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Lancet Respir Med. 2017 Oct;5(10):795-805. doi: 10.1016/S2213-2600(17)30304-1. Epub 2017 Sep 18.

Immediate interruption of sedation compared with usual sedation care in critically ill postoperative patients (SOS-Ventilation): a randomised, parallel-group clinical trial.

Author information

1
Department of Anaesthesia and Intensive Care, Montpellier University Saint Eloi Hospital, Montpellier, France; PhyMedExp, University of Montpellier, INSERM U1046, CNRS UMR 9214, Montpellier, France. Electronic address: g-chanques@chu-montpellier.fr.
2
Department of Anaesthesia and Intensive Care, Montpellier University Saint Eloi Hospital, Montpellier, France.
3
Department of Anaesthesia, Intensive Care, Pain and Emergency, Hôpital Carémeau, CHU de Nîmes, Nîmes, France.
4
GReD, UMR/CNRS6293, INSERM U1103, Université Clermont Auvergne, Clermont-Ferrand, France; Department of Perioperative Medicine, Hôpital Estaing, CHU de Clermont-Ferrand, Clermont-Ferrand, France.
5
Department of Anaesthesia and Intensive Care, Montpellier University Saint Eloi Hospital, Montpellier, France; PhyMedExp, University of Montpellier, INSERM U1046, CNRS UMR 9214, Montpellier, France.
6
Department of Medical Information, Hôpital de la Colombière, Montpellier, France.
7
Department of Medical Information, Hôpital de la Colombière, Montpellier, France; PhyMedExp, University of Montpellier, INSERM U1046, CNRS UMR 9214, Montpellier, France.

Abstract

BACKGROUND:

Avoidance of excessive sedation and subsequent prolonged mechanical ventilation in intensive care units (ICUs) is recommended, but no data are available for critically ill postoperative patients. We hypothesised that in such patients stopping sedation immediately after admission to the ICU could reduce unnecessary sedation and improve patient outcomes.

METHODS:

We did a randomised, parallel-group, clinical trial at three ICUs in France. Stratified randomisation with minimisation (1:1 via a restricted web platform) was used to assign eligible patients (aged ≥18 years, admitted to an ICU after abdominal surgery, and expected to require at least 12 h of mechanical ventilation because of a critical illness defined by a Sequential Organ Failure Assessment score >1 for any organ, but without severe acute respiratory distress syndrome or brain injury) to usual sedation care provided according to recommended practices (control group) or to immediate interruption of sedation (intervention group). The primary outcome was the time to successful extubation (defined as the time from randomisation to the time of extubation [or tracheotomy mask] for at least 48 h). All patients who underwent randomisation (except for those who were excluded after randomisation) were included in the intention-to-treat analysis. This study is registered with ClinicalTrials.gov, number NCT01486121.

FINDINGS:

Between Dec 2, 2011, and Feb 27, 2014, 137 patients were randomly assigned to the control (n=68) or intervention groups (n=69). In the intention-to-treat analysis, time to successful extubation was significantly lower in the intervention group than in the control group (median 8 h [IQR 4-36] vs 50 h [29-93], group difference -33·6 h [95% CI -44·9 to -22·4]; p<0·0001). The adjusted hazard ratio was 5·2 (95% CI 3·1-8·8, p<0·0001).

INTERPRETATION:

Immediate interruption of sedation in critically ill postoperative patients with organ dysfunction who were admitted to the ICU after abdominal surgery improved outcomes compared with usual sedation care. These findings support interruption of sedation in these patients following transfer from the operating room.

FUNDING:

Délégation à la Recherche Clinique et à l'Innovation du Groupement de Coopération Sanitaire de la Mission d'Enseignement, de Recherche, de Référence et d'Innovation (DRCI-GCS-MERRI) de Montpellier-Nîmes.

PMID:
28935558
DOI:
10.1016/S2213-2600(17)30304-1
[Indexed for MEDLINE]

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