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

University Hospital, Lille

Status and phase: Completed; Phase 4

Conditions: Mechanical Ventilation Complication; Tracheal Intubation Morbidity

Treatments: Device: Pneumatic device, cylindrical or tapered cuff

Study type: Interventional

Funder types: Other

Identifiers

NCT01351259

2009_20/0925 (Other Identifier)

2009-A00598-49

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 4 patient groups

Pneumatic device, tapered cuff

Experimental group

Description:

Intervention: continuous control of cuff pressure using a pneumatic device, tapered polyurethane cuff

Treatment:

Device: Pneumatic device, cylindrical or tapered cuff

Pneumatic device, cylindrical cuff

Experimental group

Description:

Continuous control of cuff pressure using a pneumatic device in patients intubated with cylindrical polyurethane cuffed tracheal tubes

Treatment:

Device: Pneumatic device, cylindrical or tapered cuff

Routine care, tapered cuff

Active Comparator group

Description:

Routine care of cuff pressure using a manometer, tapered polyurethane cuff

Treatment:

Device: Pneumatic device, cylindrical or tapered cuff

Routine care, cylindrical cuff

Active Comparator group

Description:

Routine care of cuff pressure using a manometer, cylindrical polyurethane tracheal cuff

Treatment:

Device: Pneumatic device, cylindrical or tapered cuff