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A Randomized Trial

Massimo Antonelli, MD; Giorgio Conti, MD; Maurizio Bufi, MD; Maria Gabriella Costa, MD; Angela Lappa, MD; Monica Rocco, MD; Alessandro Gasparetto, MD; Gianfranco Umberto Meduri, MD

JAMA. 2000;283:235-241.

Context  Noninvasive ventilation (NIV) has been associated with lower rates of endotracheal intubation in populations of patients with acute respiratory failure.

Objective  To compare NIV with standard treatment using supplemental oxygen administration to avoid endotracheal intubation in recipients of solid organ transplantation with acute hypoxemic respiratory failure.

Design and Setting  Prospective randomized study conducted at a 14-bed, general intensive care unit of a university hospital.

Patients  Of 238 patients who underwent solid organ transplantation from December 1995 to October 1997, 51 were treated for acute respiratory failure. Of these, 40 were eligible and 20 were randomized to each group.

Intervention  Noninvasive ventilation vs standard treatment with supplemental oxygen administration.

Main Outcome Measures  The need for endotracheal intubation and mechanical ventilation at any time during the study, complications not present on admission, duration of ventilatory assistance, length of hospital stay, and intensive care unit mortality.

Results  The 2 groups were similar at study entry. Within the first hour of treatment, 14 patients (70%) in the NIV group, and 5 patients (25%) in the standard treatment group improved their ratio of the PaO₂ to the fraction of inspired oxygen (FIO₂). Over time, a sustained improvement in PaO₂ to FIO₂ was noted in 12 patients (60%) in the NIV group, and in 5 patients (25%) randomized to standard treatment (P = .03). The use of NIV was associated with a significant reduction in the rate of endotracheal intubation (20% vs 70%; P = .002), rate of fatal complications (20% vs 50%; P = .05), length of stay in the intensive care unit by survivors (mean [SD] days, 5.5 [3] vs 9 [4]; P = .03), and intensive care unit mortality (20% vs 50%; P = .05). Hospital mortality did not differ.

Conclusions  These results indicate that transplantation programs should consider NIV in the treatment of selected recipients of transplantation with acute respiratory failure.

Author Affiliations: Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore Rome, Italy (Drs Antonelli and Conti), Università La Sapienza Policlinico Umberto I, Rome (Drs Bufi, Costa, Lappa, Rocco, and Gasparetto); and the Department of Medicine, Pulmonary and Critical Care Division, Memphis Lung Research Program, University of Tennessee, Memphis (Dr Meduri).

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