| CTRI Number |
CTRI/2018/12/016504 [Registered on: 03/12/2018] Trial Registered Retrospectively |
| Last Modified On: |
01/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
junior resident will predict the difficulty in airway during pre anaesthetic examination and same will be confirmed by the experienced anaesthesiologist during endotracheal tube insertion in operation theatre |
|
Scientific Title of Study
|
An Evaluation Of Impact Of Anaesthesiologists Experiance On Prediction Of Difficult Airway |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Kumar |
| Designation |
Resident |
| Affiliation |
RNT Medical College and Attached Hospital |
| Address |
Department of Anaesthesiology
RNT Medical College,Udaipur
Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
7568256234 |
| Fax |
07568256234 |
| Email |
drsandeepkumarchoudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Bedi |
| Designation |
Associate Professor |
| Affiliation |
RNT Medical College and Attached Hospital |
| Address |
Department of Anaesthesiology
RNT Medical College, Udaipur
Rajasthan
Udaipur
RAJASTHAN
313011
India |
| Phone |
9829025373 |
| Fax |
|
| Email |
drvikrambedi@rediff.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Kumar |
| Designation |
Resident |
| Affiliation |
RNT Medical College and Attached Hospital |
| Address |
Department of Anaesthesiology
RNT Medical College,Udaipur
Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
7568256234 |
| Fax |
07568256234 |
| Email |
drsandeepkumarchoudhary@gmail.com |
|
|
Source of Monetary or Material Support
|
| RNT medical college and attached hospital,udaipur ,rajasthan
313001 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| sandeep kumar |
RNT MEDICAL COLLEGE AND ATTACHED HOSPITAL |
Department of Anaesthesiology
PAE room no 16 MB hospital
Udaipur
RAJASTHAN |
7568256234
7568256234
drsandeepkumarchoudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
all ASA 1 to 4 grade patients coming for pre anaesthetic evaluation in hospital, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All ASA grade I to IV patients more than 18 years age presenting to the pre-anaesthetic examination at MB Hospital RNT Medical College Udaipur and scheduled to undergo surgery under General Endotracheal Anaesthesia (GETA) shall be included in the study
|
|
| ExclusionCriteria |
| Details |
patients below 18 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| predictive value of pre operative assessment of difficult airway |
six month period |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "700"
Final Enrollment numbers achieved (India)="700" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2017 |
| Date of Study Completion (India) |
01/09/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Anticipation of a difficult airway remains one of the core premises of anaesthesiology since the inception of the speciality.The present study is proposed to evaluate the impact of anaesthesiologist’s experience on predicting a difficult airway, when using established methods of pre-operative evaluation of the airway.After approval of the institutional ethical committee, the present study will be conducted at M.B. Hospital, attached to RNT Medical College, Udaipur (Raj) over a period of 6 months.The study has been designed as a prospective, double blind, randomized observational study. The study shall be carried out for a period of six months.All ASA grade I to IV patients more than 18 years age presenting to the pre-anaesthetic examination at M.B Hospital R.N.T Medical College Udaipur and scheduled to undergo surgery under General Endotracheal Anaesthesia (GETA) shall be included in the study. Prior to enrolment written and informed consent will be taken. These patients shall be randomly divided into two groups using a computer generated table of random numbers in opaque sealed envelope. GROUP 1-Airway assessment will be done by resident anaesthesiologist (with at least 2 years of experience) GROUP 2- Airway assessment will be done by a consultant anaesthesiologist (> 5 years of experience The primary outcome measure will be to evaluate differences in positive predictive value of difficult airway as assessed in the two groups. The said assessment will be done by using Mallampati scoring system and LEMON scoring system. |