NCT03443947

Brief Summary

comparing a new technique for airway assessment using tongue depressor versus conventional mallampati scoring system. Using tongue depressor to improve airway score is suggested to increase reliability of airway assessment model

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

January 3, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

10 months

First QC Date

January 3, 2018

Last Update Submit

February 18, 2018

Conditions

Intubation;Difficult

Outcome Measures

Primary Outcomes (1)

  • assessment of airway difficulty

    correlation between airway score and view during laryngoscopy

    before intubation

Study Arms (1)

D group

EXPERIMENTAL
Device: Tongue depressor groupProcedure: control group

Interventions

Tongue depressor groupDEVICE

using a tongue depressor to assess airway score without tongue protrusion

D group
control groupPROCEDURE

airway assessment after tongue protrusion

D group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • all patients scheduled for elective surgery

You may not qualify if:

  • known difficult airway trismus cases maxillofacial anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mansoura university

Al Manşūrah, Dkahleya, Egypt

Location

Gastroenterology center

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

January 3, 2018

First Posted

February 23, 2018

Study Start

March 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

EG(2)