NCT06925165

Brief Summary

Evaluation the role of ultrasound measured hyomental distance to tongue thickness ratio in predicting difficult intubation in infants

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

January 29, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2025

Completed
Last Updated

April 13, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 6, 2025

Last Update Submit

April 6, 2025

Conditions

Ultrasound

Outcome Measures

Primary Outcomes (1)

  • role of ultrasound measured hyomental distance to tongue thickness ratio in predicting difficult intubation in infants.

    Difficult intubation can be a significant life threatening problem in anesthesia which can lead to serious complications like hypoxia, aspiration, esophageal intubation, emergency surgical airway, cardiovascular instability, cardiac arrhythmias, ischemic encephalopathy, and death. In the study investigators will use hyomental distance and tongue thickness measured by ultrasound to suspect difficult intubation in infants aged 1 to 12 month.

    2 to 3 minutes after induction of anaesthesia and intubation

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants aged 1 to 12 months

You may qualify if:

  • Infants aged 1 to 12 months
  • Both sexes.
  • Physical status ASA I or II

You may not qualify if:

  • Restricted mobility of temporomandibular joint
  • Absent anesthesia or surgical consent
  • Maxillofacial trauma or tumors
  • A large mass or scar under the chin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt, 11111, Egypt

Location

Study Officials

  • Shaimaa Reda Ahmed, MBBCH

    Anesthesia resident Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2025

First Posted

April 13, 2025

Study Start

January 29, 2025

Primary Completion

July 29, 2025

Study Completion

July 29, 2025

Last Updated

April 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

all data will be shared once study is completed

Time Frame
before 1/2026
Access Criteria
free

Locations

EG(1)