CTRI Number |
CTRI/2023/04/051792 [Registered on: 19/04/2023] Trial Registered Prospectively |
Last Modified On: |
19/04/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Other |
Public Title of Study
|
ACROMIO-AXILLO-SUPRASTERNAL NOTCH INDEX AS SCREENING TEST TO PREDICT DIFFICULT LARYNGOSCOPY |
Scientific Title of Study
|
An observational study to determine Acromio-Axillo-Suprasternal notch index as screening test to predict difficult laryngoscopy |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
NEETU RENY |
Designation |
Postgraduate |
Affiliation |
KASTURBA MEDICAL COLLEGE |
Address |
Department Of Anaesthesiology
Kasturba Medical College
Manipal Academy Of Higher Education
Manipal
Karnataka Manipal Academy Of Higher Education
Manipal
Karnataka Udupi KARNATAKA 576104 India |
Phone |
8606524256 |
Fax |
|
Email |
neetureny@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR MEGHA T |
Designation |
ASSISTANT PROFESSOR |
Affiliation |
KASTURBA MEDICAL COLLEGE |
Address |
Department Of Anaesthesiology
Kasturba Medical College
Manipal Academy Of Higher Education
Manipal
Karnataka Manipal Academy Of Higher Education
Manipal
Karnataka Udupi KARNATAKA 576104 India |
Phone |
9164694619 |
Fax |
|
Email |
megha.maggidec@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR MEGHA T |
Designation |
ASSISTANT PROFESSOR |
Affiliation |
KASTURBA MEDICAL COLLEGE |
Address |
Department Of Anaesthesiology
Kasturba Medical College
Manipal Academy Of Higher Education
Manipal
Karnataka Manipal Academy Of Higher Education
Manipal
Karnataka Udupi KARNATAKA 576104 India |
Phone |
9164694619 |
Fax |
|
Email |
megha.maggidec@gmail.com |
|
Source of Monetary or Material Support
|
Kasturba Medical College
Manipal Academy Of Higher Education
Manipal
Karnataka |
|
Primary Sponsor
|
Name |
NEETU RENY |
Address |
Kasturba Medical College
Manipal Academy Of Higher Education
Manipal
Karnataka |
Type of Sponsor |
Other [SELF] |
|
Details of Secondary Sponsor
|
Name |
Address |
kasturba medical college |
MANIPAL ACADEMY OF HIGHER EDUCATION
MANIPAL |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Neetu Reny |
Kasturba Medical College |
OT Complex
Kasturba Medical college
Manipal Academy of Higher Education
manipal Udupi KARNATAKA |
8606524256
neetureny@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE-2 |
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 |
undergoing elective under general anaesthesia belonging to American Society of Anaesthesiologists Physical Status I or II will be included in the study. |
|
ExclusionCriteria |
Details |
1.Anatomical abnormalities(limitation of TMJ and Atlanto-axial joint, oral tumors, maxillofacial tumors)
2.Recent Head and Neck surgery
3.Pregnant
4.Edentulous
5.BMI more than 35 Kg/m2
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To determine sensitivity and specificity of acromio-axillo-suprasternal notch index as screening test to predict difficult laryngoscopy |
4 mins after administering Muscle Relaxant |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the predictive values of seven anatomical indices
Modified Mallampatti
Sternomental distance
Thyromental distance
Neck circumference
Ratio of height to thyromental distance
Upper lip bite test
Acromio-axillo-suprasternal notch index
|
4 mins after administering Muscle relaxant |
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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
|
Phase 3 |
Date of First Enrollment (India)
|
25/04/2023 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
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
|
•
Each
patient will undergo physical examination before surgery & airway
assessment tests – Acromio-axillo suprasternal notch index (AASI), Modified Mallampati Test (MMT), Ratio Of
Height to Thyromental Distance (RHTMD), Sternomental distance, Thyromental distance, Neck circumference, Upper
lip bite test will be assessed by the post graduate independent researcher who is not
involved in subsequent study .
•
Patient is shifted to OT after confirming NPO and
taking consent. ASA standard
monitors attached. pre-oxygenation is
done for 3 min with 100% oxygen with all patients receiving analgesic Inj. Fentanyl
2mcg/kg.
•
Induction
will be done with Inj. Propofol 2 mg/kg as starting dose and then subsequently
titrated to loss of eye lash reflex.
•
After
confirming successful bag and mask ventilation, direct laryngoscopy and
tracheal intubation will be facilitated
with depolarising muscle relaxant.
•
With
the head on a standard pillow of height 7cm and in the sniffing position,
direct laryngoscopy was performed with Macintosh laryngoscope blade 3 by an
anaesthesiologist with more than 2 years of experience. The
laryngeal view was graded according to the Cormack and Lehane grading system . PG who had
assessed the parameter preoperatively will note down the findings.
•
Total number of intubation attempts, number of involved
anaesthesiologists, alternate techniques used, requirement of additional
lifting force, laryngeal pressure applied, vocal cord mobility is noted down . |