Evidence map›Paper›PMID 28877705›Full record

Trial reportCritical care (London, England)2017

Loxapine to control agitation during weaning from mechanical ventilation.

Stéphane Gaudry, Benjamin Sztrymf, Romain Sonneville, Bruno Megarbane, Guillaume Van Der Meersch, Dominique Vodovar, Yves Cohen, Jean-Damien Ricard, David Hajage, Laurence Salomon and 1 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Critical care (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01193816 (Assessment of Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01193816 phase4completednot on this map

Assessment of Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2011 to 2014Enrolled100ConditionsRestlessnessArmsloxapine, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 1 country.

Stéphane GaudryService de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris, F-92700, Colombes, France.
Benjamin SztrymfService de Réanimation Polyvalente et surveillance continue, Hôpital Antoine Béclère, Assistance Publique - Hôpitaux de Paris, F-92140, Clamart, France.
Romain SonnevilleService de Réanimation Médicale et maladies infectieuses, Hôpital Bichat, Assistance Publique - Hôpitaux de Paris, Paris, France.
Bruno MegarbaneService de Réanimation Médicale, Hôpital Lariboisière, Assistance Publique - Hôpitaux de Paris, Paris, France.
Guillaume Van Der MeerschService de Réanimation Médico-Chirurgicale, Hôpital Avicenne, Assistance Publique - Hôpitaux de Paris, Bobigny, France.
Dominique VodovarService de Réanimation Médicale, Hôpital Lariboisière, Assistance Publique - Hôpitaux de Paris, Paris, France.
Yves CohenService de Réanimation Médico-Chirurgicale, Hôpital Avicenne, Assistance Publique - Hôpitaux de Paris, Bobigny, France.
Jean-Damien RicardService de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris, F-92700, Colombes, France.
David HajageEpidémiologie Clinique et Évaluation Économique Appliqué aux Populations Vulnérables (ECEVE), UMR 1123, Université Paris Diderot, Sorbonne Paris Cité, F-75018, Paris, France.
Laurence SalomonDépartement d'Epidémiologie et Recherche Clinique, Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris, 178 rue des Renouillers, F-92700, Colombes, France.
Didier DreyfussService de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris, F-92700, Colombes, France. didier.dreyfuss@lmr.aphp.fr.
Assistance Publique – Hôpitaux de Paris · FRSorbonne Paris Cité · FRÉpidémiologie Clinique, Évaluation Économique Appliquées aux Populations Vulnérables · FRHôpital Bichat-Claude-Bernard · FRHôpital Lariboisière · FRUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWeaning from mechanical ventilation (MV) may be impeded by the occurrence of agitation. Loxapine has the ability to control agitation without affecting spontaneous ventilation. The aim of this study was to establish whether loxapine would reduce MV weaning duration in agitated patients.

methodsWe performed a multicentre, double-blind, placebo-controlled, parallel group, randomised trial. Patients who were potential candidates for weaning but exhibited agitation (Richmond Agitation-Sedation Scale score ≥ 2) after sedation withdrawal were randomly assigned to receive either loxapine or placebo. In case of severe agitation, conventional sedation was immediately resumed. The primary endpoint was the time between first administration of loxapine or placebo and successful extubation.

resultsThe trial was discontinued after 102 patients were enrolled because of an insufficient inclusion rate. Median times to successful extubation were 3.2 days in the loxapine group and 5 days in the placebo group (relative risk 1.2, 95% CI 0.75-1.88, p = 0.45). During the first 24 h, sedation was more frequently resumed in the placebo group (44% vs 17%, p = 0.01).

conclusionsIn this prematurely stopped trial, loxapine did not significantly shorten weaning from MV. However, loxapine reduced the need for resuming sedation.

trial registrationClinicaltrials.gov, NCT01193816 . Registered on 26 August 2010.

Indexed as

LoxapinePsychomotor AgitationVentilator WeaningAgedAntipsychotic AgentsDouble-Blind MethodFemaleHumansMaleMiddle AgedPlacebosRespiration, ArtificialTime FactorsAntipsychotic AgentsLoxapinePlacebosAgitationIntensive care unitMechanical ventilationVentilation weaning

Identifiers

PMID28877705
PMCPMC5586048
OpenAlexW2752389540

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.