NCT04264338

Brief Summary

Anesthesia is increasingly safe. Major complications of airway management are no more common but still the most life-threatening condition amongst anesthesia practice and even medicine. Thyromental height test (TMHT) is an objective measure of the height between the anterior borders of the mentum and thyroid cartilage, measured while the patient is lying supine with the mouth closed. This study was designed to assess the validity of the TMHT as a single objective predictor for difficult laryngoscopy and to be compared to other objective measures.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
612

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Status
unknown

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

February 3, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

February 20, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

6 months

First QC Date

February 3, 2020

Last Update Submit

February 10, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • validity of the TMHT in prediction of difficult airway in patients undergoing general anesthesia for elective surgeries using area under ROC curve for the TMHT.

    baseline (before induction of general anesthesia)

  • Validity of TMHT in comparison with that of Modified Mallampati test (MMT) in prediction of difficult airway by comparing area under ROC curve for both tests.

    baseline (before induction of general anesthesia)

Interventions

Assessment of difficult airway

Eligibility Criteria

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

Patients, aged from 18-60 years old, with ASA physical status I \& II who will undergo elective surgical procedures under general anesthesia using endotracheal intubation using conventional laryngoscopy.

You may qualify if:

  • ASA physical status I \& II
  • Scheduled for elective surgical procedures under general anesthesia using endotracheal with conventional laryngoscopy

You may not qualify if:

  • Patients with a body mass index \>35 kg/m2.
  • Patients with neuromuscular disorders, craniofacial abnormalities, and abnormal dentition.
  • Patients with airway diseases e.g cancer larynx or tongue, uncooperative patients, those who will need awake intubation and patients who will undergo emergency operations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

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

February 3, 2020

First Posted

February 11, 2020

Study Start

February 20, 2020

Primary Completion

August 20, 2020

Study Completion

October 20, 2020

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share