NCT06057818

Brief Summary

The purpose of this study is to evaluate the ability of pre-operative ultrasound assessment of neck anatomy in predicting difficult laryngoscopy in obese patients undergoing elective surgery requiring tracheal intubation and comparing it to conventional methods as the Mallampati score in anticipating difficult laryngoscopy.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

September 20, 2023

Last Update Submit

February 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison between the Mallampati score and the airway ultrasound

    Comparison between the Mallampati score and the airway ultrasound measurements in the prediction of difficult intubation in obese patients

    6 months

Secondary Outcomes (1)

  • comparison between each airway ultrasound measurement

    6 months

Eligibility Criteria

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

patients of both sexes (18-60 years old) with an American Society of Anesthesiologists physical status classification score of I to III, scheduled for elective surgical procedure requiring endotracheal intubation and body mass index more than 30 kg/m2.

You may qualify if:

  • Both sexes
  • Age from18 to 60 years old
  • With an American Society of Anesthesiologists physical status classification score of I to III,
  • Scheduled for elective surgical procedure requiring endotracheal intubation
  • Body mass index more than 30 kg/m2.

You may not qualify if:

  • Patient refusal
  • Emergency surgery
  • Patients with history of airway or neck surgery
  • Neck mobility abnormalities
  • Syndromatic patients
  • Pre-existing airway malformations or pathology like facial or cervical fractures, maxillofacial abnormalities, cervical tumors or goiter.
  • History of difficult intubation.
  • Patients with tracheostomy tubes.
  • Pregnant patients.
  • Body mass index less than 30 kg/m2.
  • ASA IV or above patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

September 20, 2023

First Posted

September 28, 2023

Study Start

March 1, 2024

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

February 13, 2024

Record last verified: 2024-02

Locations