Balloon Palpation vs Loss of Resistance Syringe for Safe Endotracheal Tube Cuff Pressure; a Randomized Clinical Trial (LOR-ETCP)

June 29, 2015 updated by: Makerere University

Achieving Recommended Endotracheal Tube Cuff Pressure; A Randomized Control Trial Comparing Loss of Resistance Syringe to Pilot Balloon Palpation.

This study is aimed at establishing whether use of loss of resistance syringe (LOR) that is traditionally used for identifying epidural space, is a better method for providing safe cuff pressures in adults intubated with cuffed endotracheal tubes. The conventional method is the use of pilot ballon palpation (PBP) to approximate cuff pressures but this is associated with airway damage.

The study hypothesis states that both the loss of resistance syringe method and the pilot balloon palpation methods achieve the recommended endotracheal tube intracuff pressures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda, 256
        • Makerere University college of health sciences, Mulago National Referal Hospital Complex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American society of anesthesiologists (ASA) physical status classes I-IV

Exclusion Criteria:

  • Known or anticipated laryngo-tracheal abnormalities.
  • Patients with cough, sore throat, dysphagia and dysphonia.
  • Patients in whom intubation is attempted more than twice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2. LOR and aneroid manometer group
after inflating the endotracheal tube (ETT) cuff using a loss of resistance syringe (BD Epillor LOR), the LOR syringe is left attached to the pilot balloon and and any excess pressure will be passively released until the plunger stops drawing back.
Device: LOR
Other Names:
  • LOR syinge
Device: Aneroid manometer
The pilot balloon is attached onto the manometer and cuff pressures are raed off from the gauge.
Other Names:
  • VBM, Germany
Placebo Comparator: 1. PBP and aneroid manometer group
The anaesthesia care provider shall inflate the ETT cuff via the pilot balloon with small volumes of air as he/she 'feels ' for the pressures in the pilot balloon to a pressure he/she thinks is just enough. An aneroid manometer (VBM, Germany. Accurate in the range 0-120 cmH2O +-2 cmH2O) shall then be attached by the investigator and measurement of the pressure taken.
Device: Aneroid manometer
The pilot balloon is attached onto the manometer and cuff pressures are raed off from the gauge.
Other Names:
  • VBM, Germany
Device: PBP
the pilot balloon is continuously palpated o felt for adequate pressure as its being inflated.
Other Names:
  • Pilot balloon palpation technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of subjects with intracuff pressure ranging from 20cm H2O to 30cmH2O
Time Frame: 5minutes
This outcome will be measured within the first 5 minutes after intubation of the patient. The recommended range of intracuff pressure for this study is 20-30cmH2O
5minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of early postoperative airway symptoms
Time Frame: 12 hours
Patents will be reviewed 12 hours after extubation for cough, sore throat, dysphagia and dysphonia.
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makerere University

Investigators

  • Principal Investigator: Fred Bulamba, masters, Anaesthesiologist
  • Study Chair: Kintu Andrew, Fellowship, lecturer
  • Study Director: Arthur Kwizera, Masters, lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 2, 2014

First Submitted That Met QC Criteria

November 18, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Estimate)

June 30, 2015

Last Update Submitted That Met QC Criteria

June 29, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012/HD07/1766U

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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