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

NCT ID: NCT01757912

Last Updated: 2012-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Mechanical Ventilation With Oral Intubation

Keywords

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mechanical ventilation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cuff pressure after positioning

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

Group Type EXPERIMENTAL

cuff pressure

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital Sint-Blasius Dendermonde

UNKNOWN

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stijn Blot, PhD, Prof

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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General Hospital Sint Blasius

Dendermonde, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Related Info

Other Identifiers

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2010/668

Identifier Type: -

Identifier Source: org_study_id