Evidence map›Paper›PMID 28790042›Full record

Trial reportBMJ open2017

Multicentre randomised controlled trial to investigate the usefulness of continuous pneumatic regulation of tracheal cuff pressure for reducing ventilator-associated pneumonia in mechanically ventilated severe trauma patients: the AGATE study protocol.

Nicolas Marjanovic, Denis Frasca, Karim Asehnoune, Catherine Paugam, Sigismond Lasocki, Carole Ichai, Jean-Yves Lefrant, Marc Leone, Claire Dahyot-Fizelier, Julien Pottecher and 7 more

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

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02534974 (Impact of the Addition of a Device Providing Continuous Pneumatic Regulation of Tube Cuff Pressure to an Overall Strategy Aimed at Preventing Ventilator-associated Pneumonia in the Severe Trauma Patient. A Multicentre, Randomised, Controlled Study.), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 21% 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.

NCT02534974 nacompletednot on this map

Impact of the Addition of a Device Providing Continuous Pneumatic Regulation of Tube Cuff Pressure to an Overall Strategy Aimed at Preventing Ventilator-associated Pneumonia in the Severe Trauma Patient. A Multicentre, Randomised, Controlled Study.

TypeinterventionalSponsorPoitiers University HospitalRan2015 to 2018Enrolled440ConditionsVentilation-associated Pneumonia, Severe Trauma PatientArmsNOSTEN
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 20 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. 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

17 authors at 12 institutions in 1 country.

Nicolas MarjanovicDepartment of Emergency and Prehospital Care, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.
Denis FrascaINSERM UMR1246-Methods in Patient-Centered Outcomes and Health Research, Poitiers, France.
Karim AsehnouneCentre Hospitalier Universitaire de Nantes, Anaesthesia and Intensive Care Unit, Nantes, France.
Catherine PaugamAssistance Publique des Hôpitaux de Paris, Intensive Care Unit, Hôpital Beaujon, Clichy, France.
Sigismond LasockiCentre Hospitalier Universitaire d'Angers, Intensive Care Unit, Angers, France.
Carole IchaiCentre Hospitalier Universitaire de Nice, Intensive Care Unit, Nice, France.
Jean-Yves LefrantDivision Anaesthesia Critical Care, Emergency and Pain Medicine, Centre Hospitalier Universitaire de Nimes, Nimes, France.
Marc LeoneAssistance Publique Hopitaux de Marseille, Intensive Care Unit, Hôpital Nord, Marseille, France.
Claire Dahyot-FizelierCentre Hospitalier Universitaire de Poitiers, Neuro-Intensive Care Unit, Poitiers, France.
Julien PottecherHopitaux Universitaires de Strasbourg, Intensive Care Unit, Strasbourg, France.
Dominique FalconCentre Hospitalier Universitaire de Grenoble, Intensive Care Unit, Grenoble, France.
Benoit VeberCentre Hospitalier Universitaire de Rouen, Intensive Care Unit, Rouen, France.
Jean-Michel ConstantinCentre Hospitalier Universitaire de Clermont-Ferrand, Intensive Care Unit, Clermont-Ferrand, France.
Sabrina SeguinDepartment of Emergency and Prehospital Care, Centre Hospitalier Universitaire de Poitiers, Intensive Care Unit, Poitiers, France.
Jérémy GuénézanDepartment of Emergency and Prehospital Care, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.
Olivier MimozDepartment of Emergency and Prehospital Care, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.
AGATE study group
Centre Hospitalier Universitaire de Poitiers · FRInserm · FRAssistance Publique Hôpitaux de Marseille · FRCentre Hospitalier Universitaire d'Angers · FRCentre Hospitalier Universitaire de Grenoble · FRCentre Hospitalier Universitaire de Nantes · FRCentre Hospitalier Universitaire de Nîmes · FRCentre Hospitalier Universitaire de Rouen · FRHôpital Beaujon · FRHôpitaux Universitaires de Strasbourg · FRUniversité Clermont Auvergne · FRUniversité Joseph Fourier · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSevere trauma represents the leading cause of mortality worldwide. While 80% of deaths occur within the first 24 hours after trauma, 20% occur later and are mainly due to healthcare-associated infections, including ventilator-associated pneumonia (VAP). Preventing underinflation of the tracheal cuff is recommended to reduce microaspiration, which plays a major role in the pathogenesis of VAP. Automatic devices facilitate the regulation of tracheal cuff pressure, and their implementation has the potential to reduce VAP. The objective of this work is to determine whether continuous regulation of tracheal cuff pressure using a pneumatic device reduces the incidence of VAP compared with intermittent control in severe trauma patients. METHODS AND ANALYSIS: This multicentre randomised controlled and open-label trial will include patients suffering from severe trauma who are admitted within the first 24 hours, who require invasive mechanical ventilation to longer than 48 hours. Their tracheal cuff pressure will be monitored either once every 8 hours (control group) or continuously using a pneumatic device (intervention group). The primary end point is the proportion of patients that develop VAP in the intensive care unit (ICU) at day 28. The secondary end points include the proportion of patients that develop VAP in the ICU, early (≤7 days) or late (>7 days) VAP, time until the first VAP diagnosis, the number of ventilator-free days and antibiotic-free days, the length of stay in the ICU, the proportion of patients with ventilator-associated events and that die during their ICU stay. ETHICS AND DISSEMINATION: This protocol has been approved by the ethics committee of Poitiers University Hospital, and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.

trial registrationClinical Trials NCT02534974.

Indexed as

Continuous Positive Airway PressureCritical IllnessFemaleGlasgow Coma ScaleHumansIntensive Care UnitsIntubation, IntratrachealMalePilot ProjectsPneumonia, Ventilator-AssociatedPressureRisk FactorsWounds and Injurieslung diseasespneumoniapneumonia, ventilator-asssociatedrespiratory tract diseaseswounds and injuries

Identifiers

PMID28790042
PMCPMC5724199
OpenAlexW2742774451

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.