Thyromental Height Test as a Predictor of Difficult Airway: | NCT04264338

Studies
Thyromental Height Test as a Predictor of Difficult Airway:

NCT04264338

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Feb 11, 2020Actual

Enrollment

612Estimated

Phase

Not provided

Conditions

Difficult Intubation

Interventions

Thyromental height test

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2020Estimated

Primary Completion Date

Aug 20, 2020Estimated

Completion Date

Oct 20, 2020Estimated

First Submitted Date

Feb 3, 2020

First Submission Date that Met QC Criteria

Feb 10, 2020

First Posted Date

Feb 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2020

Last Update Posted Date

Feb 11, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abeer Ahmed, MD, Assistant Professor of Anesthesia, SICU & pain management. Kasralainy Faculty of medicine, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

612Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thyromental height test	Diagnostic Test	Assessment of difficult airway

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abeer Ahmed, MD	Contact	01005244590		abeer_ahmed@kasralainy.edu.eg

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided