Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-02 @ 10:50 AM
Study NCT ID:
NCT01082666
Status:
COMPLETED
Last Update Posted:
2015-06-18
First Post:
2010-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients
Sponsor:
University Hospital, Lille
Organization:
Study Overview
Official Title:
Phase 4 Study of Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2009-A00431-56 | OTHER | ID-RCB number, ANSM | View |