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Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia

Primary Purpose

Ventilator-associated Pneumonia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Endotracheal tubes not allowing SSD
Endotracheal tubes allowing SSD
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilator-associated Pneumonia focused on measuring Ventilator-associated pneumonia, Surveillance, Subglottic-secretions, Critically ill patients, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • CHU André Vésale
  • CH Annecy Genevois
  • Centre Hospitalier Victor Dupouy
  • Centre Hospitalier Intercommunal des Portes de l'Oise
  • Chd Vendee
  • CH Docteur Schaffner
  • CH de Montauban
  • Centre Hospitalier Régional d'Orléans
  • CHU Pointe à Pitre les Abymes
  • CHI Poissy Saint Germain
  • Centre Hospitalier René Dubos
  • CH de Saint Nazaire
  • CHU La Réunion, site de Saint Denis de la Réunion
  • CHU de Strasbourg Nouvel Hôpital Civil
  • CHU Tours, site Bretonneau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Period with endotracheal tubes not allowing SSD

Period with endotracheal tubes allowing SSD

Arm Description

During this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Drainage

During this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage

Outcomes

Primary Outcome Measures

Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the subglottic secretions culture surveillance.
For each episode of VAP, bacteria involved will be compared with bacteria isolated, previously, into the subglottic secretions. This comparison will be performed by the microbiologist of each center. A bacteria isolated into the subglottic secretions will be considered as the same than the one involved in VAP if these 2 same micro-organisms have the same antibiotics susceptibility. Moreover, for the comparison, the third last subglottic secretions samples, if available, obtained before the VAP occurrence, will be taking account.

Secondary Outcome Measures

Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the tracheal secretions culture surveillance.
For each episode of VAP, bacteria involved will be compared with bacteria isolated, previously, into the tracheal secretions. This comparison will be performed by the microbiologist of each center. A bacteria isolated into the tracheal secretions will be considered as the same than the one involved in VAP if these 2 same microorganisms have the same antibiotics susceptibility. Moreover, for the comparison, the third last tracheal secretions samples, if available, obtained before the VAP occurrence will be taking account.
Adequate probabilistic antibiotherapy initiated during the study by the investigators in case of adjudicated VAP
Proportion of VAP for whom the probabilistic antibiotherapy used during the trial appeared to be empirically active
Adequate theoretical probabilistic antibiotherapy with the knowledge of the subglottic culture surveillance
Proportion of adjudicated VAP for whom a theoretical probabilistic antibiotherapy would be empirically active with the knowledge of the results of the subglottic secretions samples obtained more than 3 days before the occurrence of VAP. The theoretical antibiotherapy will be determined by an independent committee unaware of the type of samples evaluated (subglottic or tracheal secretions).
Adequate theoretical probabilistic antibiotherapy with the knowledge of the tracheal culture surveillance
Proportion of adjudicated VAP for whom a theoretical probabilistic antibiotherapy would be empirically active with the knowledge of the results of the tracheal secretions samples obtained more than 3 days before the occurrence of VAP. The theoretical antibiotherapy will be determined by an independent committee unaware of the type of samples evaluated (subglottic or tracheal secretions).

Full Information

First Posted
October 20, 2015
Last Updated
March 19, 2021
Sponsor
Centre Hospitalier Departemental Vendee
Collaborators
Ministry of Health, France, University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02585180
Brief Title
Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia
Official Title
Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia (VAP): an Ancillary Study of the DEMETER Trial (NCT02515617)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 4, 2015 (Actual)
Primary Completion Date
November 29, 2017 (Actual)
Study Completion Date
November 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
Collaborators
Ministry of Health, France, University Hospital, Tours

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Many studies provide evidence for the benefit of lower respiratory tract surveillance, mostly by culture of endotracheal secretions, to predict bacterial pathogens (especially multi-drugs resistant pathogens) involved in VAP. The DEMETER study (NCT02515617) assessing the medico-economical impact of the subglottic secretions drainage (SSD) provides the opportunity to evaluate the accuracy of the subglottic secretions culture surveillance to predict pathogens involved in VAP (in comparison with the concomitant endotracheal secretions surveillance). These subglottic and tracheal secretions culture surveillance will be masked to the investigators of the DEMETER Study. This ancillary study will be performed in 14 centers participating to the DEMETER study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-associated Pneumonia
Keywords
Ventilator-associated pneumonia, Surveillance, Subglottic-secretions, Critically ill patients, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Period with endotracheal tubes not allowing SSD
Arm Type
Active Comparator
Arm Description
During this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Drainage
Arm Title
Period with endotracheal tubes allowing SSD
Arm Type
Experimental
Arm Description
During this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage
Intervention Type
Device
Intervention Name(s)
Endotracheal tubes not allowing SSD
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Endotracheal tubes allowing SSD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the subglottic secretions culture surveillance.
Description
For each episode of VAP, bacteria involved will be compared with bacteria isolated, previously, into the subglottic secretions. This comparison will be performed by the microbiologist of each center. A bacteria isolated into the subglottic secretions will be considered as the same than the one involved in VAP if these 2 same micro-organisms have the same antibiotics susceptibility. Moreover, for the comparison, the third last subglottic secretions samples, if available, obtained before the VAP occurrence, will be taking account.
Time Frame
Until weaning of mechanical ventilation, an expected average of 10 days
Secondary Outcome Measure Information:
Title
Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the tracheal secretions culture surveillance.
Description
For each episode of VAP, bacteria involved will be compared with bacteria isolated, previously, into the tracheal secretions. This comparison will be performed by the microbiologist of each center. A bacteria isolated into the tracheal secretions will be considered as the same than the one involved in VAP if these 2 same microorganisms have the same antibiotics susceptibility. Moreover, for the comparison, the third last tracheal secretions samples, if available, obtained before the VAP occurrence will be taking account.
Time Frame
Until weaning of mechanical ventilation, an expected average of 10 days
Title
Adequate probabilistic antibiotherapy initiated during the study by the investigators in case of adjudicated VAP
Description
Proportion of VAP for whom the probabilistic antibiotherapy used during the trial appeared to be empirically active
Time Frame
Until weaning of mechanical ventilation, an expected average of 10 days
Title
Adequate theoretical probabilistic antibiotherapy with the knowledge of the subglottic culture surveillance
Description
Proportion of adjudicated VAP for whom a theoretical probabilistic antibiotherapy would be empirically active with the knowledge of the results of the subglottic secretions samples obtained more than 3 days before the occurrence of VAP. The theoretical antibiotherapy will be determined by an independent committee unaware of the type of samples evaluated (subglottic or tracheal secretions).
Time Frame
Until weaning of mechanical ventilation, an expected average of 10 days
Title
Adequate theoretical probabilistic antibiotherapy with the knowledge of the tracheal culture surveillance
Description
Proportion of adjudicated VAP for whom a theoretical probabilistic antibiotherapy would be empirically active with the knowledge of the results of the tracheal secretions samples obtained more than 3 days before the occurrence of VAP. The theoretical antibiotherapy will be determined by an independent committee unaware of the type of samples evaluated (subglottic or tracheal secretions).
Time Frame
Until weaning of mechanical ventilation, an expected average of 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Claude LACHERADE, MD
Organizational Affiliation
CHD VENDEE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU André Vésale
City
Montigny-le-Tilleul.
ZIP/Postal Code
6110
Country
Belgium
Facility Name
CH Annecy Genevois
City
Annecy
ZIP/Postal Code
74374
Country
France
Facility Name
Centre Hospitalier Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
Centre Hospitalier Intercommunal des Portes de l'Oise
City
Beaumont-sur-Oise
ZIP/Postal Code
95260
Country
France
Facility Name
Chd Vendee
City
La roche sur yon
ZIP/Postal Code
85170
Country
France
Facility Name
CH Docteur Schaffner
City
Lens
ZIP/Postal Code
62307
Country
France
Facility Name
CH de Montauban
City
Montauban
ZIP/Postal Code
82013
Country
France
Facility Name
Centre Hospitalier Régional d'Orléans
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
CHU Pointe à Pitre les Abymes
City
Pointe-à-Pitre
ZIP/Postal Code
97159
Country
France
Facility Name
CHI Poissy Saint Germain
City
Poissy
ZIP/Postal Code
78600
Country
France
Facility Name
Centre Hospitalier René Dubos
City
Pontoise
ZIP/Postal Code
95303
Country
France
Facility Name
CH de Saint Nazaire
City
Saint Nazaire
ZIP/Postal Code
44606
Country
France
Facility Name
CHU La Réunion, site de Saint Denis de la Réunion
City
Saint-Denis (Réunion)
ZIP/Postal Code
97405
Country
France
Facility Name
CHU de Strasbourg Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
CHU Tours, site Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23188467
Citation
Brusselaers N, Labeau S, Vogelaers D, Blot S. Value of lower respiratory tract surveillance cultures to predict bacterial pathogens in ventilator-associated pneumonia: systematic review and diagnostic test accuracy meta-analysis. Intensive Care Med. 2013 Mar;39(3):365-75. doi: 10.1007/s00134-012-2759-x. Epub 2012 Nov 28.
Results Reference
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Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia

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