| CTRI Number |
CTRI/2024/02/062216 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Comparision of different airway assessment methods in predicting difficult intubation |
|
Scientific Title of Study
|
A Comparision of different airway assessment methods in predicting difficult intubation: Lower jaw protrusion maneuver and neck extension versus thyromental distance and modified mallampatti test |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunkesula Sonia Begum |
| Designation |
Assistant professor |
| Affiliation |
government medical college, kadapa |
| Address |
Department of anesthesiology
Government medical college
Kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
8897573489 |
| Fax |
|
| Email |
sonia.sunkesula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunkesula Sonia Begum |
| Designation |
Assistant professor |
| Affiliation |
government medical college, kadapa |
| Address |
Department of anesthesiology
Government medical college
Kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
8897573489 |
| Fax |
|
| Email |
sonia.sunkesula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sunkesula Sonia Begum |
| Designation |
Assistant professor |
| Affiliation |
government medical college, kadapa |
| Address |
Department of anesthesiology
Government medical college
Kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
8897573489 |
| Fax |
|
| Email |
sonia.sunkesula@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology
government medical college
kadapa |
|
|
Primary Sponsor
|
| Name |
Dr Sunil Chiruvella |
| Address |
Department of anesthesiology
government medical college
kadapa
|
| Type of Sponsor |
Other [self] |
|
|
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 Sunkesula Sonia Begum |
Government General Hospital |
Department of anesthesiology
Cuddapah
ANDHRA PRADESH |
8897573489
sonia.sunkesula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government medical college,kadapa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA1 and ASA2
age between 18 to 80 years
patients posted for elective surgery under general anesthesia |
|
| ExclusionCriteria |
| Details |
Patients with upper airway pathology
Mouth opening less than 3.5cms
Cervical mass
Pregnancy
Uncooperative patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the lower jaw protrusion maneuver and neck extension with thyromental distance and modified mallampati test in correlation with cormack-lehene grading of difficulty in intubation during anesthesia |
0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE DEMOGRAPHIC CHARACTERISTICS LIKE AGE,SEX,HEIGHT & BMI FOR PREDICTING THE DIFFICULT INTUBATION |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2024 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A proper airway assessment plays a vital role in the prevention of airway related adverse events. Careful preoperative evaluation of the patients allows the anesthesiologist to plan alternative methods of securing the airway and experienced help. The aim of the study is to find out the best among the two sets of airway assessment predictions i.e. lower jaw protrusion maneuver with neck extension versus thyromental distance with modified mallampati test. A total of 70 patients of either sex undergoing tracheal intubation posted for elective surgeries under general anesthesia are included. All these measurements are correlated with modified cormack-lehene grading of difficulty in intubation during anesthesia. The study ended once the cormack-lehene grade is assessed. The data used before induction and data obtained after laryngoscopy will be used as a method to assess each combination measurement and its relation to the difficulty of intubation. |