Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients
Phase 4 Study of Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients
2 other identifiers
interventional
122
1 country
1
Brief Summary
We hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2009
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
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 5, 2010
CompletedFirst Posted
Study publicly available on registry
March 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedApril 22, 2026
June 1, 2015
10 months
February 5, 2010
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pepsin level in tracheal aspirate
48 h after randomization
Secondary Outcomes (1)
Ventilator-associated pneumonia, tracheobronchial colonization, tracheal ischemic lesions
day 28 after randomization
Study Arms (2)
Continuous control
EXPERIMENTALContinuous control of cuff pressure using a pneumatic device
Manual control
ACTIVE COMPARATORManual control of cuff pressure is a routine practice in ICU patients
Interventions
Continuous control of cuff pressure using a pneumatic device (Nosten, Leved, France)
Manual control of cuff pressure is a routine practice in ICU patients
Eligibility Criteria
You may qualify if:
- age \> or = 18 years
- tracheal intubation using a polyvinylchloride tube
- predictible duration of mechanical ventilation \> 48 h
- enteral nutrition
You may not qualify if:
- refuse to participate to the study
- no informed consent
- contra-indication for semirecumbment position
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICU, Calmette Hospital, University Hospital of Lille
Lille, Nord, 59037, France
Related Publications (1)
Nseir S, Zerimech F, Fournier C, Lubret R, Ramon P, Durocher A, Balduyck M. Continuous control of tracheal cuff pressure and microaspiration of gastric contents in critically ill patients. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1041-7. doi: 10.1164/rccm.201104-0630OC.
PMID: 21836137RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alain Durocher, MD
CHRU de Lille
- STUDY DIRECTOR
Malika Balduyck, MD
CHU de Lille
- STUDY DIRECTOR
Farid Zerimech, MD
CHU de Lille
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2010
First Posted
March 8, 2010
Study Start
October 1, 2009
Primary Completion
August 1, 2010
Study Completion
December 1, 2010
Last Updated
April 22, 2026
Record last verified: 2015-06