Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients

Phase 4

Completed

• Conditions: Critically Ill
• Interventions: Device: Continuous control of cuff pressure; Device: Manual control of cuff pressure

• Registration Number: NCT01082666
• Lead Sponsor: University Hospital, Lille

Brief Summary

We hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

Detailed Description

Randomized controlled open label study, performed in a 10-bed ICU. All patients intubated with a PVC-cuffed tracheal tube and receiving enteral nutrition who require at least 48 h of mechanical ventilation are eligible. Patients receive continuous control of cuff pressure using a pneumatic device (intervention group) or manual control using a manometer (control group). Target cuff pressure is 25 cmH2O.

In all patients, pepsin is measured in tracheal aspirate during a 48-h period after inclusion, as proxy for gastric content aspiration. In addition tracheobronchial colonization and ventilator associated pneumonia rates will be compared between the two groups.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-02-05
• Study First Submitted QC: 2010-03-05
• Study First Posted: 2010-03-08
• Primary Completion: 2010-08
• Study Completion: 2010-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• age > or = 18 years
• tracheal intubation using a polyvinylchloride tube
• predictible duration of mechanical ventilation > 48 h
• enteral nutrition

Exclusion Criteria

• refuse to participate to the study
• no informed consent
• contra-indication for semirecumbment position

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous control	Continuous control of cuff pressure	Continuous control of cuff pressure using a pneumatic device
Manual control	Manual control of cuff pressure	Manual control of cuff pressure is a routine practice in ICU patients

Primary Outcome Measures

Name	Time	Method
Pepsin level in tracheal aspirate	48 h after randomization

Secondary Outcome Measures

Name	Time	Method
Ventilator-associated pneumonia, tracheobronchial colonization, tracheal ischemic lesions	day 28 after randomization

Trial Locations

Locations (1)

ICU, Calmette Hospital, University Hospital of Lille; 🇫🇷 Lille, Nord, France