Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device

Phase 4

Completed

• Conditions: Mechanical Ventilation Complication; Tracheal Intubation Morbidity
• Interventions: Device: Pneumatic device, cylindrical or tapered cuff

• Registration Number: NCT01351259
• Lead Sponsor: University Hospital, Lille

Brief Summary

Underinflation and overinflation of tracheal cuff are common in intubated patients, including those intubated with polyurethane-cuffed tubes. The aim of this study is to determine the efficiency of a pneumatic device in controlling cuff pressure.

Detailed Description

Underinflation and overinflation of tracheal cuff are associated with severe complications such as microaspiration of contaminated secretions, and tracheal ischemia. Efficient control of cuff pressure would probably allow reducing complications related to variations in cuff pressure.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-31
• Last Update Posted: 2013-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Patients requiring intubation in the ICU
• Predicted duration of mechanical ventilation > or = 48h
• Age > or = 18 years

Exclusion Criteria

• Contraindication for semirecumbent position
• Contraindication for enteral nutrition
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pneumatic device, tapered cuff	Pneumatic device, cylindrical or tapered cuff	Intervention: continuous control of cuff pressure using a pneumatic device, tapered polyurethane cuff
Pneumatic device, cylindrical cuff	Pneumatic device, cylindrical or tapered cuff	Continuous control of cuff pressure using a pneumatic device in patients intubated with cylindrical polyurethane cuffed tracheal tubes
Routine care, tapered cuff	Pneumatic device, cylindrical or tapered cuff	Routine care of cuff pressure using a manometer, tapered polyurethane cuff
Routine care, cylindrical cuff	Pneumatic device, cylindrical or tapered cuff	Routine care of cuff pressure using a manometer, cylindrical polyurethane tracheal cuff

Primary Outcome Measures

Name	Time	Method
Percentage of patients with underinflation or overinflation of cuff pressure	48 h	Continuous recording of cuff pressure will be performed during 2 24-h periods (with or without the pneumatic device)

Secondary Outcome Measures

Name	Time	Method
Impact of tracheal-cuff shape on variations in cuff pressure	48 h	Patients will be intubated with cylindrical or tapered polyurethane cuffed tubes.
Impact of continuous control of cuff pressure on microaspiration of gastric contents	48 h	Pepsin will be quantitatively measured in tracheal aspirates of all patients during the 2 24-h periods (with or without the pneumatic device)
Impact of tracheal cuff shape on microaspiration of gastric contents	48 h	Pepsin level in tracheal aspirates will be compared between patients intubated with cylindrical polyurethane cuffed-tubes versus those intubated with tapered polyurethane cuffed-tubes

Trial Locations

Locations (1)

ICU, Calmette Hospital, CHU de Lille; 🇫🇷 Lille, Nord, France