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OpenTrials
Completed

NCT Number: NCT02294422

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

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.

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Key information

Conditions

Tracheal Damage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kampala, 256, Uganda

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PBP

Device

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

Other names: Pilot balloon palpation technique

LOR

Device

Other names: LOR syinge

Aneroid manometer

Device

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

Other names: VBM, Germany

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Registry information

Official study title

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

Acronym: LOR-ETCP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 19, 2014
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.