CTRI

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CTRI Number

CTRI/2025/03/082871 [Registered on: 20/03/2025] Trial Registered Prospectively

Last Modified On:

17/02/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Single Arm Study

Public Title of Study

What is the importance airway assessment in the prediction of difficult intubation in critically ill patients

Scientific Title of Study

Utility of airway assessment parameters to predict difficult intubation in critically ill patients A prospective observational study

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Saurabh Taneja
Designation	Senior consultant
Affiliation	Sir Ganga Ram Hospital
Address	Institute of critical care medicine 4th floor SSRB Building Sir Ganga Ram Hospital Rajinder Nagar, New Delhi, Delhi - 110060 New Delhi DELHI 110060 India
Phone	9811538315
Fax
Email	dr.saurabhtaneja@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Aman Kaur Saini
Designation	Drnb student
Affiliation	Sir Ganga Ram Hospital
Address	Institute of critical care medicine Sir Ganga Ram Hospital Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi, Delhi - 110060 New Delhi DELHI 110060 India
Phone	9810311816
Fax
Email	Nightfury992@gmail.com

Details of Contact Person
Public Query

Name	Dr Aman Kaur Saini
Designation	Drnb student
Affiliation	Sir Ganga Ram Hospital
Address	Institute of critical care medicine Sir Ganga Ram Hospital Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi, Delhi - 110060 New Delhi DELHI 110060 India
Phone	9810311816
Fax
Email	Nightfury992@gmail.com

Source of Monetary or Material Support

Institute of critical care medicine 4th floor ssrb building Sir Ganga Ram Hospital Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi, Delhi - 110060

Primary Sponsor

Name	Institute of critical care medicine Sir Ganga Ram Hospital
Address	Institute of critical care medicine 4th floor ssrb building Sir Ganga Ram Hospital Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi, Delhi - 110060
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Aman Kaur Saini	Institute of critical care medicine	4th floor SSRB building Sir Ganga Ram Hospital Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi, Delhi - 110060 New Delhi DELHI	9810311816 Nightfury992@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Sir Gangaram Hospital ethics committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: J969\|\|Respiratory failure, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	nil	nil
Comparator Agent	nil	nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	90.00 Year(s)
Gender	Both
Details	1. age more than 18 years 2. both male and female

ExclusionCriteria

Details

1. patients already intubated or tracheostimized
2. patients with cervical spine pathology
3. uncooperative patients
4. pregnant patients
5. patients with GCS Less than 8
6. refusal to participate.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To evaluate the importance of objective and subjective airway assessment parameters for prediction of difficult intubation	within 24 hours of ICU admission

Secondary Outcome

Outcome	TimePoints
To compare ability of above mentioned parameters for prediction of difficult intubation in critically ill patients.	At the baseline during icu admission

Target Sample Size

Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

14/03/2028

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Open to Recruitment

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

critically ill patients have a physiologically difficult airway due to associated underlying hypoxemia , hypotension , metabolic acidosis, and other physiological derangements, increasing the risk of complications during tracheal intubation. for successful airway management, a spectrum of knowledge and skills are required , one end of the spectrum is ability to predict difficulty with airway management and the other end is executing the airway management plan by using the wide array of airway devices. Several anatomical and functional maneuvers can be performed to estimate the difficulty of endotracheal intubation.