CTRI Number |
CTRI/2021/04/033129 [Registered on: 26/04/2021] Trial Registered Prospectively |
Last Modified On: |
26/07/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Different methods for prediction of difficult mask holding and insertion of tube in breathing pipe |
Scientific Title of Study
|
Evaluation of Acromio-axillo-suprasternal notch index, upper lip bite test and ratio of height to thyromental distance for prediction of difficult mask ventilation and difficult intubation |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Prerana Nirav Shah |
Designation |
Professor (Additional) |
Affiliation |
GSMC & KEMH |
Address |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India
Mumbai
MAHARASHTRA
400012
India
Mumbai MAHARASHTRA 400012 India |
Phone |
9869117027 |
Fax |
|
Email |
pps@kem.edu |
|
Details of Contact Person Scientific Query
|
Name |
Swekchha Jain |
Designation |
Resident |
Affiliation |
GSMC & KEMH |
Address |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India
Mumbai
MAHARASHTRA
400012
India
Mumbai MAHARASHTRA 400012 India |
Phone |
8770028931 |
Fax |
|
Email |
swekchha0401.jain@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Swekchha Jain |
Designation |
Resident |
Affiliation |
GSMC & KEMH |
Address |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India
Mumbai
MAHARASHTRA
400012
India
MAHARASHTRA 400012 India |
Phone |
8770028931 |
Fax |
|
Email |
swekchha0401.jain@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India |
|
Primary Sponsor
|
Name |
GSMC KEMH |
Address |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India |
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 |
SWEKCHHA JAIN |
GSMC KEMH |
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA |
8770028931
SWEKCHHA0401.JAIN@GMAIL.COM |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee IEC-IIi |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1) Age: 18-65 years
2) Patients of both genders
3) Patients undergoing all kind of elective surgeries under general anaesthesia requiring endotracheal intubation
4) American Society of Anesthesiologists grade I and II
|
|
ExclusionCriteria |
Details |
1) Patients not willing to participate in study.
2) Patients with insitu endotracheal tube.
3) Pregnant women
4) Patients with neck burns contracture, and history of neck surgery
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Evaluation of Acromio-axillo-suprasternal notch index ( AASI), upper lip bite test ( ULBT) and ratio of height to thyromental distance (RHTMD) for predicting difficult mask ventilation and difficult intubation. |
Day prior to surgery
This is baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
• Duration of laryngoscopy,
• Duration of intubation and
• Number of attempts for successful intubation
|
On day of surgery |
Duration of laryngoscopy
Duration of intubation
Number of attempts for successful intubation |
On day of surgery.
|
|
Target Sample Size
|
Total Sample Size="194" Sample Size from India="194"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
30/04/2021 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Airway
assessment before any type of anaesthesia is mandatory. Failure to maintain a
patent airway after induction of anaesthesia leads to irrevocable catastrophic
sequelae such as brain damage or death. Maintaining a patent airway is
essential for adequate oxygenation and ventilation and failure to do so, even
for a brief period of time, can be life threatening that significantly
increases the morbidity and mortality of general anaesthesia. Ability to
ventilate the patient with bag and mask is extremely important in the
unfortunate scenario of inability to intubate. We find that intubation may be
easy even though mask ventilation is difficult. There are many bed side tests
to assess difficult airway and mask ventilation which are easy to perform and
need no special equipment. But all these tests have limitations and no single
one is complete. No single airway test can provide a high index of sensitivity
and specificity for prediction of difficult airway. Therefore, it has to be a
combination of multiple tests.
The
primary aim of this study is to evaluate acromio-axillo-suprasternal notch
index, upper lip bite test and ratio of height to thyromental distance for
prediction of difficult mask ventilation and difficult intubation. |