Comparison of Ultrasonographic and Anthropometric Measurements in Difficult Airway Evaluation

Evaluation of Ultrasounographic Measurements and Anthropometric Measurements as Predictors of Difficult Direct Laryngoscopy

In this study, anthropometric measurements (clinical measurements) will be applied in all patient groups; expected (to be difficult to provide airway patency as a result of detailed history, physical examination and evaluation tests performed by an experienced anesthesiologist), and unexpected (although it was not predicted that a difficulty was encountered). And ultrasounographic measurements will be applied in all patients. The aim of this study is to evaluate the predictive accuracy of ultrasonographic measurements.

Study Overview

• Status: Completed
• Conditions: Difficult Airway Intubation
• Intervention / Treatment: Device: ultrasounography

Detailed Description

In the preoperative period, the following clinical tests will be performed before the patient arrives in the operating room and when the patient arrives, the measurements will be made by ultrasonography.

1. Mallampati classification
2. Determination of mouth opening (interinsizer distance)
3. Thyromental distance
4. Sternomental distance

Preoperative evaluation of the patients and clinical results of the airway tests (mentioned above) will be recorded. The cervical soft tissue thickness will be measured and recorded at 3 levels (thyrohyoid membrane, vocal cord, hyoid bone) with the help of ultrasonography (mentioned above). In addition, since all patients will be under general anesthesia, laryngoscopic images (laryngoscopic evaluation according to Cormack Lehane classification) routinely recorded on the anesthesia follow-up sheet will be recorded.

• Study Type: Observational
• Enrollment (Actual): 127

Contacts and Locations

Study Locations

• Turkey
  • Kırıkkale, Turkey, 71450
    • Kırıkkale Univercity Faculty of Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

ASA 1-2-3, 18-75 aged, patients undergoing general anesthesia

Description

Inclusion Criteria:

• patients under general anesthesia
• ASA 1-2-3

Exclusion Criteria:

• Patients who will undergo emergency surgery,
• pregnant women,
• children,
• patients who may have difficulty in airway management due to cervical instability,
• patients with trauma or malignancy in the neck region

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group 1; difficult intubation according to antropometric measurements	Device: ultrasounography; in preoperative period, airway ultrasounagraphy for all patients will be made
group 2; not difficult intubation according to antropometric measurements	Device: ultrasounography; in preoperative period, airway ultrasounagraphy for all patients will be made
group 3; difficult intubation according to ultrasound measurements	Device: ultrasounography; in preoperative period, airway ultrasounagraphy for all patients will be made
group 4; not difficult intubation according to ultrasound measurements	Device: ultrasounography; in preoperative period, airway ultrasounagraphy for all patients will be made

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cormack Lehane classification	Laryngoscopic evaluation according to Cormack Lehane classification	during the intubation period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ultrasonographic measurement	Preoperative ultrasonographic measurement will be made	15 min before the operation

Collaborators and Investigators

• Sponsor: Kırıkkale University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 19, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: airway ultrasounography

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No