CTRI Number |
CTRI/2023/05/052532 [Registered on: 11/05/2023] Trial Registered Prospectively |
Last Modified On: |
29/04/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Prospective observational |
Study Design |
Other |
Public Title of Study
|
Comparison of two anatomical landmark techniques for predicting difficult airway in patients undergoing cancer surgeries |
Scientific Title of Study
|
A Prospective observational study to determine the role of Ratio of Height to Thyromental Distance(RHTMD) and Ratio of Height to Sternomental Distance(RHSMD) in predicting difficult airway in patients undergoing elective oncosurgeries under general anaesthesia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Deepthi J Prabhu |
Designation |
Associate professor |
Affiliation |
Regional Cancer Centre |
Address |
Department of Anaesthesiology
Regional Cancer Centre
Thiruvananthapuram
Thiruvananthapuram KERALA 695019 India |
Phone |
9895006045 |
Fax |
|
Email |
drdeepthiprabhu@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Deepthi J Prabhu |
Designation |
Associate professor |
Affiliation |
Regional Cancer Centre |
Address |
Department of Anaesthesiology
Regional Cancer Centre
Thiruvananthapuram
KERALA 695019 India |
Phone |
9895006045 |
Fax |
|
Email |
drdeepthiprabhu@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Deepthi J Prabhu |
Designation |
Associate professor |
Affiliation |
Regional Cancer Centre |
Address |
Department of Anaesthesiology
Regional Cancer Centre
Thiruvananthapuram
KERALA 695019 India |
Phone |
9895006045 |
Fax |
|
Email |
drdeepthiprabhu@gmail.com |
|
Source of Monetary or Material Support
|
REGIONAL CANCER CENTRE,TRIVANDRUM |
|
Primary Sponsor
|
Name |
Nil |
Address |
Not applicable |
Type of Sponsor |
Other [] |
|
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 Deepthi J Prabhu |
Regional Cancer Centre |
Department of Anaesthesiology,Regional Cancer Centre
Medical college kumarapuram road,Medical college campus,chalakkuzhi,695011 Thiruvananthapuram KERALA |
9895006045
drdeepthiprabhu@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Human 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 |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA physical status 1,2
undergoing elective oncosugeries under general anaesthesia |
|
ExclusionCriteria |
Details |
Restricted neck mobility
Major airway abnormalities
Tumors or mass in the neck or airway
Post burn neck contractures
Pregnancy
Kyphoscoliosis
Obesity(BMI >30) |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Predicts difficult airway, can avoid intraop unanticipated difficult airway related complications |
1 year |
|
Secondary Outcome
|
Outcome |
TimePoints |
Predicts difficult airway |
6 months |
|
Target Sample Size
|
Total Sample Size="193" Sample Size from India="193"
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)
|
15/05/2023 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
On the preoperative day, patient’s airway will be assessed, which includes Mallampatti grading, Thyromental Distance, Sternomental Distance, height,weight, neck mobility. Ratio of height to thyromental distance ( RHTMD)and ratio of height to sternomental distance (RHSMD)will be calculated. In the operation theatre, the baseline vitals of the patient like spo2,PR, BP,ECG will be recorded.Then patients will receive premedication with midazolam and Glycopyrrolate followed by preoxygenation with 100% oxygen.Anesthesia will be induced with propofol 1- 2mg/kg and muscle relaxation with vecuronium 0.1mg/kg as done routinely. Intubation will be carried out by an anesthesiologist with more than 5 years experience and who is blinded to the study.The glottis exposure on direct laryngoscopy will be graded as per routine. Intubation will be considered difficult if view on laryngoscopy is Cormack Lehane 3 or 4, >3 attempts at intubation, duration > 10min,or if stylets,bougie, video laryngoscopy or fibreoptic bronchoscope used.The preoperative airway assessment data and findings during intubation will be assessed and correlated to establish the incidence of difficult intubation. The ability of RHTMD and RHSMD to predict difficult airway preoperatively in patients actually found to have difficult laryngoscopy and intubation will also be studied.
|