CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 49 enrolled
Drug / intervention
Saline cuff +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03240354
NCT03240354N/ACompleted

Reducing Intra-operative Pressure Variations in Paediatric Microcuff Endotracheal Tube Cuffs

Nottingham University Hospitals NHS Trust·interventional·Posted Aug 7, 2017·Updated Feb 20, 2020

In Brief

A clinical study evaluating Saline cuff and Control for Anesthesia and 2 related conditions. Completed, enrolled 49 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 7, 2017
Enrollment StartAug 6, 2018
Primary CompletionJul 30, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.9 years ago

Interventions

Saline cuffdevice

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

Controldevice

Cuff of endotracheal tube inflated with air