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

September 23, 2018 updated by: Tom Drew, The Rotunda Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • The Rotunda Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women attending for routine gynaecological surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Study group
CTM assessed with supraglottic airway in situ and without

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
accurate identification of the cricothyroid membrane
Time Frame: At clinician assessment, on the day of patient recruitment.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Accurate identification of the midline of the neck
Time Frame: At clinician assessment, on the day of patient recruitment.
Accurate identification of the midline of the neck, binary outcome. A successful identification is within 5mm of the midline of the cricothyroid membrane as measured using ultrasound.
At clinician assessment, on the day of patient recruitment.
Difficulty of cricothyroid membrane assessment
Time Frame: At clinician assessment, on the day of patient recruitment.
Difficulty of assessing the cricothyroid membrane as graded subjectively by the clinician using a visual analogue scale (VAS) where '0' is the easiest possible assessment of the location of the cricothyroid membrane and '10' is the most difficult possible assessment of the location of the cricothyroid membrane.
At clinician assessment, on the day of patient recruitment.
Time taken to attempt localisation of the cricothyroid membrane
Time Frame: At clinician assessment, on the day of patient recruitment.
The time taken in seconds 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
Time Frame: 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 measured from the clinicians estimate of where the cricothyroid membrane is to where the actual location of the CTM is using ultrasound and measured in millimetres
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
Time Frame: 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 superficial surface of the first tracheal ring measured in millimetres using digital analysis of ultrasound images
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 cricoid cartilage
Time Frame: 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 superficial surface of the first tracheal ring measured in millimetres using digital analysis of ultrasound images
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 angle between the surface tissue interface of the cricothyroid membrane and the trachea
Time Frame: 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 angle between the surface tissue interface of the cricothyroid membrane and the trachea measured in degrees using digital analysis of ultrasound images
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Rotunda Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Conan McCaul, Prof

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC-2017-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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