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

Not Applicable

Completed

• Conditions: Ventilated-acquired Pneumonia
• Interventions: Other: dosage of amylase

• Registration Number: NCT01267565
• Lead Sponsor: Université Victor Segalen Bordeaux 2

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-12-23
• Study First Submitted QC: 2010-12-27
• Study First Posted: 2010-12-28
• Primary Completion: 2011-04
• Study Completion: 2012-06
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-09
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non intubated patients	dosage of amylase	non intubated patients with an independant indication of bronchoscopy including an endotracheal aspiration during the procedure
intubated and ventilated patients	dosage of amylase	patients undergoing mechanical ventilation for an anticipated length of more than 48h

Primary Outcome Measures

Name	Time	Method
oral/tracheal amylase ratio	up to 24h after bronchoscopy

Trial Locations

Locations (1)

CHU Bordeaux; 🇫🇷 Bordeaux, France