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. (AGATE)

April 24, 2019 updated by: Poitiers University Hospital

Ventilation-associated pneumonia is the main site of healthcare-associated infections in the severe trauma patient, with a mean incidence rate of 35%. Ventilator-associated pneumonia increases morbi-mortality, length of stay in intensive care and overall management costs. As was recalled by the jury of the 2008 SFAR-SRLF consensus conference on the prevention of nosocomial infections contracted in intensive care, success in this preventive endeavour depends on a number of measures: orotracheal intubation route, maintaining tube cuff pressure between 25 and 30 cm H2O, maintaining a semi-seated position ≥30°, nasal and oropharyngeal care at regular intervals, striving to avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for early weaning from ventilation.

Devices ensuring continuous pneumatic control of tube cuff pressure are more efficient in maintaining tracheal balloon pressure than intermittent adjustments using a hand-held manometer. In one study, these devices clearly facilitated diminution of microaspiration of gastric contents and of ventilator-associated pneumonia incidence density (9.7 vs. 22 VAP/1000 days of mechanical ventilation; p = 0.005).

The investigators are putting forward the hypothesis that by adjoining a device providing continuous pneumatic regulation of tube cuff pressure to an overall strategy aimed at ventilator-associated pneumonia prevention (including semi-recumbent position ≥30°, oro-nasal-pharyngeal care at regular intervals and reduced risk exposure) can decrease VAP incidence by 50% in severely traumatised patients whose condition necessitates mechanical ventilation of an expected duration exceeding 48h.

Ours is the first large-scale study to evaluate the interest of an innovative technology bundle on decrease of ventilator-associated pneumonia incidence in one of the intensive care populations the most at risk, namely severe trauma patients, a population presently benefiting from the other recommended preventive measures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49100
        • Sigismond LASOCKI
      • Besançon, France, 25030
        • Sébastien PILI FLOURY
      • Clermont-Ferrand, France, 63100
        • Jean Michel CONSTANTIN
      • Clichy, France, 92110
        • Catherine PAUGAM
      • Dijon, France, 21000
        • Belaid BOUHEMAD
      • Grenoble, France, 38700
        • Dominique FALCON
      • Marseille, France, 13915
        • Marc LEONE
      • Nantes, France, 44000
        • Karim ASEHNOUNE
      • Nice, France, 06000
        • Carole ICHAI
      • Nîmes, France, 30900
        • Jean Yves LEFRANT
      • Poitiers, France, 86021
        • Olivier MIMOZ
      • Rouen, France, 76031
        • Benoit VEBER
      • Strasbourg, France, 67098
        • Julien POTTECHER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients having a severe trauma as defined by an Injury Severity Score (ISS) >15,
  • Aged at least 18 years,
  • Intubated for less than 15h,
  • Necessitating recourse to mechanical ventilation for an expected period ≥ 48h,
  • Participating in a social security scheme or benefiting from such a scheme by means of a third party.

Exclusion Criteria:

  • Patient likely to die over the 48h following admission,
  • Nasotracheal intubation,
  • Patient intubated through a tracheal tube with subglottic secretion drainage
  • Intubation carried out 24h or more after the trauma,
  • Ventilation with tracheotomy,
  • Refusal to participate in the research,
  • Contraindication to the head-up position,
  • Participation in another research protocol focusing on an anti-infective treatment or on a measure decreasing the risk of infection,
  • Persons benefiting from reinforced protection or persons deprived of freedom subsequent to a legal or administrative decision, minors under legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients having developed VAP at D28 in intensive care according to the ATS definition
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients having developed VAP in ICU according to the ATS definition
Time Frame: max 60 days
max 60 days
Proportion of patients having developed early (≤ day 7) or late (> day 7) VAP in ICU according to the ATS definition
Time Frame: max 60 days
max 60 days
Time to first episode of VAP diagnosis according to the ATS definition
Time Frame: max 60 days
max 60 days
Proportion of patients developing ventilator-associated events (VAE) according to the CDC definition
Time Frame: max 60 days
max 60 days
Number of ventilator free days
Time Frame: max 60 days
max 60 days
Number of antibiotic free days
Time Frame: max 60 days
max 60 days
ICU length-of-stay
Time Frame: max 60 days
max 60 days
Proportion of patient who died during their ICU stay
Time Frame: max 60 days
max 60 days
Proportion of patients requiring corticosteroids or bronchodilators within 48 hours of tracheal extubation
Time Frame: max 60 days
max 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2015

Primary Completion (Actual)

February 15, 2018

Study Completion (Actual)

April 11, 2018

Study Registration Dates

First Submitted

July 28, 2015

First Submitted That Met QC Criteria

August 27, 2015

First Posted (Estimate)

August 28, 2015

Study Record Updates

Last Update Posted (Actual)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGATE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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