| CTRI Number |
CTRI/2024/04/065487 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
07/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective, comparative, double blinded |
| Study Design |
Other |
|
Public Title of Study
|
A study of prediction of difficult visualization of larynx by comparing airway assessement tests. |
|
Scientific Title of Study
|
Comparison of newer airway assessement tests- upper lip bite test (ULBT), ratio of height to thyromental distance (RHTMD), thyromental height test (TMHT), and acromio-axillo suprasternal notch index(AASI) for visualization of larynx in geriatric population: A prospective, observational study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arvind Khare |
| Designation |
Senior Professor |
| Affiliation |
JLN medical college and hospital, Ajmer |
| Address |
Department of anaesthesiology, new OT, 1st floor, JLN hospital, kalabagh, Ajmer
Ajmer RAJASTHAN 305001 India |
| Phone |
9414306114 |
| Fax |
|
| Email |
arvindkhare68@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arvind Khare |
| Designation |
Senior Professor |
| Affiliation |
JLN medical college and hospital, Ajmer |
| Address |
Department of anaesthesiology, new OT, 1st floor, JLN hospital, kalabagh, Ajmer
RAJASTHAN 305001 India |
| Phone |
9414306114 |
| Fax |
|
| Email |
arvindkhare68@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Arvind Khare |
| Designation |
Senior Professor |
| Affiliation |
JLN medical college and hospital, Ajmer |
| Address |
Department of anaesthesiology, new OT, 1st floor, JLN hospital, kalabagh, Ajmer
RAJASTHAN 305001 India |
| Phone |
9414306114 |
| Fax |
|
| Email |
arvindkhare68@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology,New OT, 1st floor, JLN Hospital,Kalabagh, Ajmer, Rajasthan 305001 |
|
|
Primary Sponsor
|
| Name |
JLN medical college |
| Address |
New OT, 1st floor,Kalabagh, Ajmer, Rajathan,305001 |
| 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 Pankaj Swami |
JLN medical college and hospital |
Department of anaesthesiology, new OT,1st floor, JLN hospital, Kalabagh Ajmer RAJASTHAN |
7891071516
drpksmbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethecal committee Jawarlal Nehru medical college, Ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z048||Encounter for examination and observation for other specified reasons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
BMI less then thirty kilogram per meter square
ASA physical status first and second
Schedule for elective surgery under general anesthesia requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Obvious anatomical abnormality
Recent head and neck surgery
Disability to open the mouth
Upper airway abnormality
Cervical spine injury
Neck mass
Temporo-mandibular joint ankylosis
Facial and tongue anomalies
History of obstructive sleep apnea
BMI more then and equal to thirty kilogram per meter square
ASA physical status third and above
Edentolous |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of acromio-axillo suprasternal notch index test for prediction of difficult visualization of larynx |
Base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparison of acromio-axillo suprasternal notch index with other bedside test such as upper lip bite test, ratio of height to thyromental distance, thyromental height test for prediction of difficult visualization of larynx |
Base line |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
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)
|
18/04/2024 |
| 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="8" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
study will be a prospective, comparative, double blinded, observational study.
Patients will be included, age more then 60 years, of either sex, BMI < 30 kg/m2, ASA physical status
I and II and schedule for elective surgery under general anaesthesia requiring
endotracheal intubation. Aim is comparison of newer airway assessment tests
include acromio-axillo suprasternal notch index (AASI), upper lip bite test (ULBT),
ratio of height to thyromental distance (RHTMD), thyromental height test (TMHT)
and for prediction of difficult visualization of larynx (DVL) in geriatric
population.
Primary
objective is to evaluate the efficacy of AASI (sensitivity, specificity, positive
predictive value, negative predictive value and diagnostic accuracy) for
prediction of DVL preoperative and secondary objective is to compare AASI with other bedside tests such as ULBT, RHTMD and
TMHT for prediction of DVL and correlation of above assessment tools with
modified Cormack - Lehane grading (MCLG) for glottic visualization.
All the patients will be subjected to detailed
history, complete physical as well as systemic examination before surgery in
preoperative checkup. Patient’s required parameters, routine and all relevant
investigations will be checked. The purpose and protocol of the study will be
explained to the patients and informed written consent will be obtained.
In
the operating room a standardized
anesthesia technique will be followed to give anaesthesia to patient. Laryngoscopy
will be performed and the laryngoscopic view will be graded using MCLG grading.
All the parameter will be recorded and documented and analyzed using standard qualitative
and quantitative test. |