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

Not Applicable

Completed

• Conditions: Mechanical Ventilation With Oral Intubation
• Interventions: Procedure: cuff pressure

• Registration Number: NCT01757912
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-12
• Study First Submitted: 2012-12-21
• Study First Submitted QC: 2012-12-28
• Last Update Submitted: 2012-12-28
• Study First Posted: 2012-12-31
• Last Update Posted: 2012-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
absolute values of cuff pressure (in cm H20) an number of measurement outside target range.	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°.

Trial Locations

Locations (1)

General Hospital Sint Blasius; 🇧🇪 Dendermonde, Belgium