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

Primary Purpose

Critically Ill

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Continuous control of cuff pressure

Manual control of cuff pressure

About this trial

This is an interventional treatment trial for Critically Ill focused on measuring Cuff pressure, microaspiration, pepsin, VAP, Mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ICU, Calmette Hospital, University Hospital of Lille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous control

Manual control

Arm Description

Continuous control of cuff pressure using a pneumatic device

Manual control of cuff pressure is a routine practice in ICU patients

Outcomes

Primary Outcome Measures

Pepsin level in tracheal aspirate

Secondary Outcome Measures

Ventilator-associated pneumonia, tracheobronchial colonization, tracheal ischemic lesions

Full Information

NCT ID

NCT01082666

First Posted

February 5, 2010

Last Updated

June 17, 2015

Sponsor

University Hospital, Lille

1. Study Identification

Unique Protocol Identification Number

NCT01082666

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critically Ill

Keywords

Cuff pressure, microaspiration, pepsin, VAP, Mechanical ventilation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Continuous control

Arm Type

Experimental

Arm Description

Continuous control of cuff pressure using a pneumatic device

Arm Title

Manual control

Arm Type

Active Comparator

Arm Description

Manual control of cuff pressure is a routine practice in ICU patients

Intervention Type

Device

Intervention Name(s)

Continuous control of cuff pressure

Other Intervention Name(s)

Automatic control of cuff pressure (Rusch, Kernen, Germany)

Intervention Description

Continuous control of cuff pressure using a pneumatic device (Nosten, Leved, France)

Intervention Type

Device

Intervention Name(s)

Manual control of cuff pressure

Other Intervention Name(s)

Manual manometer

Intervention Description

Manual control of cuff pressure is a routine practice in ICU patients

Primary Outcome Measure Information:

Title

Pepsin level in tracheal aspirate

Time Frame

48 h after randomization

Secondary Outcome Measure Information:

Title

Ventilator-associated pneumonia, tracheobronchial colonization, tracheal ischemic lesions

Time Frame

day 28 after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alain Durocher, MD

Organizational Affiliation

CHRU de Lille

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Malika Balduyck, MD

Organizational Affiliation

CHU de Lille

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Farid Zerimech, MD

Organizational Affiliation

CHU de Lille

Official's Role

Study Director

Facility Information:

Facility Name

ICU, Calmette Hospital, University Hospital of Lille

City

Lille

State/Province

Nord

ZIP/Postal Code

59037

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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