Back to resultsImpact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation
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
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
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
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
During this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage
Outcomes
Primary Outcome Measures
Cumulative incidence of pseudomonas aeruginosa presence in tracheal secretions according to the study group.
Secondary Outcome Measures
Cumulative incidence of staphylococcus aureus presence in tracheal secretions according to the study group.
Cumulative incidence of enterobacteria presence in tracheal secretions according to the study group.
Cumulative incidence of streptococcus pneumoniae presence in tracheal secretions according to the study group.
Cumulative incidence of haemophilus influenzae presence in tracheal secretions according to the study group.
Cumulative incidence of stenotrophomonas maltophilia presence in tracheal secretions according to the study group.
Cumulative incidence of acinetobacter baumannii presence in tracheal secretions according to the study group.
Cumulative incidence of other non-fermenting gram negative bacilli presence in tracheal secretions according to the study group.
Cumulative incidence of pseudomonas aeruginosa presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Cumulative incidence of staphylococcus aureus presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Cumulative incidence of enterobacteria presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Cumulative incidence of streptococcus pneumoniae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Cumulative incidence of haemophilus influenzae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Cumulative incidence of stenotrophomonas maltophilia presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Cumulative incidence of acinetobacter baumannii presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Cumulative incidence of other non-fermenting gram negative bacilli presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Full Information
NCT ID
NCT02583308
First Posted
October 20, 2015
Last Updated
March 19, 2021
Sponsor
Centre Hospitalier Departemental Vendee
Collaborators
Ministry of Health, France, University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT02583308
Brief Title
Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation
Official Title
Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation: 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
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
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
896 (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
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
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
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 (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
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
85000
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
14647884
Citation
Girou E, Buu-Hoi A, Stephan F, Novara A, Gutmann L, Safar M, Fagon JY. Airway colonisation in long-term mechanically ventilated patients. Effect of semi-recumbent position and continuous subglottic suctioning. Intensive Care Med. 2004 Feb;30(2):225-233. doi: 10.1007/s00134-003-2077-4. Epub 2003 Nov 29.
Results Reference
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Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation
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