Clinical Trials Directory

Trials / Completed

CompletedNCT03105037

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

The Effect of Supraglottic Airway Insertion on the Accuracy of Cricothyroid Membrane Identification in Females- a Prospective Observational Study.

Status
Completed
Phase
Study type
Observational
Enrollment
64 (actual)
Sponsor
The Rotunda Hospital · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers

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.

Detailed description

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

Timeline

Start date
2017-01-31
Primary completion
2017-03-31
Completion
2017-03-31
First posted
2017-04-07
Last updated
2018-09-25

Locations

1 site across 1 country: Ireland

Source: ClinicalTrials.gov record NCT03105037. Inclusion in this directory is not an endorsement.