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

NCT01267565 | Completed

• 1 other identifier: ABoyer4
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilated-acquired Pneumonia

Keywords

ventilator-acquired pneumonia; prevention; amylase; tracheal aspiration; microaspiration

Outcome Measures

Primary Outcomes (1)

• oral/tracheal amylase ratio

  up to 24h after bronchoscopy

Study Arms (2)

intubated and ventilated patients

OTHER

patients undergoing mechanical ventilation for an anticipated length of more than 48h

Other: dosage of amylase

non intubated patients

OTHER

non intubated patients with an independant indication of bronchoscopy including an endotracheal aspiration during the procedure

Other: dosage of amylase

Interventions

dosage of amylase OTHER

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

intubated and ventilated patients; non intubated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients ventilated for less than 48h
• 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.

Sponsors & Collaborators

• Université Victor Segalen Bordeaux 2: lead

Study Sites (1)

CHU Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: December 28, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2012
• Last Updated: June 10, 2015

Record last verified: 2015-06

Locations

FR (1)