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NCT01351259 Clinical Trial

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

Mechanical Ventilation Complication Clinical Trial

— Nosten  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01351259
Other study ID # 2009-A00598-49
Secondary ID 2009_20/0925
Status Completed
Phase Phase 4
First received May 9, 2011
Last updated August 31, 2013
Start date February 2010
Est. completion date September 2011

Study information
Verified date August 2013
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Pneumatic device, cylindrical or tapered cuff
Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff

Locations
Country Name City State
France ICU, Calmette Hospital, CHU de Lille Lille Nord

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients with underinflation or overinflation of cuff pressure Continuous recording of cuff pressure will be performed during 2 24-h periods (with or without the pneumatic device) 48 h No
Secondary Impact of tracheal-cuff shape on variations in cuff pressure Patients will be intubated with cylindrical or tapered polyurethane cuffed tubes. 48 h No
Secondary Impact of continuous control of cuff pressure on microaspiration of gastric contents Pepsin will be quantitatively measured in tracheal aspirates of all patients during the 2 24-h periods (with or without the pneumatic device) 48 h No
Secondary Impact of tracheal cuff shape on microaspiration of gastric contents Pepsin level in tracheal aspirates will be compared between patients intubated with cylindrical polyurethane cuffed-tubes versus those intubated with tapered polyurethane cuffed-tubes 48 h No
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