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

Not Applicable

Completed

• Conditions: Tracheal Damage
• Interventions: Device: LOR; Device: PBP; Device: Aneroid manometer

• Registration Number: NCT02294422
• Lead Sponsor: Makerere University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-08-02
• Study First Submitted QC: 2014-11-18
• Study First Posted: 2014-11-19
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-29
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2. LOR and aneroid manometer group	LOR	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.
1. PBP and aneroid manometer group	PBP	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.
2. LOR and aneroid manometer group	Aneroid manometer	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.
1. PBP and aneroid manometer group	Aneroid manometer	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Makerere University college of health sciences, Mulago National Referal Hospital Complex; 🇺🇬 Kampala, Uganda