Clinical Trials Directory

Trials / Completed

CompletedNCT01267565

Tracheal Dosage of Amylase : a New Surrogate for Microaspirations in Ventilated ICU Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Université Victor Segalen Bordeaux 2 · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERdosage of amylase4 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

Timeline

Start date
2010-09-01
Primary completion
2011-04-01
Completion
2012-06-01
First posted
2010-12-28
Last updated
2015-06-10

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01267565. Inclusion in this directory is not an endorsement.