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

Makerere University

Status: Completed

Conditions: Tracheal Damage

Treatments: Device: LOR; Device: PBP; Device: Aneroid manometer

Study type: Interventional

Funder types: Other

Identifiers

NCT02294422

2012/HD07/1766U

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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178 participants in 2 patient groups, including a placebo group

2. LOR and aneroid manometer group

Experimental group

Description:

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.

Treatment:

Device: Aneroid manometer

Device: LOR

1. PBP and aneroid manometer group

Placebo Comparator group

Description:

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.

Treatment:

Device: Aneroid manometer

Device: PBP