| CTRI Number |
CTRI/2024/05/068089 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the assessment of difficult airway based on MMP grading in supine and sitting position |
|
Scientific Title of Study
|
Evaluation of effect of supine posture and phonation on modified mallampati grade and its applicability in prediction of difficult airway |
| 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 nandita kad |
| Designation |
Professor |
| Affiliation |
Department of anaesthesiology and critical care |
| Address |
Department of anaesthesiology and critical care
Pt BD Sharma PGIMS Rohtak.
Department of anaesthesiology and critical care
Pt BD sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9896335544 |
| Fax |
|
| Email |
kadnandita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr nandita kad |
| Designation |
Professor |
| Affiliation |
Department of anaesthesiology and critical care |
| Address |
Department of anaesthesiology and critical care
Pt BD Sharma PGIMS Rohtak
Department of anaesthesiology and critical care
Pt BD Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9896335544 |
| Fax |
|
| Email |
kadnandita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishal verma |
| Designation |
PG student |
| Affiliation |
Department of anaesthesiology and critical careare |
| Address |
Department of anaesthesiology and critical care
Pt BD Sharma PGIMS Rohtak
Department of anaesthesiology and critical care
Pt BD Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7988141059 |
| Fax |
|
| Email |
dr.vermavishal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology and critical care, Pt BD sharma PGIMS, Rohtak 124001 haryana india |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology and critical care Pt BD Sharma PGIMS Rohtak |
| Address |
Department of anaesthesiology Pt BD Sharma PGIMS Rohtak 124001 Haryana India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Pgims rohtak |
Pgims rohtak |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishal verma |
Pt BD sharma PGIMS Rohtak |
Department of anaesthesiology and critical care
Modular OT complex
Rohtak
HARYANA |
7988141059
dr.vermavishal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics Committee pgims rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
Patients who are undergoing surgeries under general anaesthesia.
Etc |
|
| ExclusionCriteria |
| Details |
Patients who can not sit.
Patients who are having upper airway pathology
Etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the effect of supine position and phonation on MPG |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To predict difficult airway |
1 year |
|
|
Target Sample Size
|
Total Sample Size="103"
Sample Size from India="103"
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)
|
02/07/2024 |
| 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="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
|
Modified mallampati test is simplest test to access airway which is done in sitting position. In cases like burns n spine injury patients it is not possible to make them sit. So we plan to this study to know the effects of supine position and phonation on MPG |