Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device
Nosten
2 other identifiers
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 9, 2011
CompletedFirst Posted
Study publicly available on registry
May 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedSeptember 4, 2013
August 1, 2013
1.6 years
May 9, 2011
August 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Impact of tracheal-cuff shape on variations in cuff pressure
48 h
Impact of continuous control of cuff pressure on microaspiration of gastric contents
48 h
Impact of tracheal cuff shape on microaspiration of gastric contents
48 h
Study Arms (4)
Pneumatic device, tapered cuff
EXPERIMENTALIntervention: continuous control of cuff pressure using a pneumatic device, tapered polyurethane cuff
Pneumatic device, cylindrical cuff
EXPERIMENTALContinuous control of cuff pressure using a pneumatic device in patients intubated with cylindrical polyurethane cuffed tracheal tubes
Routine care, tapered cuff
ACTIVE COMPARATORRoutine care of cuff pressure using a manometer, tapered polyurethane cuff
Routine care, cylindrical cuff
ACTIVE COMPARATORRoutine care of cuff pressure using a manometer, cylindrical polyurethane tracheal cuff
Interventions
Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff
Eligibility Criteria
You may qualify if:
- Patients requiring intubation in the ICU
- Predicted duration of mechanical ventilation \> or = 48h
- Age \> or = 18 years
You may not qualify if:
- Contraindication for semirecumbent position
- Contraindication for enteral nutrition
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICU, Calmette Hospital, CHU de Lille
Lille, Nord, 59037, France
Related Publications (1)
Jaillette E, Zerimech F, De Jonckheere J, Makris D, Balduyck M, Durocher A, Duhamel A, Nseir S. Efficiency of a pneumatic device in controlling cuff pressure of polyurethane-cuffed tracheal tubes: a randomized controlled study. BMC Anesthesiol. 2013 Dec 26;13(1):50. doi: 10.1186/1471-2253-13-50.
PMID: 24369057DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Saad NSEIR, MD
CHU de Lille
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
May 9, 2011
First Posted
May 10, 2011
Study Start
February 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
September 4, 2013
Record last verified: 2013-08