The Effect of Supraglottic Airway Insertion on the Accuracy of Cricothyroid Membrane Identification in Females

NCT03105037 | Completed

• 1 other identifier: REC-2017-001
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, observational, study that will examine if a sited supraglottic airway (the igel) will increase the accuracy of identifying the cricothyroid membrane in female patients. Consented patients that meet inclusion criteria are assessed by clinicians under general anaesthesia with and without a supraglottic airway in situ. The accuracy of CTM identification by palpation will be evaluated using ultrasound.

Conditions

Airway Obstruction

Outcome Measures

Primary Outcomes (1)

• accurate identification of the cricothyroid membrane

  accuracy of cricothyroid membrane identification, measured as either successful identification or unsuccessful (binary outcome). A successful identification is within 5mm of the midline and within the upper and lower borders of the cricothyroid membrane as measured using ultrasound.

  At clinician assessment, on the day of patient recruitment.

Secondary Outcomes (7)

• Accurate identification of the midline of the neck

  At clinician assessment, on the day of patient recruitment.

• Difficulty of cricothyroid membrane assessment

  At clinician assessment, on the day of patient recruitment.

• Time taken to attempt localisation of the cricothyroid membrane

  At clinician assessment, on the day of patient recruitment.

• Distance from clinician assessment to actual cricothyroid membrane location

  On blinded, retrospective ultrasound analysis of images captured at the time of clinician assessment of the cricothyroid membrane. Blinded retrospective ultrasound assessment is to take place within 3 months of patient recruitment

• The distance from the skin to the first tracheal ring

  On blinded, retrospective ultrasound analysis of images captured at the time of clinician assessment of the cricothyroid membrane. Blinded retrospective ultrasound assessment is to take place within 3 months of patient recruitment

Study Arms (1)

Study group

CTM assessed with supraglottic airway in situ and without

Eligibility Criteria

• Age: 18 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women attending for routine gynaecological surgery

You may qualify if:

• Women attending for routine surgery

You may not qualify if:

• unable to give informed consent
• abnormal neck anatomy
• history of gastroesophageal reflux
• history of neck surgery or radiotherapy
• contraindication to supraglottic airway device insertion

Sponsors & Collaborators

• The Rotunda Hospital: lead

Study Sites (1)

The Rotunda Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Conan McCaul

  Prof

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Study Investigor, SpR Anaesthetist

Study Record Dates

• First Submitted: March 25, 2017
• First Posted: April 7, 2017
• Study Start: January 31, 2017
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)