Paediatric Microcuff Pressure Study (MicroCuff)

February 18, 2020 updated by: Nottingham University Hospitals NHS Trust

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 practice an uncuffed ET tube is used, sized according to the child's age. This prevents damage to the lining of the trachea by excessive pressure from the cuff.

The debate regarding the use of cuffed ET tubes in children is long-standing. New insight into the understanding of paediatric airway anatomy and newer designs of cuffed ET tubes (such as the MicroCuff Endotracheal tube, Halyard Health UK) have resulted in a shift towards their more frequent use. Studies suggest cuff pressures should be maintained below 20 - 25cm H2O, to minimise airway complications related to high pressures on the tracheal lining leading to inadequate blood flow, potentially causing swelling and, rarely, tracheal stenosis. This is of particular importance in small children, where even slight swelling can significantly reduce the airway diameter, with potentially serious consequences. 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.

The widespread use of nitrous oxide (N2O) in paediatric anaesthesia raises another issue. Nitrous oxide diffuses easily into the ET tube cuffs, raising the pressure within them. Various interventions have been trialled in adult studies to address this. Inflating ET tube cuffs with a mixture of air and N2O may be beneficial, but varying concentrations of N2O during anaesthesia limit the benefits. Filling the cuff with saline instead of air has been shown to prevent increases in cuff pressures in the adult population without any adverse safety issues, but it is still not standard practice.

Despite reports of similar variation in cuff pressures in paediatric patients, there have been no reported studies to date comparing the intra-operative changes in cuff pressures in children when the cuff is inflated with saline instead of air.

Therefore, the investigators propose to determine whether filling the ET tube cuff with saline prevents the changes in intra-cuff pressures, in children undergoing balanced anaesthesia with N2O, that are seen with air filled cuffs.

CLINICAL RELEVANCE The use of cuffed tubes in paediatric anaesthesia has become more and more common over the last decade. Newer, more anatomically based designs have helped to overcome many of the potential problems, but the issue of safe cuff pressures remains paramount.

Work in the adult literature has demonstrated the pressure at which there is a reduction in capillary perfusion. In paediatrics, the huge variation in capillary perfusion pressure makes finding an exact 'safe' level for every patient very difficult, but attempts have been made to characterise what an 'unsafe' level is.

The widespread use of nitrous oxide in paediatric anaesthesia also complicates the situation. The cuffs on modern paediatric cuffed tubes are very thin, allowing gasses to diffuse into them more easily. This means the volume (and thus the pressure) at the beginning of anaesthesia is not the same as at the end. Studies have also shown that the incidence of post-operative airway complications increases as the cuff pressure increases.

The AABGI has recently recommended cuff pressure monitoring as a minimum standard of care. However, achieving this through a lengthy case, where access to the airway may be limited, can prove challenging.

This studies hypothesis is that the use of saline, instead of air, in the cuff will lead to reduced pressure variation during anaesthesia, meaning that the pressure in the cuff at the end would be the same as at the beginning. This would minimise risk of complications for the patient and give a high level of patient safety and satisfaction, with minimal extra workload for the anaesthetist or expense for the NHS.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Nottingham University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Saline
Use of saline to inflate cuff of endotracheal tube
Device: Saline cuff
Cuff of endotracheal tube inflated with saline rather than air (control)
Active Comparator: Control
Use of air to inflate cuff of endotracheal tube
Device: Control
Cuff of endotracheal tube inflated with air

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of cases where an intervention was required to maintain cuff pressure below 25cm H2O
Time Frame: Intra-operative, 45min - 6 hours
  • During anaesthesia, the pressure in the ET tube cuff will be measured continuously by an investigator, separate from the team providing the anaesthesia, using an arterial line pressure transducer set attached to the pilot balloon through a 3-way tap. The initial cuff pressure will be recorded ('Pressure 0')
  • The cuff pressure will be documented every 5 minutes.
  • If the cuff pressure exceeds 25 cm H2O for more than 30 seconds (to exclude artefactual changes), the volume of fluid in the cuff will be reduced until the pressure is returned to the initial level ('Pressure 0').
  • This constitutes an 'Intervention'
Intra-operative, 45min - 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cuff pressure in each group
Time Frame: Intra-operative, 45min - 6 hours
The mean cuff pressure for each patient will be calculated based on the recordings taken during the case
Intra-operative, 45min - 6 hours
Post extubation adverse events
Time Frame: up to 20min Post extubation
After removal of the ET tube at the end of the case, the attending anaesthetist will note any episodes of cough, stridor, laryngospasm, bradycardia of more than 10% from baseline or desaturation to below 92%, or by more than 10% from baseline. These will constitute a 'post extubation adverse event'
up to 20min Post extubation
Post-operative airway complications
Time Frame: up to 24 hours post-op

Post-operatively, prior to recovery discharge, children 8 years of age and over will be asked, by an observer blinded to their study group, to score any sore throat, dysphagia or hoarseness on a numerical rating scale.

These questions will be asked again 8 - 24 hours post-operatively, prior to discharge home.
up to 24 hours post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham University Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2018

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

July 17, 2017

First Submitted That Met QC Criteria

August 4, 2017

First Posted (Actual)

August 7, 2017

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 17AN003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data will not be shared outside the immediate research team

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anesthesia

Clinical Trials on Saline cuff

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe