Achieving Recommended Endotracheal Tube Cuff Pressure; A Randomized Control Trial Comparing Loss of Resistance Syringe to Pilot Balloon Palpation.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Makerere University
- Enrollment
- 178
- Locations
- 1
- Primary Endpoint
- The percentage of subjects with intracuff pressure ranging from 20cm H2O to 30cmH2O
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
2. LOR and aneroid manometer group
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.
Intervention: LOR (Device)
2. LOR and aneroid manometer group
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.
Intervention: Aneroid manometer (Device)
1. PBP and aneroid manometer group
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.
Intervention: PBP (Device)
1. PBP and aneroid manometer group
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.
Intervention: Aneroid manometer (Device)
Outcomes
Primary Outcomes
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
- Incidence of early postoperative airway symptoms(12 hours)