Status:
COMPLETED
Paediatric Microcuff Pressure Study
Lead Sponsor:
Nottingham University Hospitals NHS Trust
Conditions:
Anesthesia
Pediatric
Eligibility:
All Genders
Up to 16 years
Phase:
NA
Brief Summary
In paediatric anaesthesia, use of cuffed endotracheal (ET) tubes is subject to much debate. The concern is the possibility of damage to tracheal mucosa by excessive pressure from the cuff. The cuff pr...
Detailed Description
During surgery under anaesthesia, use of cuffed endotracheal (ET) tubes is standard practice in adults. The cuff prevents air leak and protects the airway from soiling. Traditionally, in paediatric pr...
Eligibility Criteria
Inclusion
- Parent/guardian's written informed consent / age-appropriate participant assent
- Age: Birth to 16 years
- Elective surgery
- Endotracheal intubation with a cuffed tube required as part of general anaesthesia lasting longer than 45 minutes
- Planned use of N2O as part of balanced anaesthesia
- For questionnaire follow up; aged over 8 years without significant neurological impairment
Exclusion
- Weight less than 3kg
- Laryngeal or tracheal pathology, including respiratory tract infections
- Difficulty in intubation (\>2 attempts)
- NG tube placement during anaesthesia
- Nose, throat or airway surgery
Key Trial Info
Start Date :
August 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2019
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03240354
Start Date
August 6 2018
End Date
July 30 2019
Last Update
February 20 2020
Active Locations (1)
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1
Nottingham University Hospital
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH