| CTRI Number |
CTRI/2023/06/053576 [Registered on: 06/06/2023] Trial Registered Prospectively |
| Last Modified On: |
04/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational single blinded study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study use of ultrasonography to measure airway indices to predict difficult laryngoscopy. |
|
Scientific Title of Study
|
Predicting difficult laryngoscopy using ultrasonographic airway indices- prospective,observational, single blinded study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prachi Hanumant Mungi |
| Designation |
Junior Resident |
| Affiliation |
Goa Medical College |
| Address |
Department of Anesthesiology Goa Medical College Bambolim
North Goa
Bambolim Goa
North Goa
GOA
403401
India |
| Phone |
9657554348 |
| Fax |
|
| Email |
prachimungi96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirley Ann DSouza |
| Designation |
Professor and Head of the Department |
| Affiliation |
Goa Medical College |
| Address |
Department of Anesthesiology Goa Medical College Bambolim
North Goa
North Goa
GOA
403202
India |
| Phone |
9822159170 |
| Fax |
|
| Email |
shirley_dsouza05@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachi Hanumant Mungi |
| Designation |
Junior Resident |
| Affiliation |
Goa Medical College |
| Address |
Department of Anesthesiology Goa Medical College Bambolim
North Goa
Bambolim Goa
North Goa
GOA
403401
India |
| Phone |
9657554348 |
| Fax |
|
| Email |
prachimungi96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goa Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Goa Medical College |
| Address |
Goa Medical College
Bambolim
Tiswadi
North Goa
Goa
403201 |
| 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 |
| Dr Prachi Hanumant Mungi |
Goa Medical College and Hospital |
Lower Operation Theatre
Upper Operation Theatre
North Goa
GOA |
9657554348
prachimungi96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: X||New Technology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-III patients
Undergoing general anesthesia for elective surgery
Age 18-90 years
Informed consent |
|
| ExclusionCriteria |
| Details |
Body mass index greater than or equal to 30kg per metre square
Pregnancy
Neck swelling
History of radiation therapy to neck
Maxillofacial or cervical abnormalities
Restricted mouth opening
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified Cormack-Lehane
Grade 1 to 2a Easy laryngoscopy
Grade 2b to 4 Difficult laryngoscopy
Grade 2b |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Easy laryngoscopy: Cormack-lehane grade 1 to 2a
Difficult laryngoscopy: Cormack-lehane grade 2b-4a |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
15/06/2023 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Preanesthetic check-up and clinical assessment of airway will be done.
Consultant Anaesthesiology will perform 2D USG of the airway with patient in supine, sniffing position using ultrasonography linear probe of 6-13MHz.
Distance Between Skin and hyoid bone (DSHB) and Between Skin and epiglottis DSE) will be measured in transverse plane. After complete evaluation general anesthesia is induced with propofol (2-2.5mg/kg), fentanyl (2-4mcg/kg) and vecuronium (0.08-0.1mg/kg).
o After verifying adequate neuromuscular relaxation direct laryngoscopy using Macintosh blade will be performed in sniffing position to evaluate Cormack-Lehane grade followed by tracheal intubation. Patient will be assessed for Easy laryngoscopy- Grade 1-2a
Difficult laryngoscopy- Grade 2b-4
Number of intubation attempts/ intubation aids/ Need for difficult intubation approach or invasive approach will be noted.
|