Tracheal Dosage of Amylase : a New Surrogate for Microaspirations in Ventilated ICU Patients
Primary Purpose
Ventilated-acquired Pneumonia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
dosage of amylase
Sponsored by
About this trial
This is an interventional diagnostic trial for Ventilated-acquired Pneumonia focused on measuring ventilator-acquired pneumonia, prevention, amylase, tracheal aspiration, microaspiration
Eligibility Criteria
Inclusion Criteria:
- intubated and ventlated patients group: patients ventilated with a tube including a subglottic secretion device for an anticipated length > 48h and producing sufficient endotracheal aspirations
- non intubated patients group: patients with an study-independant indication to bronchoscopy and necessitating a tracheal aspiration during the procedure
Exclusion Criteria:
- patients ventilated for less than 48h
- patients developing ventilated-acquired pneumonia or bronchitis before potential inclusion
- paralysed patients
- patients requiring a closed suction device
- patients with relative contraindications to endotracheal aspiration (status asthmaticus, severe ARDS with PF ratio < 100, hemorragic risk, brochopleural fistula)
- bronchiectasis, cystic fibrosis
- moribund patient or ethical decision to withhold or withdraw intensive care.
Sites / Locations
- CHU Bordeaux
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
intubated and ventilated patients
non intubated patients
Arm Description
patients undergoing mechanical ventilation for an anticipated length of more than 48h
non intubated patients with an independant indication of bronchoscopy including an endotracheal aspiration during the procedure
Outcomes
Primary Outcome Measures
oral/tracheal amylase ratio
Secondary Outcome Measures
Full Information
NCT ID
NCT01267565
First Posted
December 23, 2010
Last Updated
June 9, 2015
Sponsor
Université Victor Segalen Bordeaux 2
1. Study Identification
Unique Protocol Identification Number
NCT01267565
Brief Title
Tracheal Dosage of Amylase : a New Surrogate for Microaspirations in Ventilated ICU Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Victor Segalen Bordeaux 2
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Microaspirations of the oropharyngeal ± gastric contents through the endotracheal tube cuff contribute to the constitution of VAP. The pepsin has been recently proved effective as a surrogate of gastric content and was assessed in tracheal secretions. However, the pepsin dosage is fastidious, expensive and only characterizes aspirations from gastric origin. The aim of our study is to asses whether the value of amylase, which is mostly secreted by salivary glands, may turn out to be a new and simpler surrogate for microaspirations in ventilated ICU patients. Thirty patients ventilated for an anticipated length > 48h whose endotracheal tube includes a subglottic secretion device and producing sufficient endotracheal aspirations will be included. From H48, 4 sets of 3 aspirations each (oral, subglottic, tracheal) will be performed during one ventilation day for amylase dosage purpose. In ten of these patients, a comparison between pepsin and amylase will be assessed. In addition, 10 non intubated patients with an indication to bronchoscopy and necessitating a tracheal aspiration during the procedure will be included as a control group. The primary assessment criteria will be the oral/tracheal amylase ratio.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilated-acquired Pneumonia
Keywords
ventilator-acquired pneumonia, prevention, amylase, tracheal aspiration, microaspiration
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intubated and ventilated patients
Arm Type
Other
Arm Description
patients undergoing mechanical ventilation for an anticipated length of more than 48h
Arm Title
non intubated patients
Arm Type
Other
Arm Description
non intubated patients with an independant indication of bronchoscopy including an endotracheal aspiration during the procedure
Intervention Type
Other
Intervention Name(s)
dosage of amylase
Intervention Description
4 sets of aspirations on one day per inclusion in the intubated and ventilated patients group and 1 set of aspiration in the non intubated patients group
Primary Outcome Measure Information:
Title
oral/tracheal amylase ratio
Time Frame
up to 24h after bronchoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
intubated and ventlated patients group: patients ventilated with a tube including a subglottic secretion device for an anticipated length > 48h and producing sufficient endotracheal aspirations
non intubated patients group: patients with an study-independant indication to bronchoscopy and necessitating a tracheal aspiration during the procedure
Exclusion Criteria:
patients ventilated for less than 48h
patients developing ventilated-acquired pneumonia or bronchitis before potential inclusion
paralysed patients
patients requiring a closed suction device
patients with relative contraindications to endotracheal aspiration (status asthmaticus, severe ARDS with PF ratio < 100, hemorragic risk, brochopleural fistula)
bronchiectasis, cystic fibrosis
moribund patient or ethical decision to withhold or withdraw intensive care.
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
12. IPD Sharing Statement
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Tracheal Dosage of Amylase : a New Surrogate for Microaspirations in Ventilated ICU Patients
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