| CTRI Number |
CTRI/2024/12/078149 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
AN OBSERVATIONAL PROSPECTIVE STUDY TO DETERMINE THE POTENTIAL OF THYROMENTAL HEIGHT TEST COMPARED TO OTHER METHODS IN PREDICTING DIFFICULT AIRWAY FOR OBESE PATIENTS POSTED FOR ELECTIVE SURGERY THAT REQUIRES INTUBATION |
|
Scientific Title of Study
|
EVALUATING THE POTENTIAL OF THYROMENTAL HEIGHT TEST COMPARED TO CONVENTIONAL METHODS FOR PREDICTING DIFFICULT AIRWAY IN OBESE PATIENTS POSTED FOR ELECTIVE SURGERY UNDER GENERAL ANAESTHESIA AN OBSERVATIONAL COMPARATIVE 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 JENIN ARUL BENEDICT MICHAEL |
| Designation |
JUNIOR RESIDENT-2 |
| Affiliation |
GRANT MEDICAL COLLEGE AND SIR JJ HOSPITAL |
| Address |
300 RESIDENT HOSTEL , ROOM 615, SIXTH FLOOR, GRANT MEDICAL COLLEGE AND SIR JJ HOSPITAL, BYCULLA,
MUMBAI.
MAHARASTRA,
INDIA
Mumbai
MAHARASHTRA
400008
India |
| Phone |
7806873312 |
| Fax |
|
| Email |
michaeljenin1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUKRITI ATRAM |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GRANT MEDICAL COLLEGE AND SIR JJ HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
GRANT MEDICAL COLLEGE AND SIR JJ HOSPITAL, BYCULLA,
MUMBAI,
MAHARASTRA,
INDIA
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9004083034 |
| Fax |
|
| Email |
sukritiatram@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR SUKRITI ATRAM |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GRANT MEDICAL COLLEGE AND SIR JJ HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
GRANT MEDICAL COLLEGE AND SIR JJ HOSPITAL, BYCULLA,
MUMBAI,
MAHARASTRA,
INDIA
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9004083034 |
| Fax |
|
| Email |
sukritiatram@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY,
GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL,
BYCULLA,
MUMBAI 400008 |
|
|
Primary Sponsor
|
| Name |
JENIN ARUL BENEDICT MICHAEL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL,BYCULLA ,MUMBAI 400008 |
| 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 JENIN ARUL BENEDICT MICHAEL |
DEPARTMENT OF ANAESTHESIOLOGY |
6TH FLOOR,MAIN BUILDING
GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL
JJ MARG
BYCULLA
MUMBAI MAHARASTRA 400008
Mumbai
MAHARASHTRA |
7806873312
michaeljenin1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE OF ETHICS COMMITEE, GRANT GOVERNMENT MEDICAL COLLEGE, MUMBAI 400008 |
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
|
| Type |
Name |
Details |
| Comparator Agent |
INTER INCISOR GAP |
INTER INCISOR GAP IS MEASURED WITH THE MOUTH OPEN MAXIMALLY, IT MEASURES THE DISTANCE BETWEEN THE INCISORS OR ALVEOLAR MARGINS
|
| Comparator Agent |
MALLAMPATI SCORE |
THE ASSESSMENT IS DONE WITH THE PATIENT SEATED UPRIGHT WITH THEIR MOUTH OPEN AND TONGUE PROTRUDED, AND THE EXAMINER LOOKS TO SEE WHAT STRUCTURES OF THE OROPHARYNX CAN BE VISUALIZED. THE LESS OBSTRUCTED THESE STRUCTURES ARE, THE LOWER THE MALLAMPATI SCORE. |
| Comparator Agent |
NECK CIRCUMFERENCE |
COMPARING THE USE OF THYROMENTAL HEIGHT DISTANE WITH OTHER CONVENTIONAL TOOLS OF DIFFICULT AIRWAY LIKE NECK CIRCUMFERENCE, MODIFIED MALLAMPATI SCORE AND NECK CIRCUMFERENCE/TMHT RATIO, INTER INCISOR GAP TEST |
| Intervention |
THYROMENTAL HEIGHT TEST |
IT MEASURES THE HEIGHT BETWEEN ANTERIOR BORDER OF MENTUM AND THYROID CARTILAGE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENT WHO REQUIRES GENERAL ANESTHESIA WITH ENDOTRACHEAL TUBE INTUBATION USING DIRECT LARYNGOSCOPY
PATIENTS WHO ARE CLASSIFIED WITH ASA GRAADE I OR II
PATIENTS WHO ARE CLASSIFIED WITH BMI GREATER THAN OR EQUAL TO 25 |
|
| ExclusionCriteria |
| Details |
PATIENT WITH NEUROMUSCULAR OR CRANIOFACIAL ABNORMALITIES WHO REQUIRE AWAKE INTUBATION
PATIENTS WHO ARE UNWILLING TO PARTICIPATE IN THE STUDY
PATIENTS WITH BMI LESS THAN 25 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IMPLEMENTING THE USE OF THYROMENTAL HEIGHT DISTANCE AS A PART OF PRE-ANAESTHETIC EVALUATION AND CONFIRMING THE UTILITY IN CLINICAL PRACTICE BY CORRELATING WITH DIFFICULT AIRWAY,CLASSIFIED WITH CL GRADE OF EQUAL OR MORE THAN 3 USING CONVENTIONAL DIFFICULT LARYNGOSCOPY. |
NA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| COMPARING THE USE OF THYROMENTAL HEIGHT DISTANE WITH OTHER CONVENTIONAL TOOLS OF DIFFICULT AIRWAY LIKE NECK CIRCUMFERENCE, MODIFIED MALLAMPATI SCORE AND NECK CIRCUMFERENCE/TMHT RATIO, INTER INCISOR GAP TEST |
NA |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
01/01/2025 |
| 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="0"
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 aims to assess the validity of TMHT as a predictor of Difficult Laryngoscopy View, Difficult laryngoscopy is inability to view the glottis opening using a conventional curve blade laryngoscope, corresponding to a Cormack and Lehane III or IV grade view, in which only epiglottis or only pharynx and tongue, respectively, may be visualized is being evaluated in obese surgical patients. |