Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation

March 19, 2021 updated by: Centre Hospitalier Departemental Vendee

Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation: an Ancillary Study of the DEMETER Trial (NCT02515617)

Meta-analysis provide evidence for the benefit of the subglottic secretions drainage (SSD) to reduce the occurrence of Ventilator-Associated Pneumonia (VAP). Nevertheless, the diagnosis of VAP is widely considered as subjective and prone to both false-positive and false negative assignments. In ths way, the impact of SSD remains controversial and its use limited in Intensive Care Units. The DEMETER study assessing the medico-economical impact of the the subglottic secretions drainage (NCT02515617) provides the opportunity to evaluate the dynamics of tracheal colonisation with and without the realisation of SSD. This evaluation would reinforce the results observed during the DEMETER study in considering the adjudicated VAP incidence.

This ancillary study will be performed in 14 centers participating to the DEMETER study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

896

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 Andre VESALE
  • France
      • 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
      • La Roche sur Yon, France, 85000
        • CHD Vendee
      • Lens, France, 62307
        • CH Docteur Schaffner
      • Montauban, France, 82013
        • CH de Montauban
      • Orleans, France, 45067
        • Centre Hospitalier Régional D'orléans
      • Pointe-à-Pitre, France, 97159
        • CHU Pointe-à-Pitre les Abymes
      • Poissy, France, 78600
        • CHI Poissy Saint Germain
      • Pontoise, France, 95303
        • Centre Hospitalier René Dubos
      • Saint Nazaire, France, 44606
        • CH de SAINT NAZAIRE
      • Saint-Denis (Réunion), France, 97405
        • CHU La Réunion, site de Saint Denis de la Réunion
      • Strasbourg, France, 67000
        • CHU de Strasbourg Nouvel Hôpital Civil
      • Tours, France, 37044
        • CHU Tours, site Bretonneau

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 Intensive Care Unit 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Period with endotracheal tubes not allowing SSD
During this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions
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 of the DEMETER study (NCT02515617), 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
Time Frame
Cumulative incidence of pseudomonas aeruginosa presence in tracheal secretions according to the study group.
Time Frame: Until weaning of mechanical ventilation, an expected average of 10 days
Until weaning of mechanical ventilation, an expected average of 10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Cumulative incidence of staphylococcus aureus presence in tracheal secretions according to the study group.
Time Frame: Until weaning of mechanical ventilation, an expected average of 10 days
Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of enterobacteria presence in tracheal secretions according to the study group.
Time Frame: Until weaning of mechanical ventilation, an expected average of 10 days
Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of streptococcus pneumoniae presence in tracheal secretions according to the study group.
Time Frame: Until weaning of mechanical ventilation, an expected average of 10 days
Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of haemophilus influenzae presence in tracheal secretions according to the study group.
Time Frame: Until weaning of mechanical ventilation, an expected average of 10 days
Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of stenotrophomonas maltophilia presence in tracheal secretions according to the study group.
Time Frame: Until weaning of mechanical ventilation, an expected average of 10 days
Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of acinetobacter baumannii presence in tracheal secretions according to the study group.
Time Frame: Until weaning of mechanical ventilation, an expected average of 10 days
Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of other non-fermenting gram negative bacilli presence in tracheal secretions according to the study group.
Time Frame: Until weaning of mechanical ventilation, an expected average of 10 days
Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of pseudomonas aeruginosa presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time Frame: Until weaning of mechanical ventilation, an expected average of 10 days
Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of staphylococcus aureus presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time Frame: Until weaning of mechanical ventilation, an expected average of 10 days
Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of enterobacteria presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time Frame: Until weaning of mechanical ventilation, an expected average of 10 days
Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of streptococcus pneumoniae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time Frame: Until weaning of mechanical ventilation, an expected average of 10 days
Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of haemophilus influenzae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time Frame: Until weaning of mechanical ventilation, an expected average of 10 days
Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of stenotrophomonas maltophilia presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time Frame: Until weaning of mechanical ventilation, an expected average of 10 days
Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of acinetobacter baumannii presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time Frame: Until weaning of mechanical ventilation, an expected average of 10 days
Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of other non-fermenting gram negative bacilli presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
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

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 4, 2015

Primary Completion (Actual)

November 29, 2017

Study Completion (Actual)

November 29, 2017

Study Registration Dates

First Submitted

October 20, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD 053-15

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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