during the study, adverse events, length of hospital
stay, mortality, and duration of ventilatory assistance, compared between
the CPAP and standard treatment groups.
Results Among the CPAP vs standard therapy groups, respectively, causes of respiratory
failure (pneumonia, 54% and 55%), presence of cardiac disease (33% and 35%),
severity at admission, and hypoxemia (median [5th-95th percentile] PaO2/FIO2 ratio, 140 [59-288] mm Hg vs 148 [62-283] mm Hg; P = .43) were similarly distributed. After 1 hour of treatment,
subjective responses to treatment (P<.001) and
median (5th-95th percentile) PaO2/FIO2 ratios were greater
with CPAP (203 [45-431] mm Hg vs 151 [73-482] mm Hg; P
= .02). No further difference in respiratory indices was observed between
the groups. Treatment with CPAP failed to reduce the endotracheal intubation
rate (21 [34%] vs 24 [39%] in the standard therapy group; P = .53), hospital mortality (19 [31%] vs 18 [30%]; P = .89), or median (5th-95th percentile) intensive care unit length
of stay (6.5 [1-57] days vs 6.0 [1-36] days; P =
.43). A higher number of adverse events occurred with CPAP treatment (18 vs
6; P = .01).
Conclusion In this study, despite early physiologic improvement, CPAP neither reduced
the need for intubation nor improved outcomes in patients with acute hypoxemic,
nonhypercapnic respiratory insufficiency primarily due to acute lung injury.
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