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

Study Overview
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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.

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

Conditions
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Tracheal Damage

Intervention / Treatment
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* Device: PBP
* Device: LOR
* Device: Aneroid manometer


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2. LOR and aneroid manometer group<br>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. | Device: LOR<br> <br> * Other names: LOR syinge;Device: Aneroid manometer<br>* The pilot balloon is attached onto the manometer and cuff pressures are raed off from the gauge.<br>* Other names: VBM, Germany;|
| Placebo Comparator: 1. PBP and aneroid manometer group<br>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. | Device: PBP<br>* the pilot balloon is continuously palpated o felt for adequate pressure as its being inflated.<br>* Other names: Pilot balloon palpation technique;Device: Aneroid manometer<br>* The pilot balloon is attached onto the manometer and cuff pressures are raed off from the gauge.<br>* Other names: VBM, Germany;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of subjects with intracuff pressure ranging from 20cm H2O to 30cmH2O | 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 | 5minutes | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Loss of resistance, Pilot balloon, Cuff pressure, Endotracheal tube