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Medico-economic Study of the Subglottic Secretions Drainage in Prevention of Ventilator-associated Pneumonia (DEMETER)

NCT02515617 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2577

Last updated 2019-01-15

No results posted yet for this study

Summary

In France, despite the implementation of bundles to prevent Ventilator-Associated Pneumonia (VAP) in the last decades, the VAP incidence remains high above 10 per cent. In the last american recommendations of VAP prevention, the drainage of subglottic secretions (SSD) has been notified among the "basic practices" to prevent VAP. Nevertheless, the diffusion of SSD in ICUs remains limited. This situation is largely due to the initial overcost of the specific endotracheal tubes allowing SSD and to the unavailability of these devices in medical units in which patients are intubated before the ICU admission. So, this pragmatical cluster randomized and cross-over study evaluates the medico-economic impact of the subglottic secretions drainage in addition to VAP prevention bundles in ICU.

Conditions

  • Ventilator-associated Pneumonia

Interventions

DEVICE

Endotracheal tubes not allowing SSD

In each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure

DEVICE

Endotracheal tubes allowing SSD

In each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure. In addition, SSD will be realized using a 10 ml syringe at in attending frequency of 2 hours.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • URC Eco Ile de France

    collaborator UNKNOWN

  • University Hospital, Tours

    collaborator OTHER

  • Centre Hospitalier Departemental Vendee

    lead OTHER

Principal Investigators

  • Jean-Claude LACHERADE, MD · CHD VENDEE

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-05
Primary Completion
2018-11-22
Completion
2018-11-22

Countries

  • Belgium
  • France
  • Guadeloupe
  • Reunion

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02515617 on ClinicalTrials.gov