| CTRI Number |
CTRI/2021/11/037836 [Registered on: 08/11/2021] Trial Registered Prospectively |
| Last Modified On: |
01/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The Comparison of i-view and king vision video laryngoscope device used to put endotracheal tube in windpipe (trachea) to give anesthesia for surgery. |
|
Scientific Title of Study
|
A Comparative evaluation of i-view video laryngoscope and King vision video laryngoscope as an intubation device in patients undergoing elective surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SYED ZAFER HASHMI |
| Designation |
Junior Resident |
| Affiliation |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE, JNMCH, AMU,ALIGARH |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE,
JNMCH, AMU,ALIGARH.
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE
JNMCH AMU ALIGARH UTTAR PRADESH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9720412012 |
| Fax |
|
| Email |
zaferhashmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SYED KAMRAN HABIB |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE, JNMCH, AMU,ALIGARH |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE,
JNMCH, AMU,ALIGARH.
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE
JNMCH AMU ALIGARH UTTAR PRADESH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897172780 |
| Fax |
|
| Email |
syedkamranhabib@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SYED ZAFER HASHMI |
| Designation |
Junior Resident |
| Affiliation |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE, JNMCH, AMU,ALIGARH |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE,
JNMCH, AMU,ALIGARH.
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE
JNMCH AMU ALIGARH UTTAR PRADESH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9720412012 |
| Fax |
|
| Email |
zaferhashmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE
JNMCH AMU ALIGARH UTTAR PRADESH INDIA |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesia and Critical Care JNMCH AMU Aligarh |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| 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 |
| SYED ZAFER HASHMI |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE JNMCH |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE
JNMCH AMU ALIGARH UTTAR PRADESH INDIA 202002
Aligarh
UTTAR PRADESH |
9720412012
zaferhashmi@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: X||New Technology, |
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Written and informed consent
2.ASA I &II patients of either sex
3.All Mallampatti grades
4. Age between 20-60 years
5.Weight between 45-70 kg
6.Patients planned for elective surgery |
|
| ExclusionCriteria |
| Details |
1.Previous history of multiple/failed intubation
2.Head and neck surgery
3.Valvular heart disease,CAD,uncontrolled hypertension
4.Presence of raised intracranial pressure, cervical spine injury.
5.Any pathology of the oral cavity that will obstruct the insertion of device
6.Mouth opening <2.5cm
7.Potentially full stomach patients (trauma, morbid obesity, pregnancy, history of regurgitation and heart burn) and at risk of oesophageal reflux (hiatus hernia). |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the laryngoscopy & intubation time in seconds using the two devices |
The hemodynamic response at 1,3,5,10 minutes were recorded |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.To grade the ease of tracheal intubation using these devices.
2.To compare the number of adjustment maneuvers required for successful intubation.
3.To compare the hemodynamic response i.e., heart rate and mean arterial B.P (MABP) after laryngoscopy and intubation |
Heart rate shall be recorded from pulse-oximeter& MABP is to be recorded using non-invasive blood pressure measuring instrument. Immediate pre-induction value shall be recorded & considered as Control/baseline value. Thereafter, HR & MABP is to be recorded immediately after laryngoscopy & intubation & 3, 5 & 10 min later.
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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
|
Phase 3 |
|
Date of First Enrollment (India)
|
26/11/2021 |
| 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 |
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Publication Details
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Title: The Comparison of i-view and king vision video based laryngoscope devices used to put endotracheal tube in windpipe (trachea) to give anesthesia for surgery. Introduction : Video laryngoscope has become widely accepted nowadays due to ease of handling, high success rate in patient with normal and difficult airway and a steep learning curves.our study aiims to compare the i-view video laryngoscope with king visin video laryngoscope in terms of intubation time, adjustment maneuvers and hemodynamic responses. Our study therefore aims to compare the i-view video laryngoscope with king vision video laryngoscope in terms of intubation time, ease of tracheal intubation, adjustment maneuvers and hemodynamic responses. |