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

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

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation With Oral Intubation
• Intervention / Treatment: Procedure: cuff pressure

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Dendermonde, Belgium, 9200
    • General Hospital Sint Blasius

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: General Hospital Sint-Blasius Dendermonde
• Investigators: Principal Investigator: Stijn Blot, PhD, Prof, University Ghent

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: December 21, 2012
• First Submitted That Met QC Criteria: December 28, 2012
• First Posted (Estimate): December 31, 2012

Study Record Updates

• Last Update Posted (Estimate): December 31, 2012
• Last Update Submitted That Met QC Criteria: December 28, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: mechanical ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2010/668