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
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. To determine if a strategy that uses nebulization for clinical indication (on-demand) is noninf...
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| Published in: | JAMA : the journal of the American Medical Association Vol. 319; no. 10; p. 993 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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13.03.2018
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| ISSN: | 1538-3598, 1538-3598 |
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| Abstract | 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.
To determine if a strategy that uses nebulization for clinical indication (on-demand) is noninferior to one that uses preventive (routine) nebulization.
Randomized clinical trial enrolling adult patients expected to need invasive ventilation for more than 24 hours at 7 ICUs in the Netherlands.
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).
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.
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).
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.
clinicaltrials.gov Identifier: NCT02159196. |
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| AbstractList | 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.
To determine if a strategy that uses nebulization for clinical indication (on-demand) is noninferior to one that uses preventive (routine) nebulization.
Randomized clinical trial enrolling adult patients expected to need invasive ventilation for more than 24 hours at 7 ICUs in the Netherlands.
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).
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.
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).
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.
clinicaltrials.gov Identifier: NCT02159196. 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.ImportanceIt 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.To determine if a strategy that uses nebulization for clinical indication (on-demand) is noninferior to one that uses preventive (routine) nebulization.ObjectiveTo determine if a strategy that uses nebulization for clinical indication (on-demand) is noninferior to one that uses preventive (routine) nebulization.Randomized clinical trial enrolling adult patients expected to need invasive ventilation for more than 24 hours at 7 ICUs in the Netherlands.Design, Setting, and ParticipantsRandomized clinical trial enrolling adult patients expected to need invasive ventilation for more than 24 hours at 7 ICUs in the Netherlands.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).InterventionsOn-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).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.Main Outcomes and MeasuresThe 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.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).ResultsNine 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).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.Conclusions and RelevanceAmong 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.clinicaltrials.gov Identifier: NCT02159196.Trial Registrationclinicaltrials.gov Identifier: NCT02159196. |
| Author | Slabbekoorn, Mathilde Neto, Ary Serpa Van Vliet, Jan Muller, Marcella C A Schultz, Marcus J Paulus, Frederique Ter Haar, Hans F M Juffermans, Nicole P Binnekade, Jan M Pelosi, Paolo van der Hoeven, Sophia M van Silfhout, Bart Endeman, Henrik Gama de Abreu, Marcelo Stilma, Willemke Moeniralam, Hazra S Wijnhoven, Jan Willem van Meenen, David M P Merkus, Maruschka P Haringman, Jasper J Horn, Janneke de Borgie, Corianne A J M Bosch, Frank H van der Meer, Nardo J M |
| Author_xml | – sequence: 1 givenname: David M P surname: van Meenen fullname: van Meenen, David M P organization: Department of Intensive Care, Academic Medical Center, University of Amsterdam, the Netherlands – sequence: 2 givenname: Sophia M surname: van der Hoeven fullname: van der Hoeven, Sophia M organization: Department of Intensive Care, Academic Medical Center, University of Amsterdam, the Netherlands – sequence: 3 givenname: Jan M surname: Binnekade fullname: Binnekade, Jan M organization: Department of Intensive Care, Academic Medical Center, University of Amsterdam, the Netherlands – sequence: 4 givenname: Corianne A J M surname: de Borgie fullname: de Borgie, Corianne A J M organization: Clinical Research Unit, Academic Medical Center, University of Amsterdam, the Netherlands – sequence: 5 givenname: Maruschka P surname: Merkus fullname: Merkus, Maruschka P organization: Clinical Research Unit, Academic Medical Center, University of Amsterdam, the Netherlands – sequence: 6 givenname: Frank H surname: Bosch fullname: Bosch, Frank H organization: Department of Intensive Care, Rijnstate, Arnhem, the Netherlands – sequence: 7 givenname: Henrik surname: Endeman fullname: Endeman, Henrik organization: Department of Intensive Care, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands – sequence: 8 givenname: Jasper J surname: Haringman fullname: Haringman, Jasper J organization: Department of Intensive Care, Isala Hospital, Zwolle, the Netherlands – sequence: 9 givenname: Nardo J M surname: van der Meer fullname: van der Meer, Nardo J M organization: Department of Intensive Care, Amphia Hospital, Breda, the Netherlands – sequence: 10 givenname: Hazra S surname: Moeniralam fullname: Moeniralam, Hazra S organization: Department of Intensive Care, Antonius Hospital, Nieuwegein, the Netherlands – sequence: 11 givenname: Mathilde surname: Slabbekoorn fullname: Slabbekoorn, Mathilde organization: Department of Intensive Care, Haaglanden Medical Center, The Hague, the Netherlands – sequence: 12 givenname: Marcella C A surname: Muller fullname: Muller, Marcella C A organization: Department of Intensive Care, Haaglanden Medical Center, The Hague, the Netherlands – sequence: 13 givenname: Willemke surname: Stilma fullname: Stilma, Willemke organization: Department of Intensive Care, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands – sequence: 14 givenname: Bart surname: van Silfhout fullname: van Silfhout, Bart organization: Department of Intensive Care, Antonius Hospital, Nieuwegein, the Netherlands – sequence: 15 givenname: Ary Serpa surname: Neto fullname: Neto, Ary Serpa organization: Department of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil – sequence: 16 givenname: Hans F M surname: Ter Haar fullname: Ter Haar, Hans F M organization: Department of Intensive Care, Isala Hospital, Zwolle, the Netherlands – sequence: 17 givenname: Jan surname: Van Vliet fullname: Van Vliet, Jan organization: Department of Intensive Care, Rijnstate, Arnhem, the Netherlands – sequence: 18 givenname: Jan Willem surname: Wijnhoven fullname: Wijnhoven, Jan Willem organization: Department of Intensive Care, Amphia Hospital, Breda, the Netherlands – sequence: 19 givenname: Janneke surname: Horn fullname: Horn, Janneke organization: Laboratory of Experimental Intensive Care and Anesthesiology, Academic Medical Center, University of Amsterdam, the Netherlands – sequence: 20 givenname: Nicole P surname: Juffermans fullname: Juffermans, Nicole P organization: Laboratory of Experimental Intensive Care and Anesthesiology, Academic Medical Center, University of Amsterdam, the Netherlands – sequence: 21 givenname: Paolo surname: Pelosi fullname: Pelosi, Paolo organization: Department of Surgical Sciences and Integrated Diagnostics, San Martino Policlinico Hospital, IRCCS for Oncology, University of Genoa, Genoa, Italy – sequence: 22 givenname: Marcelo surname: Gama de Abreu fullname: Gama de Abreu, Marcelo organization: Pulmonary Engineering Group, Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus; Technische Universität Dresden, Dresden, Germany – sequence: 23 givenname: Marcus J surname: Schultz fullname: Schultz, Marcus J organization: Mahidol Oxford Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand – sequence: 24 givenname: Frederique surname: Paulus fullname: Paulus, Frederique organization: Department of Intensive Care, Academic Medical Center, University of Amsterdam, the Netherlands |
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| References_xml | – reference: 26602786 - Intensive Care Med. 2016 Feb;42(2):192-201 – reference: 24975568 - J Crit Care. 2014 Oct;29(5):814-6 – reference: 26329352 - Trials. 2015 Sep 02;16:389 – reference: 12088552 - Respir Care. 2002 Jul;47(7):818-22 – reference: 21121836 - N Engl J Med. 2010 Dec 2;363(23 ):2233-47 – reference: 28418487 - JAMA. 2017 Apr 18;317(15):1583-1584 – reference: 28737047 - Expert Rev Respir Med. 2017 Oct;11(10 ):807-814 – reference: 11560553 - Br J Clin Pharmacol. 2001 Sep;52(3):223-8 – reference: 26170516 - Iran J Med Sci. 2015 Jul;40(4):309-15 – reference: 5427399 - Am Rev Respir Dis. 1970 Jul;102(1):17-22 – reference: 28874611 - Respir Care. 2017 Oct;62(10 ):1343-1367 – reference: 26700442 - Lancet Respir Med. 2016 Jan;4(1):59-72 – reference: 12163791 - Crit Care Med. 2002 Aug;30(8):1772-7 – reference: 21539749 - Trials. 2011 May 03;12:106 – reference: 22797452 - JAMA. 2012 Jun 20;307(23):2526-33 – reference: 17261202 - Respir Care. 2007 Feb;52(2):154-8 – reference: 7485927 - Anaesthesist. 1995 Sep;44(9):651-8 – reference: 19388888 - Acta Anaesthesiol Scand. 2009 Jul;53(6):710-6 – reference: 26975785 - JAMA. 2016 Apr 12;315(14):1469-79 – reference: 8275739 - Chest. 1994 Jan;105(1):237-41 – reference: 23525741 - Intensive Care Med. 2013 Jun;39(6):1048-56 – reference: 16420655 - Crit Care. 2006 Feb;10(1):R11 |
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| SubjectTerms | Acetylcysteine - administration & dosage Administration, Inhalation Adult Aged Albuterol - administration & dosage Critical Care Female Humans Intensive Care Units Length of Stay Male Middle Aged Nebulizers and Vaporizers Respiration, Artificial Treatment Outcome Ventilator Weaning |
| 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 |
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