NCT03799055

Brief Summary

The aim of this study to assess and compare between methods of prediction of difficult airway including Mallmpati score , thyromental distance and us measured distance from skin to epiglottis(DES) t the level of thyrohyoid membrane in adult patients requiring endotracheal intubation for an elective surgical procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

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

January 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

June 10, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

7 months

First QC Date

January 8, 2019

Last Update Submit

April 20, 2020

Conditions

Difficult Intubation

Outcome Measures

Primary Outcomes (1)

  • Prediction of difficult airway

    Assess which method is better for prediction of difficult airway DES or conventional

    Preoperative

Study Arms (2)

easy intubation

Cormack \_Lehane : 1\&2

difficult intubation

Cormack \_Lehane : 3\&4

Eligibility Criteria

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

Patients at Benha University Surgical Hospital scheduled for elective surgical procedures requiring endotracheal tube

You may qualify if:

  • American Society of Anaesthesia class 1,2and 3.
  • elective surgical procedure requiring endotracheal intubation.
  • Age 18\_60 years old.
  • BMI less than 40kg/meter square.

You may not qualify if:

  • patients refusal.
  • Unable to give consent.
  • Preexisting airway malformations or pathology.
  • History of difficult intubation.
  • Pregnancy.
  • Patients with tracheostomy tube.
  • BMI more than 40 kg/meter square.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University Hospital

Banhā, Banha, 13518, Egypt

Location

Study Officials

  • Faculty Of Medicine

    faculty of medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 8, 2019

First Posted

January 10, 2019

Study Start

June 10, 2019

Primary Completion

December 29, 2019

Study Completion

January 10, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)