How Easy is it to Identify the Cricothyroid Membrane in Children? Can Ultrasound Imagine be Used to Aid Identification?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Great Ormond Street Hospital for Children NHS Foundation Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01637207
First received: June 1, 2012
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Cricothyroidotomy
Other: Palpation
Other: Ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: How Easy is it to Identify the Cricothyroid Membrane in Children? Can Ultrasound Imaging me Used to Aid Identification?

Resource links provided by NLM:


Further study details as provided by Great Ormond Street Hospital for Children NHS Foundation Trust:

Primary Outcome Measures:
  • Accuracy of placement of the marker [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
    Accuracy of the placement of the marker in relation to the cricithyroid membrane and trachea on MRI images.


Secondary Outcome Measures:
  • Time taken to identify CTM/Trachea [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
    Time taken to identify CTM/Trachea placement confidence assessed using the VAS Score (0-100: impossible to very confident). Comparison between age groups 0-4 years Vs 4-8 years.


Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: palpation Other: Palpation
Group A: Palpation Group
Experimental: ultrasound Other: Ultrasound
Group B: Ultrasound Group

Detailed Description:

Cricothyroidotomy is an infrequent but potentially life-saving procedure. The need for cricothyroidotomy arises from the can't intubate and can't ventilate (CICV) scenario and is therefore incorporated in the difficult airway guidelines for both adults and children. This CICV scenario is less common in the paediatric population than in the adult population and most difficult airways can be managed with-bag mask ventilation and PEEP.

The cricothyroid membrane is a useful place to access the airway in the case of glottic or supraglottic obstruction as it is relatively avascular, superficial and the 'full ring' of the cricoid protects against posterior perforation. In adults, the average the cricothyroid membrane CTM is 13.7mm long and 12.4mm wide. The CTM is relatively short in children. In neonates the CTM has a mean height of 2.6mm and a width of 3mm.

In children the most prominent anterior midline structures in the neck are not the thyroid as in adults but the hyoid bone and cricoid cartilage. As the larynx is more cephalad in children the cricothyroid membrane is higher than in adults and placement of a catheter may be more difficult as the mandible gets in the way. A healthy amount of adipose in the subcutaneous tissue can obscure the anatomy. Currently clinicians identify the CTM using palpation of anatomical landmarks. In infants, with the head in extension and soft tissue pulled up towards the mandible, the CTM may be difficult to distinguish. It is suggested that bimanual manipulation may enable identification of the cartilaginous trachea.

To perform a cricothyroid puncture, a syringe containing sterile saline is attached to a cannula. The skin over the cricothyroid membrane is stabilised with the index finger and thumb of the non-dominant hand. The transtracheal cannula is inserted through the cricothyroid membrane at a 45º angle heading caudal and posterior. However, in neonates due to the restricted dimensions, a needle is the only option for cricothyroidotomy. Even in experienced hands, cricothyroidotomy is technically challenging. In inexperienced hands this can lead to significant injuries including the risk of fracture of the thyroid and cricoid cartilages.

A recent abstract has tried to determine whether how easy it is to locate the CTM in children. Their initial conclusions suggest that the identification of the CTM is difficult. The limitations of their study are that there are small numbers and only one person has been asked to perform the identification.

The applications of ultrasound are vast and varied. It is readily available, portable and easy to use. Of note, a recent study has used ultrasound (Sonosite 10Hz) to help identify the CTM in adults. Following a period of training, it was found to improve accuracy and speed of identification.

The investigators aim to determine how easy it is for anaesthetists to identify the CTM in children and infants and whether ultrasound maybe a useful adjunct. The investigators aim to conduct a randomized single blinded trial to compare methods to detect the CTM: palpation of anatomical landmarks versus ultrasound .

  Eligibility

Ages Eligible for Study:   up to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Children with obvious neck deformity, goitre, tracheostomy and emergency cases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637207

Contacts
Contact: Nadine Dobby, MBBS nadine.dobby@gosh.nhs.uk

Locations
United Kingdom
Great Ormond Street Hospital for Sick Children NHS Foundation Trust Not yet recruiting
London, United Kingdom, WC1N 3JH
Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
Investigators
Principal Investigator: Nadine Dobby, MBBS Great Ormond Street Hospital for Sick Children NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01637207     History of Changes
Other Study ID Numbers: 10AR11
Study First Received: June 1, 2012
Last Updated: July 10, 2012
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on September 14, 2014