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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02294422

Acronym

LOR-ETCP

Enrollment

178

Registered

2014-11-19

Start date

2014-04-30

Completion date

2015-02-28

Last updated

2015-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheal Damage

Keywords

Loss of resistance, Pilot balloon, Cuff pressure, Endotracheal tube

Brief summary

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.

Interventions

DEVICEPBP

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

DEVICELOR

DEVICEAneroid manometer

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The percentage of subjects with intracuff pressure ranging from 20cm H2O to 30cmH2O	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

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

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026