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

This study has been completed.
Sponsor:
Collaborator:
General Hospital Sint-Blasius Dendermonde
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01757912
First received: December 21, 2012
Last updated: December 28, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Mechanical Ventilation With Oral Intubation
Procedure: cuff pressure

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effect of Body Position Changes on Endotracheal Tube Cuff Pressure in Ventilated Critically Ill Patients.

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • absolute values of cuff pressure (in cm H20) an number of measurement outside target range. [ Time Frame: During surgical procedure or mechanical ventilation. ] [ Designated as safety issue: Yes ]
    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°.


Enrollment: 12
Study Start Date: February 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cuff pressure after positioning
The patient will be positioned in 16 distinct body positions. Immediately after correct positioning, the cuff pressure is measured.
Procedure: cuff pressure
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01757912

Locations
Belgium
General Hospital Sint Blasius
Dendermonde, Belgium, 9200
Sponsors and Collaborators
University Hospital, Ghent
General Hospital Sint-Blasius Dendermonde
Investigators
Principal Investigator: Stijn Blot, PhD, Prof University Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01757912     History of Changes
Other Study ID Numbers: 2010/668
Study First Received: December 21, 2012
Last Updated: December 28, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
mechanical ventilation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014