Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients
This study has been completed.
Sponsor:
University Hospital, Lille
Information provided by:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01082666
First received: February 5, 2010
Last updated: May 31, 2011
Last verified: December 2009
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Purpose
We hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.
| Condition | Intervention | Phase |
|---|---|---|
|
Critically Ill |
Device: Continuous control of cuff pressure Device: Manual control of cuff pressure |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase 4 Study of Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients |
Further study details as provided by University Hospital, Lille:
Primary Outcome Measures:
- Pepsin level in tracheal aspirate [ Time Frame: 48 h after randomization ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Ventilator-associated pneumonia, tracheobronchial colonization, tracheal ischemic lesions [ Time Frame: day 28 after randomization ] [ Designated as safety issue: No ]
| Enrollment: | 122 |
| Study Start Date: | October 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Continuous control
Continuous control of cuff pressure using a pneumatic device
|
Device: Continuous control of cuff pressure
Continuous control of cuff pressure using a pneumatic device (Nosten, Leved, France)
Other Name: Automatic control of cuff pressure (Rusch, Kernen, Germany)
|
|
Active Comparator: Manual control
Manual control of cuff pressure is a routine practice in ICU patients
|
Device: Manual control of cuff pressure
Manual control of cuff pressure is a routine practice in ICU patients
Other Name: Manual manometer
|
Detailed Description:
Randomized controlled open label study, performed in a 10-bed ICU. All patients intubated with a PVC-cuffed tracheal tube and receiving enteral nutrition who require at least 48 h of mechanical ventilation are eligible. Patients receive continuous control of cuff pressure using a pneumatic device (intervention group) or manual control using a manometer (control group). Target cuff pressure is 25 cmH2O.
In all patients, pepsin is measured in tracheal aspirate during a 48-h period after inclusion, as proxy for gastric content aspiration. In addition tracheobronchial colonization and ventilator associated pneumonia rates will be compared between the two groups.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age > or = 18 years
- tracheal intubation using a polyvinylchloride tube
- predictible duration of mechanical ventilation > 48 h
- enteral nutrition
Exclusion Criteria:
- refuse to participate to the study
- no informed consent
- contra-indication for semirecumbment position
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082666
Locations
| France | |
| ICU, Calmette Hospital, University Hospital of Lille | |
| Lille, Nord, France, 59037 | |
Sponsors and Collaborators
University Hospital, Lille
Investigators
| Study Director: | Alain Durocher, MD | CHRU de Lille |
| Study Director: | Malika Balduyck, MD | CHU de Lille |
| Study Director: | Farid Zerimech, MD | CHU de Lille |
More Information
No publications provided
| Responsible Party: | Saad NSEIR, MD, University Hospital, Lille |
| ClinicalTrials.gov Identifier: | NCT01082666 History of Changes |
| Other Study ID Numbers: | 2009-A00431-56, 2008_53/0919 |
| Study First Received: | February 5, 2010 |
| Last Updated: | May 31, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Lille:
|
Cuff pressure microaspiration pepsin VAP Mechanical ventilation |
Additional relevant MeSH terms:
|
Critical Illness Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013