| CTRI Number |
CTRI/2025/03/082452 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
CLINICAL STUDY TO COMPARE BEDSIDE TEST MALLAMPATI SCORE, UPPER LIP
BITE AND THYROMENTAL DISTANCE WITH CORMACK LEHANE |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF MALLAMPATI SCORE, UPPER LIP
BITE AND THYROMENTAL DISTANCE TO PREDICT DIFFICULT INTUBATION WITH CORMACK LEHANE SCORE |
| 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 Urmila Keshari |
| Designation |
Professor in dept of anesthesiology |
| Affiliation |
GANDHI MEDICAL COLLEGE AND ASSOCIATED HOSPITAL,BHOPAL,MP |
| Address |
Operation theatre ,2nd floor dept of anaesthesiology ,
Gandhi medical college
Bhopal
Madhya Pradesh
462001
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9826757745 |
| Fax |
|
| Email |
drsurmi@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr Sherin Soni |
| Designation |
Professor in dept of anesthesiology |
| Affiliation |
GANDHI MEDICAL COLLEGE BHOPAL |
| Address |
Operation theatre ,2nd floor dept of anaesthesiology ,
Gandhi medical college
Bhopal
Madhya Pradesh
462001
gandhi medical college,hamidia hospital
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9827822660 |
| Fax |
|
| Email |
sherinsoni9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RICHA PANDEY |
| Designation |
dept of anesthesiology |
| Affiliation |
GANDHI MEDICAL COLLEGE BHOPAL |
| Address |
Operation theatre ,2nd floor dept of anaesthesiology ,
Gandhi medical college
Bhopal
Madhya Pradesh
462001
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9669047145 |
| Fax |
|
| Email |
richathepride@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gandhi medical college and associated hospital,Bhopalmadhya pradesh, 462001 |
|
|
Primary Sponsor
|
| Name |
Gandhi medical college |
| Address |
Gandhi medical college Bhopal Madhya Pradesh,462001 |
| 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 Sherin Soni |
Gandhi medical college |
2nd floor operation theatre,gandhi medical college,hamidia hospital, bhopal
Bhopal
MADHYA PRADESH |
9827822660
sherinsoni9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K253||Acute gastric ulcer without hemorrhage or perforation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dr. Sherin soni |
Pg resident
Dept of anaesthesia
Gandhi medical college Bhopal
Madhya pradesh |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
elective surgery
under general anaesthesia with endotracheal intubation for various
surgeries (abdominal, gynecological , obstetric, urological, neuro-surgery,
eye, orthopedic, ENT and plastic surgeries), age=18 -60years ,ASA physical
status Class I–II. |
|
| ExclusionCriteria |
| Details |
Patient refusal
Obese
Pregnant
Asa> 2
Difficult airway |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| no single test correctly predicts all cases of difficult intubation |
4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any clinical test that is used for prediction of these difficult airways should be quick, simple, convenient, & practical. Unfortunately, there is still no individual test, or combination of tests, with 100% sensitivity (i.e., no false negatives) & 100% speci- ficity (i.e., no false positives |
4 weeks & 8 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/03/2025 |
| 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 Yet Recruiting |
| 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
|
Difficult airway is the one where the process of induction of
anesthesia and intubation of
trachea can be potentially life
threatening and can cause the delay or failure of intubation ,which significantly increases the morbidity and
mortality of general anesthesia.[1]
Up to around 30% of
anesthetic deaths are due to a compromised airway.[2]
The major role of an anesthesiologist is to anticipate
difficult airway and to maintain a
patent airway and gas exchange and avoid any complications related to
intubation .Unanticipated difficult intubations are major concern .The identification of patients with difficult airways is very crucial during preoperative evaluations [3]
There are several test that
can be done to identify patients with difficult airways, which includes from
basic tests to more advanced test.Many
studies have been done to perform some bedside tests that are quick , easy to perform and no need of any special equipment.These bedside tests play a vital role during preoperative
examination, anticipate the risk and identify the patients with potential
difficult intubation to avoid complications.
|