| CTRI Number |
CTRI/2024/06/068232 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic
Process of Care Changes |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Prediction of difficult laryngoscopy and intubation using ultrasound parameters |
|
Scientific Title of Study
|
Validation of ultrasound guided parameters as a predictor of difficult laryngoscopy and intubation - A comparative analysis |
| 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 Aditi Verma |
| Designation |
Post Graduate Student |
| Affiliation |
NSCB Medical College, Jabalpur |
| Address |
First floor, Department of Anaesthesiology, NSCB Medical College, Tilwara road, Jabalpur MP 482003
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
|
| Fax |
|
| Email |
22aditi.verma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayank Chansoria |
| Designation |
Head of department |
| Affiliation |
NSCB Medical College, Jabalpur |
| Address |
Department of Emergency Medicine, NSCB Medical College, Tilwara road, Jabalpur MP 482003
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
7049079825 |
| Fax |
|
| Email |
mayankchansoria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayank Chansoria |
| Designation |
Head of department |
| Affiliation |
NSCB Medical College, Jabalpur |
| Address |
Department of Emergency Medicine, NSCB Medical College, Tilwara road, Jabalpur MP 482003
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
7049079825 |
| Fax |
|
| Email |
mayankchansoria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Netaji Subhash Chandra Bose Medical College Hospital, Tilwara Road, Medical College Colony, Jabalpur, Madhya Pradesh, India, 482003 |
|
|
Primary Sponsor
|
| Name |
Dr Aditi Verma |
| Address |
First floor, Department of Anaesthesiology, NSCB Medical College, Tilwara road, Jabalpur MP 482003 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Dr Mayank Chansoria |
Netaji Subhash Chandra Bose Medical College Hospital Jabalpur |
First floor, Department of Anaesthesiology, NSCB Medical College, Tilwara road, Jabalpur MP 482003
Jabalpur
MADHYA PRADESH |
7049079825
mayankchansoria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE JABALPUR (MP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cormack Lehane grading |
Actual difficulty in laryngoscopy and intubation analysed by Cormack Lehane grading |
| Intervention |
Ultrasound guided airway assessment |
Prediction of difficult laryngoscopy and intubation using ultrasound parameters |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing elective surgeries under GA
Patient with ASA physical status grade I, II
|
|
| ExclusionCriteria |
| Details |
Patients posted for obstetric surgeries.
Patient with distorted anatomy (due to trauma, neck contractures, etc.)
Patient with visible neck/ cervical spine mass
Patient with restricted neck flexion/extension
Patient with restricted mouth opening/ jaw movement
Patients with intraoral/ extraoral pathologies predicting difficult laryngoscopy and intubation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| correlation of ultrasound parameters of difficult laryngoscopy with actual difficult laryngoscopy and intubation scenarios in operation theatre |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare USG parameters with Cormack Lehane grading in prediction of difficult laryngoscopy
|
30 minutes |
| To use USG parameters to predict difficult intubation using attempts of intubation as a guide |
30 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/06/2024 |
| 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="1"
Months="0"
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
|
A prospective study will be conducted in a tertiary care hospital after clearance from ethics committee & Institutional Review Board. 100 patients will be enrolled who fulfill inclusion criteria for the study. Patients included will be those who undergo general anaesthesia for elective non-obstetric surgeries with ASA Physical status I or II, with age between 18 & 65years. Airway evaluation for the enrolled patients will be done at Pre- anaesthetic check-up clinic after taking consent. Ultrasound machine will be used to examine following parameters and the measurements will be noted in a tabular format as difficult laryngoscopy/ intubation predicted or not. 1. Skin to epiglottis 2. Thickness of base of tongue 3. skin to hyoid distance 4. skin to vocal cords 5. hyo-mental distance
On the basis of the above parameters, patients would be divided into two groups, Group AI – Easy laryngoscopy Group AII – Difficult laryngoscopy These groups would be compared with Cormack Lehane grading, where Grade I, II will be grouped as easy laryngoscopy and III, IV as difficult. Group BI – Easy laryngoscopy Group BII – Difficult laryngoscopy |