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Effect of Body Position Changes on Endotracheal Tube Cuff Pressure in Ventilated Critically Ill Patients (CP)

Primary Purpose

Mechanical Ventilation With Oral Intubation

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
cuff pressure
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mechanical Ventilation With Oral Intubation focused on measuring mechanical ventilation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria are age 18 - 70 years, oral intubation with a taperguard EVAC endotracheal tube (Covidien®), conventional mechanical ventilation, adequate sedation (Richmond Agitation-Sedation Scale -5) and analgesia (Behavior Pain Scale 3 to 4).

Exclusion criteria are factors with potential influence on the cuff pressure or factors that disturbed the safety or well-being of the patient: pregnancy, palliative care, difficult intubation, decreased mobility of the neck, history of neck surgery, temperature of <35°C or >37.5°C, morbid obesity (body mass index >35) and every potential contra-indication for position changes such as unstable spinal cord injury or hemodynamic and/or respiratory instability.

Sites / Locations

  • General Hospital Sint Blasius

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cuff pressure after positioning

Arm Description

The patient will be positioned in 16 distinct body positions. Immediately after correct positioning, the cuff pressure is measured.

Outcomes

Primary Outcome Measures

absolute values of cuff pressure (in cm H20) an number of measurement outside target range.
Cuff pressure measurement will be executed with a universal pressure monitor.The patient will be positioned in 16 distinct body positions, immediately after correct positioning, the cuff pressure is measured during an end-expiratory ventilator hold. Cuff pressure is evaluated in the following 16 body positions: anteflexion of the head, hyperextension of the head, left lateral flexion of the head, right lateral flexion of the head, left rotation of the head, right rotation of the head, semirecumbent position with a 45° head of bed elevation, recumbent position with 10° head of bed elevation, horizontal backrest, trendelenburg 10°, left lateral position over 30°, 45° and 90°, and right lateral position over 30°, 45° and 90°.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2012
Last Updated
December 28, 2012
Sponsor
University Hospital, Ghent
Collaborators
General Hospital Sint-Blasius Dendermonde
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1. Study Identification

Unique Protocol Identification Number
NCT01757912
Brief Title
Effect of Body Position Changes on Endotracheal Tube Cuff Pressure in Ventilated Critically Ill Patients
Acronym
CP
Official Title
Effect of Body Position Changes on Endotracheal Tube Cuff Pressure in Ventilated Critically Ill Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
General Hospital Sint-Blasius Dendermonde

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The endotracheal tube secures free airway in patients undergoing surgical procedures or mechanical ventilation. The extraluminal airway needs to be sealed by a cuff. The cuff needs to be adequately inflated with air. The cuff pressure should be between 20 and 30 cm H2O. A cuff pressure in excess of the target range is associated with a risk of tracheal injury, whereas a cuff pressure below the lower limit includes a risk of micro-aspiration of subglottic secretions, with risk of subsequent ventilator-associated pneumonia. It is unknown whether the cuff pressure changes following changes in body position of the patient. The objective of this study is to investigate to which extent - if any - cuff pressures change after body position changes of the patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation With Oral Intubation
Keywords
mechanical ventilation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cuff pressure after positioning
Arm Type
Experimental
Arm Description
The patient will be positioned in 16 distinct body positions. Immediately after correct positioning, the cuff pressure is measured.
Intervention Type
Procedure
Intervention Name(s)
cuff pressure
Intervention Description
The patient will be positioned in 16 distinct body positions, immediately after correct positioning, the cuff pressure is measured during an end-expiratory ventilator hold.
Primary Outcome Measure Information:
Title
absolute values of cuff pressure (in cm H20) an number of measurement outside target range.
Description
Cuff pressure measurement will be executed with a universal pressure monitor.The patient will be positioned in 16 distinct body positions, immediately after correct positioning, the cuff pressure is measured during an end-expiratory ventilator hold. Cuff pressure is evaluated in the following 16 body positions: anteflexion of the head, hyperextension of the head, left lateral flexion of the head, right lateral flexion of the head, left rotation of the head, right rotation of the head, semirecumbent position with a 45° head of bed elevation, recumbent position with 10° head of bed elevation, horizontal backrest, trendelenburg 10°, left lateral position over 30°, 45° and 90°, and right lateral position over 30°, 45° and 90°.
Time Frame
During surgical procedure or mechanical ventilation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria are age 18 - 70 years, oral intubation with a taperguard EVAC endotracheal tube (Covidien®), conventional mechanical ventilation, adequate sedation (Richmond Agitation-Sedation Scale -5) and analgesia (Behavior Pain Scale 3 to 4). Exclusion criteria are factors with potential influence on the cuff pressure or factors that disturbed the safety or well-being of the patient: pregnancy, palliative care, difficult intubation, decreased mobility of the neck, history of neck surgery, temperature of <35°C or >37.5°C, morbid obesity (body mass index >35) and every potential contra-indication for position changes such as unstable spinal cord injury or hemodynamic and/or respiratory instability.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stijn Blot, PhD, Prof
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital Sint Blasius
City
Dendermonde
ZIP/Postal Code
9200
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Related Info

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Effect of Body Position Changes on Endotracheal Tube Cuff Pressure in Ventilated Critically Ill Patients

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