| CTRI Number |
CTRI/2024/02/062230 [Registered on: 02/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two video assisted devices for intubation in patients with simulated cervical fracture injury |
|
Scientific Title of Study
|
A COMPARATIVE STUDY BETWEEN VIDEO LARYNGOSCOPE AND VIDEO STYLET FOR TRACHEAL INTUBATION IN PATIENTS WITH SIMULATED CERVICAL FRACTURE INJURY - A PROSPECTIVE RANDOMISED CONTROLLED STUDY. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajin Sanu |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9514675589 |
| Fax |
|
| Email |
ajinsanu.513@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syed Moied Ahmed |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897454739 |
| Fax |
|
| Email |
syedmoiedahmed123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajin Sanu |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9514675589 |
| Fax |
|
| Email |
ajinsanu.513@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Aligarh Muslim University |
|
|
Primary Sponsor
|
| Name |
Ajin Sanu |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Ajin Sanu |
Jawaharlal Nehru Medical College |
Department of Anaesthesiology and Critical Care
Aligarh
UTTAR PRADESH |
9514675589
ajinsanu.513@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Regd.), Jawaharlal Nehru Medical college and Hospital, Faculty of Medicine, Aligarh Muslim University, Aligarh U.P. India - 202002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intubation using video laryngoscope |
Intubating routine surgery patients using video laryngoscope in simulated cervical fracture injury |
| Intervention |
Intubation using video stylet |
Intubating routine surgery patients using video stylet in simulated cervical fracture injury |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA Grade I & II patients
2)Age between 20-70 years
3)Weight between 40-70 kg
4)Patients of both sexes
5)All classes of MP Grades |
|
| ExclusionCriteria |
| Details |
1. Anticipated difficult airway with restricted head and neck movements and TMD less than 6 cm
2.Patients with hemodynamic and respiratory compromise
3. Mouth opening less than 2.5 cm
4. Potentially full stomach patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
First attempt successful intubation
|
Time from insertion of device between incisors and appearance of end tidal carbondioxide in monitor in the first attempt |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1)Comparison of time for successful intubation
(2)To compare changes in heart rate, mean arterial blood pressure, oxygen saturation during intubation using these two devices. |
number of attempts
To measure changes in heart rate, mean arterial blood pressure & oxygen saturation(pre induction, post intubation & after 3 minutes & 5 minutes) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/02/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•In severely injured patients, the cervical spine must be protected by in-line immobilisation during airway management. However, manual in-line stabilisation can make alignment of the oral, pharyngeal and laryngeal axes difficult, resulting in a poor direct laryngoscopic view and prolonging the intubation time . There are a lot of studies and literatures showing the usefulness of C Mac video laryngoscope in intubating patients with cervical fracture .The Flexible fiberoptic bronchoscopes, could be better alternative to video laryngoscope ,but it requires expertise, not portable and cannot manage complication of bleedingVideo stylet is portable and easier to use than a flexible bronchoscope . Therefore the aim of this study will be to compare the first attempt success rate as a primary outcome, between CMAC VL and Karl Storz Video Stylet in patients with simulated cervical fracture.
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