NCT04212156

Brief Summary

Difficult airway management is a major concern for anesthetists and contributes to perioperative morbidity and mortality. The incidence of difficult intubation in the obese population with a BMI of greater than 30 has been reported to be 15.8%. Thyromental height test (TMHT) is a new bedside test for difficult airway, it is a measure of the height between the anterior borders of the mentum and thyroid cartilage. TMHT can act as a surrogate for amount of mandibular protrusion; dimensions of submandibular space; and anterior position of the larynx. It appears promising as a single anatomical measure to predict the risk of difficult laryngoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

Same day

First QC Date

December 23, 2019

Last Update Submit

May 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • TMHT

    Validity of TMHT for prediction of difficult airway in obese patient undergoing general anesthesia

    before induction of general anesthesia

Study Arms (1)

TMH test

Patient will be asked to lay supine while the head and neck maintained in a neutral position using a pillow under the head. By using digital depth gauge, the TMH will be measured from the anterior border of the thyroid cartilage directly on the thyroid notch till the anterior border of the mentum

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients of both sex, aged between 18-60 years old, ASA physical status II\& III with BMI \> 30 Kg/m2 who will undergo elective surgical procedures under general anesthesia using endotracheal intubation using conventional laryngoscopy

You may qualify if:

  • Patients aged between 18-60 years old, ASA physical status II\& III with BMI \> 30 Kg/m2 who will undergo elective surgical procedures under general anesthesia using endotracheal intubation with conventional laryngoscopy

You may not qualify if:

  • Patients with neuromuscular disorders, craniofacial abnormalities, abnormal dentition, uncooperative, who need awake intubation and patients who undergoing emergency operations will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abeer Ahmed

Maadi, Cairo Governorate, 11562, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia, SICU & pain management. Kasralainy Faculty of medicine

Study Record Dates

First Submitted

December 23, 2019

First Posted

December 26, 2019

Study Start

January 20, 2020

Primary Completion

January 20, 2020

Study Completion

January 20, 2021

Last Updated

May 17, 2021

Record last verified: 2021-05

Locations