Document Detail


A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial.
MedLine Citation:
PMID:  20116842     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Standard treatment of critically ill patients undergoing mechanical ventilation is continuous sedation. Daily interruption of sedation has a beneficial effect, and in the general intesive care unit of Odense University Hospital, Denmark, standard practice is a protocol of no sedation. We aimed to establish whether duration of mechanical ventilation could be reduced with a protocol of no sedation versus daily interruption of sedation.
METHODS: Of 428 patients assessed for eligibility, we enrolled 140 critically ill adult patients who were undergoing mechanical ventilation and were expected to need ventilation for more than 24 h. Patients were randomly assigned in a 1:1 ratio (unblinded) to receive: no sedation (n=70 patients); or sedation (20 mg/mL propofol for 48 h, 1 mg/mL midazolam thereafter) with daily interruption until awake (n=70, control group). Both groups were treated with bolus doses of morphine (2.5 or 5 mg). The primary outcome was the number of days without mechanical ventilation in a 28-day period, and we also recorded the length of stay in the intensive care unit (from admission to 28 days) and in hospital (from admission to 90 days). Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00466492.
FINDINGS: 27 patients died or were successfully extubated within 48 h, and, as per our study design, were excluded from the study and statistical analysis. Patients receiving no sedation had significantly more days without ventilation (n=55; mean 13.8 days, SD 11.0) than did those receiving interrupted sedation (n=58; mean 9.6 days, SD 10.0; mean difference 4.2 days, 95% CI 0.3-8.1; p=0.0191). No sedation was also associated with a shorter stay in the intensive care unit (HR 1.86, 95% CI 1.05-3.23; p=0.0316), and, for the first 30 days studied, in hospital (3.57, 1.52-9.09; p=0.0039), than was interrupted sedation. No difference was recorded in the occurrences of accidental extubations, the need for CT or MRI brain scans, or ventilator-associated pneumonia. Agitated delirium was more frequent in the intervention group than in the control group (n=11, 20%vs n=4, 7%; p=0.0400).
INTERPRETATION: No sedation of critically ill patients receiving mechanical ventilation is associated with an increase in days without ventilation. A multicentre study is needed to establish whether this effect can be reproduced in other facilities.
FUNDING: Danish Society of Anesthesiology and Intensive Care Medicine, the Fund of Danielsen, the Fund of Kirsten Jensa la Cour, and the Fund of Holger og Ruth Hess.
Authors:
Thomas Strøm; Torben Martinussen; Palle Toft
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-01-29
Journal Detail:
Title:  Lancet     Volume:  375     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2010 Feb 
Date Detail:
Created Date:  2010-02-15     Completed Date:  2010-03-08     Revised Date:  2011-04-07    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  475-80     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2010 Elsevier Ltd. All rights reserved.
Affiliation:
Department of Anesthesia and Intensive Care Medicine, Odense University Hospital, University of Southern Denmark, Denmark. t.s@dadlnet.dk
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00466492
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MeSH Terms
Descriptor/Qualifier:
Aged
Clinical Protocols
Critical Illness / mortality,  therapy*
Denmark
Drug Administration Schedule
Female
Humans
Hypnotics and Sedatives / administration & dosage*
Infusions, Intravenous
Intensive Care / methods
Length of Stay
Male
Midazolam / administration & dosage*
Middle Aged
Propofol / administration & dosage*
Prospective Studies
Respiration, Artificial / adverse effects,  methods*,  mortality
Time Factors
Ventilator Weaning
Chemical
Reg. No./Substance:
0/Hypnotics and Sedatives; 2078-54-8/Propofol; 59467-70-8/Midazolam
Comments/Corrections
Comment In:
Crit Care. 2010;14(6):339   [PMID:  21144006 ]
Lancet. 2010 Feb 6;375(9713):436-8   [PMID:  20116840 ]
Lancet. 2010 Apr 3;375(9721):1159; author reply 1160   [PMID:  20362806 ]
Lancet. 2010 Apr 3;375(9721):1159; author reply 1160   [PMID:  20362805 ]
Lancet. 2010 Apr 3;375(9721):1159-60; author reply 1160   [PMID:  20362804 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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