| CTRI Number |
CTRI/2024/03/063639 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An study to compare different neck parameter measurements for assessment of difficult tracheal intubation. |
|
Scientific Title of Study
|
“comparasion of different neck parameters as the predictive test for difficult tracheal intubation:An observational study.â€
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjeev Kumar |
| Designation |
Junior Resident |
| Affiliation |
Teerthanker mahaveer medical college and research center , moradabad, uttar pradesh |
| Address |
Department of anesthesia, teerthanker mahaveer medical college and research center moradabad, uttar pradesh
Department of anesthesia, teerthanker mahaveer medical college and research center moradabad, uttar pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7599173002 |
| Fax |
|
| Email |
saini6397313529@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Shahbaz alam |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and research center, Moradabad, Uttar pradesh |
| Address |
Department of Anesthesia, Teerthanker Mahaveer Medical College and Research Center Moradabad, Uttar Pradesh
Department of Anesthesia, Teerthanker Mahaveer Medical College and Research Center Moradabad, Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9897907372 |
| Fax |
|
| Email |
dralamshahbaz006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjeev Kumar |
| Designation |
Junior Resident |
| Affiliation |
Teerthanker Mahaveer Medical College and research center, Moradabad, Uttar pradesh |
| Address |
Department of Anesthesia Teerthanker Mahaveer Medical College and Research Center Moradabad, Uttar Pradesh
Department of Anesthesia Teerthanker Mahaveer Medical College and Research Center Moradabad, Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7599173002 |
| Fax |
|
| Email |
saini6397313529@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College , Moradabad, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical College and Research Center Moradabad Uttar Pradesh |
| Address |
Teerthanker Mahaveer Medical College and Research Center Moradabad, Uttar Pradesh |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sanjeev Kumar |
Teerthanker Mahaveer Medical college, Moradabad, Uttar pradesh |
Room No 204, 2nd Floor,Department of Anesthesia Teerthanker Mahaveer Medical College and Reasearch Center Moradabad, Uttar Pradesh
Moradabad
UTTAR PRADESH |
7599173002
saini6397313529@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE , T, M UNIVERSITY, MORADABAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z018||Encounter for other specified special examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 & 2 |
|
| ExclusionCriteria |
| Details |
Midline neck swelling
pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
“comparasion of different neck parameters as the predictive test for difficult tracheal intubation:An observational study.â€
|
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| “comparasion of different neck parameters as the predictive test for difficult tracheal intubation:An observational study.†|
6 month
|
|
|
Target Sample Size
|
Total Sample Size="316"
Sample Size from India="316"
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)
|
11/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The parameters Ratio of height to thyromental distance , Ratio of height to Sternomental distance and Ratio of neck circumference to Thyromental distance will be used preoperatively and find the single best individual parameter in isolation or in combination to predict and anticipated difficult tracheal intubation. |