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NCT01082666 Clinical Trial

Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients

Critically Ill Clinical Trial

Official title:
Phase 4 Study of Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01082666
Other study ID # 2008_53/0919
Secondary ID 2009-A00431-56
Status Completed
Phase Phase 4
First received February 5, 2010
Last updated June 17, 2015
Start date October 2009
Est. completion date December 2010

Study information
Verified date June 2015
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

We hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

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.

Recruitment information / eligibility
Status Completed
Enrollment 122
Est. completion date December 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Continuous control of cuff pressure
Continuous control of cuff pressure using a pneumatic device (Nosten, Leved, France)
• Manual control of cuff pressure
Manual control of cuff pressure is a routine practice in ICU patients

Locations
Country Name City State
France ICU, Calmette Hospital, University Hospital of Lille Lille Nord

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pepsin level in tracheal aspirate 48 h after randomization No
Secondary Ventilator-associated pneumonia, tracheobronchial colonization, tracheal ischemic lesions day 28 after randomization No
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