| CTRI Number |
CTRI/2021/06/034420 [Registered on: 28/06/2021] Trial Registered Prospectively |
| Last Modified On: |
28/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Measurement of volume of tongue using ultrasound to determine difficult laryngoscopy in adult patients undergoing elective surgery |
|
Scientific Title of Study
|
Evaluation of ultrasound guided measurement of tongue volume in predicting difficult laryngoscopy in adult patients undergoing elective surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arpit jain |
| Designation |
Post graduate student |
| Affiliation |
ABVIMS and Dr RML hospital |
| Address |
Department of Anaesthesia
ABVIMS and Dr RML hospital
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
7351561055 |
| Fax |
|
| Email |
jain.arpit093@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof Mohandeep Kaur |
| Designation |
Consultant and HOD Department of Anaesthesia |
| Affiliation |
ABVIMS and Dr RML hospital |
| Address |
Department of Anaesthesia
ABVIMS and Dr RML hospital
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9868952253 |
| Fax |
|
| Email |
mdkaur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arpit jain |
| Designation |
Post graduate student |
| Affiliation |
ABVIMS and Dr RML hospital |
| Address |
Department of Anaesthesia
ABVIMS and Dr RML hospital
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
7351561055 |
| Fax |
|
| Email |
jain.arpit093@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS AND DR RML HOSPITAL NEW DELHI |
|
|
Primary Sponsor
|
| Name |
ABVIMS Dr Ram Manohar Lohia Hospital |
| Address |
Baba Kharak Singh Marg New Delhi 110001 |
| Type of Sponsor |
Government 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 |
| Arpit Jain |
ABVIMS Dr Ram Manohar Lohia Hospital |
Department of Anaesthesia ABVIMS, Dr Ram Manohar Lohia Hospital New Delhi 110001
New Delhi
DELHI |
7351561055
jain.arpit093@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Intervention |
Ultrasound guided measurement of tongue volume. |
For ultrasonographic measurement the patients will be positioned in supine position. They will be instructed to keep there mouth closed and the tongue attached to the floor of the mouth. A 6-13MHz linear ultrasound transducer will be kept under the chin to take the measurements in the midsagittal and transverse plane. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients posted for elective surgery under general anaesthesia requiring endotracheal intubation.
ASA I, II, III |
|
| ExclusionCriteria |
| Details |
Trauma, tumors or deformity of upper airway
Patients with thyroid and neck swelling
Edentulous patients
Pregnant patients
Fracture and deformity of cervical spine |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Ultrasound guided measurement of tongue cross sectional area and tongue width
2.Cormack and lehane grading |
1. Preoperatively
2. During intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of attempts for intubation
2. Time taken for intubation
3. Use of adjunt or alternate technique |
1. During intubation
2. During intubation
3. During intubation |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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)
|
01/07/2021 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a cross sectional observational study in which volume of the tongue will be measured of 81 patients using ultrasound to predict difficult laryngoscopy in adult patients undergoing elective surgery in Dr Ram Manohar Lohia Hospital New Delhi. The primary outcome will be both ultrasound guided measurement of tongue cross sectional area and tongue width and cormack and lehane grading. The secondary outcome will be number of attempts for intubation, requirement of adjunct or alternate technique, and time taken for intubation. |