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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2577

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Angoulème
      • 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 Rene Dubos
      • Saint Denis, France, 93200
        • Hôpital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Departemental Vendee

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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