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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Université Victor Segalen Bordeaux 2.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Alexandre Boyer, Université Victor Segalen Bordeaux 2
ClinicalTrials.gov Identifier:
NCT01267565
First received: December 23, 2010
Last updated: June 28, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by Université Victor Segalen Bordeaux 2:

Primary Outcome Measures:
  • 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
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01267565

Contacts
Contact: Alexandre Boyer, M.D. alexandre.boyer@chu-bordeaux.fr

Locations
France
CHU Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Alexandre Boyer, M.D.       alexandre.boyer@chu-bordeaux.fr   
Principal Investigator: Alexandre Boyer, M.D.         
Sponsors and Collaborators
Université Victor Segalen Bordeaux 2
  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 October 23, 2014