Comparison of Ultrasonographic and Anthropometric Measurements in Difficult Airway Evaluation

NCT ID: NCT04140981

Last Updated: 2019-12-20

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2019-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Difficult Airway Intubation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group 1

difficult intubation according to antropometric measurements

ultrasounography

Intervention Type DEVICE

in preoperative period, airway ultrasounagraphy for all patients will be made

group 2

not difficult intubation according to antropometric measurements

ultrasounography

Intervention Type DEVICE

in preoperative period, airway ultrasounagraphy for all patients will be made

group 3

difficult intubation according to ultrasound measurements

ultrasounography

Intervention Type DEVICE

in preoperative period, airway ultrasounagraphy for all patients will be made

group 4

not difficult intubation according to ultrasound measurements

ultrasounography

Intervention Type DEVICE

in preoperative period, airway ultrasounagraphy for all patients will be made

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ultrasounography

in preoperative period, airway ultrasounagraphy for all patients will be made

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kırıkkale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kevser Peker

assitant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kevser Peker

Role: PRINCIPAL_INVESTIGATOR

Kırıkkale University Faculty of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kırıkkale Univercity Faculty of Medicine Hospital

Kırıkkale, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

airway ultrasounography

Identifier Type: -

Identifier Source: org_study_id