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NCT02294422 Clinical Trial

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

Tracheal Damage Clinical Trial

— LOR-ETCP  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02294422
Other study ID # 2012/HD07/1766U
Secondary ID
Status Completed
Phase N/A
First received August 2, 2014
Last updated June 29, 2015
Start date April 2014
Est. completion date February 2015

Study information
Verified date June 2015
Source Makerere University
Contact n/a
Is FDA regulated No
Health authority Uganda: National Council for Science and TechnologyUganda: National Drug Authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 178
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• PBP
the pilot balloon is continuously palpated o felt for adequate pressure as its being inflated.
• LOR

• Aneroid manometer
The pilot balloon is attached onto the manometer and cuff pressures are raed off from the gauge.

Locations
Country Name City State
Uganda Makerere University college of health sciences, Mulago National Referal Hospital Complex Kampala

Sponsors (1)
Lead Sponsor Collaborator
Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Incidence of early postoperative airway symptoms Patents will be reviewed 12 hours after extubation for cough, sore throat, dysphagia and dysphonia. 12 hours Yes

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