NCT05735106

Brief Summary

To assess accuracy of NC/TM distance ratio in terms of sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) for predicting difficult intubation in obese patient with Intubation difficulty score (IDS) as gold standard.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

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

Study Start

First participant enrolled

October 21, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

February 9, 2023

Last Update Submit

October 8, 2024

Conditions

Difficult / Failed Intubation

Keywords

difficult intubationNC/TM distance ratiointubation difficulty score

Outcome Measures

Primary Outcomes (1)

  • Predictability of difficult airway

    At the preanaesthetic examination neck circumference to thyromental distance ratio will be caculated in obese patients with BMI ≥ 30KG/m2 and the predictability of difficult airway will be evaluated by statistical analysis

    During anaesthesia induction

Study Arms (2)

Group A (predicted easy intubation)

Group A labelled as predicted easy intubation on the basis of NC/TM distance ratio \<5

Group B (predicted difficult intubation)

Group B labelled as predicted Difficult intubation on the basis of NC/TM distance ratio ≥ 5

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obese patients (BMI ≥30Kg/m2) of all genders, between age of 18 to 65 years, belonging to ASA class I-III, Undergoing elective surgery under general anesthesia

You may qualify if:

  • ASA physical status I to III
  • Body Mass Index (BMI) of 30kg/m2 or more
  • age 18-65 years

You may not qualify if:

  • non consenting
  • ASA class greater than III,
  • patients undergoing general anesthesia without tracheal intubation or under regional anesthesia,
  • patients with upper airway pathology such as maxillofacial fractures, upper airway tumors or cervical spine fracture, obstetric patients, refusal of the patient, previous head and neck surgery or radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KRL Hospital

Islamabad, ICT, 44090, Pakistan

Location

Study Officials

  • Mahnoor Shabbir

    KrlH Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 21, 2023

Study Start

October 21, 2021

Primary Completion

April 21, 2022

Study Completion

May 21, 2022

Last Updated

October 10, 2024

Record last verified: 2024-10

Locations

PA(1)