| CTRI Number |
CTRI/2023/04/051981 [Registered on: 26/04/2023] Trial Registered Prospectively |
| Last Modified On: |
24/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A STUDY TO MEASURE A PARAMETER IN NECK TO HELP IDENTIFY THE DIFFICULT LEVEL TO PUT BREATHING TUBE BEFORE SURGERY |
|
Scientific Title of Study
|
A STUDY OF ACROMIOAXILLO SUPRASTERNAL NOTCH INDEX (AASI) TO PREDICT DIFFICULT VISUALIZATION OF LARYNX |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MOHAN KUMAR K S |
| Designation |
POST GRADUATE |
| Affiliation |
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA, DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, KADUGONDANAHALLI, BANGALORE 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9538350911 |
| Fax |
|
| Email |
drmohankote@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANTOSH KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA, DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, KADUGONDANAHALLI, BANGALORE 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9845785715 |
| Fax |
|
| Email |
drsantoshkumarcc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MOHAN KUMAR K S |
| Designation |
POST GRADUATE |
| Affiliation |
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA, DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, KADUGONDANAHALLI, BANGALORE 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9538350911 |
| Fax |
|
| Email |
drmohankote@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, KADUGONDANAHALLI, BANGALORE 560045 |
|
|
Primary Sponsor
|
| Name |
DR MOHAN KUMAR K S |
| Address |
OT COMPLEX, DEPARTMENT OF ANAESTHESIA, DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, BANGALORE 560045 |
| 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 |
| DR MOHAN KUMAR K S |
DR B R AMBEDKAR MECIAL COLLEGE AND HOSPITAL |
OT COMPLEX, DEPARTMENT OF ANAESTHESIOLOGY, DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, KADUGONDANAHALLI, BANGALORE 560045
Bangalore
KARNATAKA |
9538350911
drmohankote@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMITTEE DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to American Society of Anesthesiologists’ physical status (ASA PS) I and II.
|
|
| ExclusionCriteria |
| Details |
Patients with clinically predicted difficult airway,
Patients with body mass index >30 kg/m2,
Obstetric patients,
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the usefulness of Acromioaxillo Suprasternal Notch Index (AASI) for predicting the difficult visualization of larynx during endotracheal intubation in patients undergoing general anaesthesia as assessed by Cormack – Lehane grading. |
Preoperative period and during endotracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare Acromioaxillo Suprasternal Notch Index (AASI) with other predictors of difficult airway like Modified Mallampati (MMP) score, sternomental distance (SMD), thyromental distance (TMD) and neck circumference. |
Preoperative period and during endotracheal intubation |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
05/05/2023 |
| 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="6"
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
|
After obtaining
approval from the Institutional Ethics Committee and written informed consent
will be taken from the eligible patients with American
Society of Anesthesiologists’ physical status (ASA PS) I and II
scheduled to undergo elective surgery requiring endotracheal intubation will be
enrolled in this prospective observational single-centre study. Each patient
will be assessed before surgery for AASI. During endotracheal intubation the
best laryngoscopy view will be noted according to the Cormack – Lehane (CL)
grading system.
|