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

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ClinicalTrials.gov Identifier: NCT01757912
Recruitment Status : Completed
First Posted : December 31, 2012
Last Update Posted : December 31, 2012
Sponsor:
Collaborator:
General Hospital Sint-Blasius Dendermonde
Information provided by (Responsible Party):
University Hospital, Ghent

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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation With Oral Intubation Procedure: cuff pressure Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of Body Position Changes on Endotracheal Tube Cuff Pressure in Ventilated Critically Ill Patients.
Study Start Date : February 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01757912     History of Changes
Other Study ID Numbers: 2010/668
First Posted: December 31, 2012    Key Record Dates
Last Update Posted: December 31, 2012
Last Verified: December 2012

Keywords provided by University Hospital, Ghent:
mechanical ventilation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes