Tracheal Dosage of Amylase : a New Surrogate for Microaspirations in Ventilated ICU Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ventilated-acquired Pneumonia |
Other: dosage of amylase |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
- oral/tracheal amylase ratio [ Time Frame: up to 24h after bronchoscopy ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | June 2012 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: intubated and ventilated patients
patients undergoing mechanical ventilation for an anticipated length of more than 48h
|
Other: dosage of amylase
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
|
|
No Intervention: non intubated patients
non intubated patients with an independant indication of bronchoscopy including an endotracheal aspiration during the procedure
|
Other: dosage of amylase
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Alexandre Boyer, M.D. | alexandre.boyer@chu-bordeaux.fr |
| France | |
| CHU Bordeaux | Recruiting |
| Bordeaux, France, 33000 | |
| Contact: Alexandre Boyer, M.D. alexandre.boyer@chu-bordeaux.fr | |
| Principal Investigator: Alexandre Boyer, M.D. | |
More Information
No publications provided
| Responsible Party: | Alexandre Boyer, M.D., Université Victor Segalen Bordeaux 2 |
| ClinicalTrials.gov Identifier: | NCT01267565 History of Changes |
| Other Study ID Numbers: | ABoyer4 |
| Study First Received: | December 23, 2010 |
| Last Updated: | June 28, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Université Victor Segalen Bordeaux 2:
|
ventilator-acquired pneumonia prevention amylase tracheal aspiration microaspiration |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 23, 2013