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

NCT01757912 | Completed

• 1 other identifier: 2010/668
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation With Oral Intubation

Keywords

mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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°.

  During surgical procedure or mechanical ventilation.

Study Arms (1)

Cuff pressure after positioning

EXPERIMENTAL

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

Procedure: cuff pressure

Interventions

cuff pressure PROCEDURE

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 after positioning

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• General Hospital Sint-Blasius Dendermonde: collaborator

Study Sites (1)

General Hospital Sint Blasius

Dendermonde, 9200, Belgium

Location

Related Links

• Related Info

Study Officials

• Stijn Blot, PhD, Prof

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: December 31, 2012
• Study Start: February 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 31, 2012

Record last verified: 2012-12

Locations

BE (1)