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

June 9, 2015 updated by: Alexandre Boyer, Université Victor Segalen Bordeaux 2
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • CHU Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
oral/tracheal amylase ratio
Time Frame: up to 24h after bronchoscopy
up to 24h after bronchoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Victor Segalen Bordeaux 2

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

December 23, 2010

First Submitted That Met QC Criteria

December 27, 2010

First Posted (ESTIMATE)

December 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 10, 2015

Last Update Submitted That Met QC Criteria

June 9, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABoyer4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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