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

NCT ID: NCT03105037

Last Updated: 2018-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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Palpation of the airway structures results in misidentification of the cricothyroid membrane (CTM) in a high proportion of women. Female front of neck anatomy is less distinct compared to males with reduced angulation of the laryngeal cartilages making it harder to distinguish the relevant landmarks. In obese patients, overlying subcutaneous tissue compounds this problem and several studies have demonstrated poor success identifying the CTM by palpation in this population. Supraglottic airway device (SAD) insertion precedes emergency front of neck access attempts in the stepwise progression from failed intubation to cricothyroidotomy. The nature and clinical implication of SAD insertion on cricothyroidotomy remain unstudied.

Sixty four patients will undergo front of neck airway assessment by volunteer clinicians with and without a SAD in situ (control and SAD assessments, within-subjects design). The patients are fasting women presenting for routine gynaecological surgery. Eight anaesthetists, at different levels of training, will perform eight individual CTM assessments with and without the SAD in situ.

Ultrasound images will be captured in the sagittal plane immediately before and after supraglottic airway insertion. Images are then downloaded, anonymised and randomised for blinded digital analysis.

Conditions

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Airway Obstruction

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

CTM assessed with supraglottic airway in situ and without

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Women attending for routine surgery

Exclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Rotunda Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tom Drew

Principal Study Investigor, SpR Anaesthetist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Conan McCaul

Role: STUDY_DIRECTOR

Prof

Locations

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The Rotunda Hospital

Dublin, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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REC-2017-001

Identifier Type: -

Identifier Source: org_study_id

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