| CTRI Number |
CTRI/2022/10/046863 [Registered on: 28/10/2022] Trial Registered Prospectively |
| Last Modified On: |
27/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Other (Specify) |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of intubation performance between channeled & non channeled blades of videolaryngoscope in obese patients with BMI more than 30 |
|
Scientific Title of Study
|
Comparison of non channeled v/s channeled videolaryngoscope for orotracheal intubation in obese patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivani Yadav |
| Designation |
PG3 |
| Affiliation |
Dr SN Medical college jodhpur |
| Address |
Main OT complex, Department of anaesthesia .MDM Hospital , Dr SN Medical college jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9529397327 |
| Fax |
|
| Email |
shivaniyadav9501@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr F S Bhati |
| Designation |
Professor |
| Affiliation |
Dr SN Medical college jodhpur |
| Address |
Main OT Complex,
Mahatma Gandhi Hospital
Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9529397327 |
| Fax |
|
| Email |
fatehbhati68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Yadav |
| Designation |
PG3 |
| Affiliation |
Dr SN Medical college jodhpur |
| Address |
MDM Hospital main OT Complex
Department of Anaesthesia
Dr SN Medical college jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9529397327 |
| Fax |
|
| Email |
shivaniyadav9501@gmail.com |
|
|
Source of Monetary or Material Support
|
| MDM Hospital, Dr SN Medical college , Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Shivani Yadav |
| Address |
MDM hospital, Dr SN Medical College Jodhpur |
| 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 Shivani Yadav |
Mathura Das Mathur Hospital |
Main OT Complex, Department of anaesthesia ,
Jodhpur
RAJASTHAN |
9529397327
shivaniyadav9501@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hira Lal |
38/M C/O- C5-C6 PIVD, Laminectomy done under General anaesthesia using non channeled videolaryngoscope |
| Intervention |
Smita Garg |
36/F,C/O Cholelithiasis. Laproscopic cholecystectomy done under General anaesthesia using channeled videolaryngoscope |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgeries with BMI more than 30 & age more than 18 years. |
|
| ExclusionCriteria |
| Details |
Patients refusal & those having potential risk of regurgitation are excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time required for intubation in channeled & non channeled blades of videolaryngoscope. |
Just after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Success rate
Time of intubation
No of attempts |
30 min |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/10/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparison of intubation performance between channeled & non channeled blades of videolaryngoscope in patients with BMI more than 30kg/m2. By comparing the time required & ease of intubation we can lessen the intubation period in obese patients with difficult intubation. |