| CTRI Number |
CTRI/2025/05/086351 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy of flexible video endoscope versus video laryngoscope for oral endotracheal intubation in left lateral position under general anaesthesia. |
|
Scientific Title of Study
|
A prospective randomized study to compare the efficacy of flexible video endoscope versus video laryngoscope for oral endotracheal intubation in left lateral position under general anaesthesia in department of anaesthesia S.M.S 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 Mamta Sharma |
| Designation |
Senior Professor |
| Affiliation |
Sms medical college and hospital |
| Address |
Ent Ot
Charak Bhawan Gate No 6
Dept Of Anaesthesia sawai man singh medical college jaipur
Sms hospital, jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829566077 |
| Fax |
|
| Email |
drmamtasharma@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohit Kumar Goyal |
| Designation |
Junior Resident |
| Affiliation |
SMS medical college and Hospital Jaipur |
| Address |
Department Of anaesthesia
sms medical college & hospital jaipur
Sms medical college and hospital
jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9667855970 |
| Fax |
|
| Email |
mgoyal941@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Kumar Goyal |
| Designation |
Junior Resident |
| Affiliation |
SMS medical college and Hospital Jaipur |
| Address |
Department Of Anaesthesia
sms medical college & hospital jaipur
Sms medical college & hospital
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9667855970 |
| Fax |
|
| Email |
mgoyal941@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia
Sms medical college and hospital
Jaipur Rajasthan
India
pincode 302004 |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia sawai man singh medical college jaipur |
| Address |
Department of anaesthesia sawai man singh medical college jaipur Rajasthan 302004 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MOHIT KUMAR GOYAL |
SMS MEDICAL COLLEGE AND HOSPITAL |
Department of aneasthesia
Sms medical college and hospital
Jaipur
RAJASTHAN |
9667855970
mgoyal941@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sms medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Flexible video endoscope and video laryngoscope
|
We will intubate the patient in left lateral position with the help of flexible video endoscope and video laryngoscope after we will compare primary and secondary objectives.
|
| Intervention |
Intubation in left lateral position
|
We will intubate the patient in left lateral position.
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex undergoing surgery requiring oral endotracheal intubation under general anaesthesia.
2.Patients willing to give consent.
3.Age group of 20 - 55 years .
4.ASA grade 1 , 2
|
|
| ExclusionCriteria |
| Details |
Upper respiratory tract infection.
Anticipated difficult intubation according to standard intubation criteria.
Pharyngolaryngeal disorder.
Cervical spine abnormality.
Increase risk of aspiration (full stomach)
pregnant patient |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OUTCOME:
To assess and compare difference in intubation time(in seconds) between two groups.
To assess and compare success rate of first and second attempt .
To assess and compare the intubation failure rate.
|
at baseline, 1 minute, 3 minute,
5 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome-
To assess & compare ease of intubation between two groups (Grade 10 , 1- very poor ,10- Excellent).
To assess & compare difference in hemodynamic parameters (HR,SBP,DBP,MAP) between two groups.
To assess & compare intubation dependent complications-Oral mucosal injury, Dental injury, Hypoxemia spo2 92%
|
at baseline , 1 minute , 3 minute , 5 minute |
|
|
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)
|
20/05/2025 |
| 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="2" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
my primary purpose is mention below · To assess and compare difference in intubation time(in seconds) between two groups. · To assess and compare success rate of first and second attempt . To assess and compare the intubation failure rate. |