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Balloon Palpation vs Loss of Resistance Syringe for Safe Endotracheal Tube Cuff Pressure; a Randomized Clinical Trial

NCT ID: NCT02294422

Last Updated: 2015-06-30

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

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Tracheal Damage

Keywords

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Loss of resistance Pilot balloon Cuff pressure Endotracheal tube

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

LOR

Intervention Type DEVICE

Aneroid manometer

Intervention Type DEVICE

The pilot balloon is attached onto the manometer and cuff pressures are raed off from the gauge.

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.

Group Type PLACEBO_COMPARATOR

PBP

Intervention Type DEVICE

the pilot balloon is continuously palpated o felt for adequate pressure as its being inflated.

Aneroid manometer

Intervention Type DEVICE

The pilot balloon is attached onto the manometer and cuff pressures are raed off from the gauge.

Interventions

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PBP

the pilot balloon is continuously palpated o felt for adequate pressure as its being inflated.

Intervention Type DEVICE

LOR

Intervention Type DEVICE

Aneroid manometer

The pilot balloon is attached onto the manometer and cuff pressures are raed off from the gauge.

Intervention Type DEVICE

Other Intervention Names

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Pilot balloon palpation technique LOR syinge VBM, Germany

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Makerere University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fred Bulamba, masters

Role: PRINCIPAL_INVESTIGATOR

Anaesthesiologist

Kintu Andrew, Fellowship

Role: STUDY_CHAIR

Lecturer

Arthur Kwizera, Masters

Role: STUDY_DIRECTOR

Lecturer

Locations

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Makerere University college of health sciences, Mulago National Referal Hospital Complex

Kampala, , Uganda

Site Status

Countries

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Uganda

Other Identifiers

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2012/HD07/1766U

Identifier Type: -

Identifier Source: org_study_id