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- Title
Effect of On-Demand vs Routine Nebulization of Acetylcysteine With Salbutamol on Ventilator-Free Days in Intensive Care Unit Patients Receiving Invasive Ventilation: A Randomized Clinical Trial.
- Authors
van Meenen, David M. P.; van der Hoeven, Sophia M.; Binnekade, Jan M.; de Borgie, Corianne A. J. M.; Merkus, Maruschka P.; Bosch, Frank H.; Endeman, Henrik; Haringman, Jasper J.; van der Meer, Nardo J. M.; Moeniralam, Hazra S.; Slabbekoorn, Mathilde; Muller, Marcella C. A.; Stilma, Willemke; van Silfhout, Bart; Neto, Ary Serpa; ter Haar, Hans F. M.; Van Vliet, Jan; Wijnhoven, Jan Willem; Horn, Janneke; Juffermans, Nicole P.
- Abstract
<bold>Importance: </bold>It remains uncertain whether nebulization of mucolytics with bronchodilators should be applied for clinical indication or preventively in intensive care unit (ICU) patients receiving invasive ventilation.<bold>Objective: </bold>To determine if a strategy that uses nebulization for clinical indication (on-demand) is noninferior to one that uses preventive (routine) nebulization.<bold>Design, Setting, and Participants: </bold>Randomized clinical trial enrolling adult patients expected to need invasive ventilation for more than 24 hours at 7 ICUs in the Netherlands.<bold>Interventions: </bold>On-demand nebulization of acetylcysteine or salbutamol (based on strict clinical indications, n = 471) or routine nebulization of acetylcysteine with salbutamol (every 6 hours until end of invasive ventilation, n = 473).<bold>Main Outcomes and Measures: </bold>The primary outcome was the number of ventilator-free days at day 28, with a noninferiority margin for a difference between groups of -0.5 days. Secondary outcomes included length of stay, mortality rates, occurrence of pulmonary complications, and adverse events.<bold>Results: </bold>Nine hundred twenty-two patients (34% women; median age, 66 (interquartile range [IQR], 54-75 years) were enrolled and completed follow-up. At 28 days, patients in the on-demand group had a median 21 (IQR, 0-26) ventilator-free days, and patients in the routine group had a median 20 (IQR, 0-26) ventilator-free days (1-sided 95% CI, -0.00003 to ∞). There was no significant difference in length of stay or mortality, or in the proportion of patients developing pulmonary complications, between the 2 groups. Adverse events (13.8% vs 29.3%; difference, -15.5% [95% CI, -20.7% to -10.3%]; P < .001) were more frequent with routine nebulization and mainly related to tachyarrhythmia (12.5% vs 25.9%; difference, -13.4% [95% CI, -18.4% to -8.4%]; P < .001) and agitation (0.2% vs 4.3%; difference, -4.1% [95% CI, -5.9% to -2.2%]; P < .001).<bold>Conclusions and Relevance: </bold>Among ICU patients receiving invasive ventilation who were expected to not be extubated within 24 hours, on-demand compared with routine nebulization of acetylcysteine with salbutamol did not result in an inferior number of ventilator-free days. On-demand nebulization may be a reasonable alternative to routine nebulization.<bold>Trial Registration: </bold>clinicaltrials.gov Identifier: NCT02159196.
- Subjects
ALBUTEROL; ARTIFICIAL respiration; COMPARATIVE studies; CRITICAL care medicine; LENGTH of stay in hospitals; INTENSIVE care units; RESEARCH methodology; MEDICAL cooperation; RESEARCH; RESPIRATORY therapy equipment; STATISTICAL sampling; MECHANICAL ventilators; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; ACETYLCYSTEINE; INHALATION administration
- Publication
JAMA: Journal of the American Medical Association, 2018, Vol 319, Issue 10, p993
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2018.0949