NCT01637207

Brief Summary

The Investigators aim to determine how easy it is for anaesthetists to identify the Cricothyroid membrane (CTM) in children and infants and whether ultrasound maybe useful in addition. The investigators aim to conduct a randomised single blinded trial to compare methods to detect the CTM. The first group of patients will be randomised to palpation of anatomical landmarks group. Prior to commencing the MRI scan the anaesthetist is timed to identify the CTM and then the trachea using a felt tip pen. A ficidual marker will be placed on the 2 marked areas. The second group of patients will be randomised to receive ultrasound. Prior to commencing the MRI scan the sonographer is timed to identify the CTM and then the trachea using a felt tip pen. A ficidual marker will be placed on the two marked areas.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

1.3 years

First QC Date

June 1, 2012

Last Update Submit

October 3, 2022

Conditions

Cricothyroidotomy

Outcome Measures

Primary Outcomes (1)

  • Accuracy of placement of the marker

    Accuracy of the placement of the marker in relation to the cricithyroid membrane and trachea on MRI images.

    4-6 months

Secondary Outcomes (1)

  • Time taken to identify CTM/Trachea

    4-6 months

Study Arms (2)

palpation

EXPERIMENTAL
Other: Palpation

ultrasound

EXPERIMENTAL
Other: Ultrasound

Interventions

PalpationOTHER

Group A: Palpation Group

palpation
UltrasoundOTHER

Group B: Ultrasound Group

ultrasound

Eligibility Criteria

AgeUp to 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All children between 0-8 years requiring general anaethesia for elective MRI head, neck and spinal scans

You may not qualify if:

  • Children with obvious neck deformity, goitre, tracheostomy and emergency cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Great Ormond Street Hospital for Sick Children NHS Foundation Trust

London, WC1N 3JH, United Kingdom

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Nadine Dobby, MBBS

    Great Ormond Street Hospital for Sick Children NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2012

First Posted

July 11, 2012

Study Start

August 1, 2011

Primary Completion

November 1, 2012

Study Completion

February 1, 2013

Last Updated

October 4, 2022

Record last verified: 2022-10

Locations

GB(1)