| CTRI Number |
CTRI/2022/05/042821 [Registered on: 26/05/2022] Trial Registered Prospectively |
| Last Modified On: |
26/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of different devices to secure airway for intubation in manikin with difficult airway by experienced doctors |
|
Scientific Title of Study
|
COMPARISON OF DIFFERENT VIDEO LARYNGOSCOPES FOR NASOTRACHEAL INTUBATION IN MANIKIN WITH DIFFICULT AIRWAY BY EXPERIENCED ANAESTHESIOLOGIST: A RANDOMISED, SELF CONTROLLED, CROSSOVER TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prateek Maurya |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
ROOM 139,
DR. BRAIRCH
AIIMS, NEW DELHI
ROOM 139,
DR. BRAIRCH
AIIMS, NEW DELHI
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
zprateekmaurya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishkarsh Gupta |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
ROOM 139,
DR. BRAIRCH
AIIMS, NEW DELHI
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drnishkarsh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishkarsh Gupta |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
ROOM 139,
DR. BRAIRCH
AIIMS, NEW DELHI
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drnishkarsh@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ONCOANAESTHESIA AND PALLIATIVE MEDICINE |
|
|
Primary Sponsor
|
| Name |
AIIMS HOSPITAL |
| Address |
DR BRAIRCH,AIIMS,NEW DELHI |
| Type of Sponsor |
Research institution and hospital |
|
|
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 PRATEEK MAURYA |
AIIMS |
STUDIO NO 2, 2ND FLOOR,SET FACILITY,AIIMS, NEW DELHI
South
DELHI |
8287772555
ZPRATEEKMAURYA@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POSTGRADUATE RESEARCH, AIIMS , NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY DOCTORS WILL PERFORM INTUBATION ON MANIKIN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
C- MAC |
VIDOE LARYNGOSCOPE |
| Comparator Agent |
DIRECT LARYNGOSCOPE |
MACINTOSH DIRECT LARYNGOSCOPE BLADE 3 |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ANAESTHESIOLOGIST HAVING 3 YEARS OF EXPERIENCE |
|
| ExclusionCriteria |
| Details |
ANAESTHESIOLOGIST WITH LESS THAN 3 YEARS OF EXPERIENCE |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare three different kind of laryngoscopes (Macintosh, Cmac, Kings vision) with respect to intubation characteristics in nasotracheal intubation on manikin |
At baseline (just after intubation attempt) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare time of intubation in normal and difficult airway with three different kind of laryngoscope |
At baseline (just after intubation attempt) |
| To compare force applied during intubation in both normal and difficult airway with three different kind of laryngoscopes. |
At baseline (just after intubation attempt) |
| To assess failed intubation in normal and difficult airway with three different kind of laryngoscopes. |
At baseline (just after intubation attempt) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
27/05/2022 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
IN THIS STUDY WE WILL BE RECRUITING ANAESTHESIOLOGIST WITH 3 YEARS OF EXPERIENCE, THEY WILL BE DOING A NASOTRACHEAL INTUBATION ON MANIKIN WITH DIFFERENT LARYNGOSCOPES. WE WILL BE RECORDING DIFFERENT INTUBATION PARAMETERS |