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Paediatric Microcuff Pressure Study (MicroCuff)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03240354
Recruitment Status : Not yet recruiting
First Posted : August 7, 2017
Last Update Posted : March 15, 2018
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust

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 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.

Condition or disease Intervention/treatment Phase
Anesthesia Pediatric Intubation Complication Device: Saline cuff Device: Control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, blinded, randomised, parallel group control trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
  • Participants will be split into two age groups, 'under 8 years' and '8 years and over', and a stratified randomisation method will be used to randomise each group, using a previously verified, sealed envelope, method and using blocks of unequal size.
  • Envelopes will be prepared using a random number table by an individual with no further role in the study
  • Each participant will be given a unique randomisation code matching the randomisation list
  • A record of each randomisation will be recorded on the Enrolment Log (TAFR01502)
Primary Purpose: Treatment
Official Title: Reducing Intra-operative Pressure Variations in Paediatric Microcuff Endotracheal Tube Cuffs
Estimated Study Start Date : July 30, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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'

Secondary Outcome Measures :
  1. 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

  2. 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'

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03240354

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Contact: James Armstrong, MBBS 00441159249924 ext 61195

Sponsors and Collaborators
Nottingham University Hospitals NHS Trust


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Responsible Party: Nottingham University Hospitals NHS Trust Identifier: NCT03240354     History of Changes
Other Study ID Numbers: 17AN003
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared outside the immediate research team

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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