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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2011 by University Hospital, Lille.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University Hospital, Lille

ClinicalTrials.gov Identifier:

NCT01351259

First received: May 9, 2011

Last updated: NA

Last verified: April 2011

History: No changes posted

Purpose

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.

Condition	Intervention	Phase
Mechanical Ventilation Complication Tracheal Intubation Morbidity	Device: Pneumatic device, cylindrical or tapered cuff	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device

Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:

Percentage of patients with underinflation or overinflation of cuff pressure [ Time Frame: 48 h ] [ Designated as safety issue: No ]
Continuous recording of cuff pressure will be performed during 2 24-h periods (with or without the pneumatic device)

Secondary Outcome Measures:

Impact of tracheal-cuff shape on variations in cuff pressure [ Time Frame: 48 h ] [ Designated as safety issue: No ]
Patients will be intubated with cylindrical or tapered polyurethane cuffed tubes.
Impact of continuous control of cuff pressure on microaspiration of gastric contents [ Time Frame: 48 h ] [ Designated as safety issue: No ]
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 [ Time Frame: 48 h ] [ Designated as safety issue: No ]
Pepsin level in tracheal aspirates will be compared between patients intubated with cylindrical polyurethane cuffed-tubes versus those intubated with tapered polyurethane cuffed-tubes

Estimated Enrollment:	64
Study Start Date:	February 2010
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pneumatic device, tapered cuff Continuous control of cuff pressure using a pneumatic device, tapered polyurethane cuff	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 Other Names: Nosten Kimberly clark Covidien
Experimental: Pneumatic device, cylindrical cuff Continuous control of cuff pressure using a pneumatic device in patients intubated with cylindrical polyurethane cuffed tracheal tubes	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 Other Names: Nosten Kimberly clark Covidien
Active Comparator: Routine care, tapered cuff Routine care of cuff pressure using a manometer, tapered polyurethane cuff	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 Other Names: Nosten Kimberly clark Covidien
Active Comparator: Routine care, cylindrical cuff Routine care of cuff pressure using a manometer, cylindrical polyurethane tracheal cuff	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 Other Names: Nosten Kimberly clark Covidien

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351259

Contacts

Contact: Saad NSEIR, MD

33320444495

s-nseir@chru-lille.fr

Locations

France
ICU, Calmette Hospital, CHU de Lille	Recruiting
Lille, Nord, France, 59037
Contact: Saad NSEIR, MD 3320444495
Contact: Alain Durocher 33320444495 alain.durocher@chru-lille.fr
Principal Investigator: Saad NSEIR, MD
Sub-Investigator: Farid Zerimech, MD
Sub-Investigator: Malika Balduyck, MD
Sub-Investigator: Alain Durocher, MD

Sponsors and Collaborators

University Hospital, Lille

Investigators

Principal Investigator:

Saad NSEIR, MD

CHU de Lille

More Information

No publications provided

Responsible Party:	Dr. Saad NSEIR, University Hospital, Lille
ClinicalTrials.gov Identifier:	NCT01351259 History of Changes
Other Study ID Numbers:	2009-A00598-49, 2009_20/0925
Study First Received:	May 9, 2011
Last Updated:	May 9, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Lille:

Mechanical ventilation
Intubation
Cuff pressure
Microaspiration

ClinicalTrials.gov processed this record on May 22, 2013

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