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Paediatric Microcuff Pressure Study

NCT03240354 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2020-02-20

No results posted yet for this study

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 pressure can increase during anaesthesia, especially if nitrous oxide is used.

Using saline to inflate the cuff has been shown to reduce intra-operative cuff pressure variation in adult studies, although it is not standard practice. Although the literature contains reports of cuff pressure increases during paediatric anaesthesia, there are no reports of attempts to address this. Use of pressure monitoring is recommended by AAGBI, but may not be consistently done. A safe method of limiting pressure, that is effective, imposes minimal extra workload and has minimal cost, would reduce risk to patients.

This study aims to investigate the effect on intra-operative cuff pressure of using saline to inflate the ET tube cuff, compared to standard practice of air inflation. Continuous pressure monitoring will be used to determine the proportion of cases where interventions are required to keep the pressure below a safe maximum level.

Conditions

  • Anesthesia
  • Pediatric
  • Intubation Complication

Interventions

DEVICE

Saline cuff

Cuff of endotracheal tube inflated with saline rather than air (control)

DEVICE

Control

Cuff of endotracheal tube inflated with air

Sponsors & Collaborators

  • Nottingham University Hospitals NHS Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-06
Primary Completion
2019-07-30
Completion
2019-07-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03240354 on ClinicalTrials.gov