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

Université Victor Segalen Bordeaux 2

Status: Completed

Conditions: Ventilated-acquired Pneumonia

Treatments: Other: dosage of amylase

Study type: Interventional

Funder types: Other

Identifiers

NCT01267565

ABoyer4

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

intubated and ventilated patients

Other group

Description:

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

Treatment:

Other: dosage of amylase

non intubated patients

Other group

Description:

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

Treatment:

Other: dosage of amylase