| CTRI Number |
CTRI/2024/04/065601 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF RESPIRATORY CYCLE ON MODIFIED MALLAMPATI CLASSIFICATION (A CLASSIFICATION HELPING IN PREDICTING DIFFICULT INTUBATION)IN ADULTS |
|
Scientific Title of Study
|
EFFECT OF RESPIRATORY CYCLE ON MODIFIED MALLAMPATI CLASSIFICATION IN ADULTS |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanuj |
| Designation |
PG RESIDENT |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
ground floor, Main OT building, Department of Anaesthesia & Intensive care, Safdarjung hospital Delhi
South West
DELHI
110029
India |
| Phone |
9311521933 |
| Fax |
|
| Email |
drtanujvmmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Bamba |
| Designation |
Professor & Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
ground floor, Main OT building, Department of Anaesthesia & Intensive care, Safdarjung hospital Delhi
South West
DELHI
110029
India |
| Phone |
9811270511 |
| Fax |
|
| Email |
charu.bamba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charu Bamba |
| Designation |
Professor & Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
ground floor, Main OT building, Department of Anaesthesia & Intensive care, Safdarjung hospital Delhi
South West
DELHI
110029
India |
| Phone |
9811270511 |
| Fax |
|
| Email |
charu.bamba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi-110029, India |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College & Safdarjung Hospital |
| Address |
Safdarjung Hospital, New Delhi-110029 |
| 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 Tanuj |
VARDHMAN MAHAVIR MEDICAL COLLEGE & SAFDARJUNG HOSPITAL |
PAC room, ground floor, Main OT building, Department of Anaesthesia, Safdarjung hospital New Delhi-110029
South West
DELHI |
9311521933
drtanujvmmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE |
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 |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged between 18-65 years posted for surgeries under general anesthesia requiring
endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
PREGNANT PATIENTS
PATIENTS WITH INTER INCISOR GAP LESS THAN 2.5cm
PATIENTS WHO ARE NOT ABLE TO FOLLOW COMMANDS
PATIENTS OF OBSTRUCTIVE SLEEP APNOEA
PATIENTS WITH BMI MORE THAN 25 KG/M2
PATIENTS WITH ORO-PHARYNGEAL PATHOLOGY |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the effect of respiratory cycle on Modified Mallampati Classification in adults. |
To find the effect of respiratory cycle on Modified Mallampati Classification in adults. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Cormack & Lehane grading during laryngoscopy & compare with Modified Mallampati Class. |
This will be done while patient is taken into the operation theatre. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/05/2024 |
| 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="6"
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
|
MMP classification is widely used by Anaesthetist for assessing upper airway and predicting difficult airway during pre-anesthetic check-up. Many factors have impact on MMP CLASS. Once such factor is Respiratort cycle. Many studies have been conducted in past with respect to other factors like effect of phonation, position etc but there is very literature available in context of effect of respiratory cycle. So we decided to conduct a study on effect of respiratory cycle on MMP class. |