| CTRI Number |
CTRI/2020/07/026627 [Registered on: 16/07/2020] Trial Registered Prospectively |
| Last Modified On: |
15/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
predicting the accuracy of the preanaestgetic check up tests in predicting difficult intubation |
|
Scientific Title of Study
|
Diagnostic accuracy of tests done for predicting difficult intubation during preanaesthetic check up visit among patients undergoing cardiac surgery under general anaesthesia,SMS Medical College,Jaipur |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr REEMA MEENA |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
SMS Medical college Jiapur |
| Address |
Department of Anaesthesiology
SMS medical college
Jiapur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413237117 |
| Fax |
|
| Email |
reemadrrn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr REEMA MEENA |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
SMS Medical college Jiapur |
| Address |
Department of Anaesthesiology
SMS medical college
Jiapur
RAJASTHAN
302004
India |
| Phone |
9413237117 |
| Fax |
|
| Email |
reemadrrn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHWETHA V |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical college |
| Address |
Department of anaesthesia
SMS medical college
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9571388268 |
| Fax |
|
| Email |
shwethav93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, sms medical college, jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology SMS medical college |
| Address |
Department of Anaesthesiology
SMS medical college JLN marg Jaipur pin code 302004 |
| 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 REEMA MEENA |
SMS medical college |
Department of Anaesthesiology 2nd floor Dhanvantri bhavan
Jaipur
RAJASTHAN |
9413237117
reemadrrn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS medical college Ethics comittee Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA grade 1 and 2
Patients scheduled for surgery under general anaesthesia and requiring endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
Ptients with upper airway pathology, neck mass and cervical spine injury |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the accuracy of diagnostic tests done for predicting difficult intubation during pre anaesthetic checkup visit |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate the percentage of actual difficult intubation |
8 months |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
21/07/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study we determine the accuracy of each diagnostic tests done in predicting difficult intubation. And also we will estimate the percentage of actual difficult intubation. |