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

Not Applicable
Completed
Conditions
Tracheal Damage
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

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
Primary Outcome Measures
NameTimeMethod
The percentage of subjects with intracuff pressure ranging from 20cm H2O to 30cmH2O5minutes

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
NameTimeMethod
Incidence of early postoperative airway symptoms12 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

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

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