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

January 14, 2019 updated by: Centre Hospitalier Departemental Vendee

Drainage of Subglottic Secretions and Prevention of Ventilator-associated Pneumonia in Intensive carE Units: Medico-Economic Study With a Randomized clusTer and crossovER Design: DEMETER Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2577

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

  • Belgium
      • Montigny-le-Tilleul., Belgium, 6110
        • CHU André Vésale ,
  • France
      • Angoulème, France, 16959
        • CH Angoulême
      • Annecy, France, 74374
        • Ch Annecy Genevois
      • Argenteuil, France, 95100
        • Centre Hospitalier Victor Dupouy
      • Beaumont-sur-Oise, France, 95260
        • Centre Hospitalier Intercommunal des Portes de l'Oise
      • Dijon, France, 21000
        • CHU Dijon
      • La roche sur yon, France, 85000
        • CHD Vendee
      • Lens, France, 62307
        • CH Docteur Schaffner
      • Mantes la Jolie, France, 78200
        • Centre Hospitalier François Quesnay
      • Marseilels, France, 13000
        • CHU marseilles, Hôpital Nord
      • Montauban, France, 82013
        • CH de Montauban
      • Nantes, France, 44000
        • CHU Nantes
      • Orleans, France, 45067
        • Centre Hospitalier Régional D'orléans
      • Poissy, France, 78600
        • CHI Poissy Saint Germain
      • Poitiers, France, 86021
        • CHU Poitiers
      • Pontoise, France, 95303
        • Centre Hospitalier René Dubos
      • Saint Denis, France, 93200
        • Hopital DELAFONTAINE
      • Saint Nazaire, France, 44606
        • CH de SAINT NAZAIRE
      • Strasbourg, France, 67000
        • CHU de Strasbourg Nouvel Hôpital Civil
      • Strasbourg, France, 67000
        • CHU de Strasbourg Hôpital de Hautepierre
      • Tours, France, 37044
        • CHU Tours, site Bretonneau
      • Tours, France
        • CHU Tours, site Trousseau
  • Guadeloupe
      • Pointe-à-Pitre, Guadeloupe, 97159
        • CHU Pointe à Pitre les Abymes
  • Réunion
      • Saint Pierre, Réunion, 97448
        • CHU La Réunion, site de Saint Pierre de la Réunion
      • Saint-Denis, Réunion, 97405
        • CHU La Réunion, site de Saint Denis de la Réunion

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:

  • Age over 18 years
  • Invasive mechanical ventilation delivered via an endotracheal tube and expected to be required more than 24 hours
  • Intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage (SSD) will be available during the SSD period of the trial
  • Information delivered

Exclusion Criteria:

  • Previous inclusion in the study
  • Patients moribund at the ICU admission
  • Pregnant, parturient or breast-feeding woman
  • Patient hospitalized without consent and/or deprived of liberty by court's decision
  • Patient under guardianship or curators
  • Lack of social insurance
  • Concomitant inclusion in a trial on VAP prevention
  • Patient with no comprehension of the French language

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Period with endotracheal tubes not allowing SSD
During this period, patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Drainage
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
Experimental: Period with endotracheal tubes allowing SSD
During this period, patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incremental cost-utility ratio
Time Frame: 1 year after ICU admission
Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD implementation
1 year after ICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incremental cost-effectiveness ratio
Time Frame: 1 year after ICU admission
Incremental cost to gain an additional patient free of adjudicated VAP
1 year after ICU admission
Incremental cost-utility ratio (subgroup analysis)
Time Frame: 1 year after ICU admission
Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD in considering patients alive at the ICU discharge
1 year after ICU admission
Incremental cost-effectiveness ratio
Time Frame: 1 year after ICU admission
Incremental cost to gain an additional life-year
1 year after ICU admission
Budget impact analysis
Time Frame: 5 years
5 years
Microbiologically-confirmed VAP incidence
Time Frame: 90 days after the start of invasive mechanical ventilation
90 days after the start of invasive mechanical ventilation
Microbiologically-confirmed VAP density of incidence
Time Frame: 90 days after the start of invasive mechanical ventilation
90 days after the start of invasive mechanical ventilation
Defined Daily Dose of antibiotics consumption
Time Frame: Until discharge from ICU, an expected average of 12 days
Until discharge from ICU, an expected average of 12 days
Ventilator-associated Conditions incidence
Time Frame: 90 days after the start of invasive mechanical ventilation
90 days after the start of invasive mechanical ventilation
Ventilator-associated Conditions density of incidence
Time Frame: 90 days after the start of invasive mechanical ventilation
90 days after the start of invasive mechanical ventilation
Infection related Ventilator-associated Conditions incidence
Time Frame: 90 days after the start of invasive mechanical ventilation
90 days after the start of invasive mechanical ventilation
Duration of invasive mechanical ventilation
Time Frame: Until weaning of mechanical ventilation, an expected average of 10 days
Until weaning of mechanical ventilation, an expected average of 10 days
Ventilator-free days
Time Frame: 90 days after the start of invasive mechanical ventilation
90 days after the start of invasive mechanical ventilation
ICU length of stay
Time Frame: Until discharge from ICU, an expected average of 12 days
Until discharge from ICU, an expected average of 12 days
Hospital length of stay
Time Frame: Until discharge from hospital, an expected average of 20 days
Until discharge from hospital, an expected average of 20 days
ICU mortality
Time Frame: Until discharge from ICU, an expected average of 12 days
Until discharge from ICU, an expected average of 12 days
90-days mortality
Time Frame: 90 days after ICU admission
90 days after ICU admission
180-days mortality
Time Frame: 180 days after ICU admission
180 days after ICU admission
1 year mortality
Time Frame: 1 year after ICU admission
1 year after ICU admission
Post-extubation laryngo-tracheal dyspnea incidence
Time Frame: Until weaning of mechanical ventilation,, an expected average of 10 days
Until weaning of mechanical ventilation,, an expected average of 10 days

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Departemental Vendee

Collaborators

Ministry of Health, France
University Hospital, Tours
URC Eco Ile de France

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)

November 5, 2015

Primary Completion (Actual)

November 22, 2018

Study Completion (Actual)

November 22, 2018

Study Registration Dates

First Submitted

July 31, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimate)

August 5, 2015

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD 045-14

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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