| CTRI Number |
CTRI/2022/09/045815 [Registered on: 23/09/2022] Trial Registered Prospectively |
| Last Modified On: |
18/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision between two intubating devices, vLarynx video laryngoscope and King Vision video laryngoscope, in adult patients undergoing surgery |
|
Scientific Title of Study
|
A prospective randomized study to compare vLarynx video laryngoscope and King Vision video laryngoscope in adult patients undergoing surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakeena Mohammadi Hashmi |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical College and hospital, AMU, Aligarh |
| Address |
Department of anaesthesiology and critical care, JNMCH, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8755206897 |
| Fax |
|
| Email |
sakeena.hashmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SYED HUSSAIN AMIR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Jawaharlal Nehru Medical College and hospital, AMU, Aligarh |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, JNMCH, AMU, ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897559183 |
| Fax |
|
| Email |
hussainamir77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SYED HUSSAIN AMIR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Jawaharlal Nehru Medical College and hospital, AMU, Aligarh |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, JNMCH, AMU, ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897559183 |
| Fax |
|
| Email |
hussainamir77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology and critical care, JNMCH, AMU, Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology and critical care JNMCH AMU Aligarh |
| Address |
Department of anaesthesiology and critical care, JNMCH, AMU, Aligarh |
| Type of Sponsor |
Government medical college |
|
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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 |
| Sakeena Mohammadi Hashmi |
Jawaharlal Nehru medical college and hospital , AMU |
OT complex, Department of anaesthesiology and critical care
Aligarh
UTTAR PRADESH |
8755206897
sakeena.hashmi@gmail.com |
|
|
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: K802||Calculus of gallbladder without cholecystitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group KV (King vision video laryngoscope) |
Group KV will be intubated using King vision video laryngoscope undergoing general anaesthesia. |
| Intervention |
Group VL (vLarynx video laryngoscope) |
Group VL will be intubated using vLarynx video laryngoscope undergoing general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of ASA grade I and II.
2. Weight between 41-70kg.
3. Patients planned for elective surgical procedures.
4. All grades of Mallampatti classification. |
|
| ExclusionCriteria |
| Details |
1.Previous history of multiple failed intubation.
2. Head and neck surgery.
3. Valvular heart disease.
4. CAD/uncontrolled hypertension.
5. Presence of raised intracranial pressure.
6. Cervical spine injury.
7. Predicted difficult laryngoscopy.
8. Any pathology of oral cavity that will obstruct the insertion of device.
9. Mouth opening <2.5cm.
10. Potentially full stomach patients (trauma, morbid obesity, pregnancy, history of gastric regurgitation and heart burn) and at risk of esophageal 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 |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the laryngoscopy and intubation time using the two devices. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare number of attempts for successful intubation.
2. To compare the glottic view using POGO (percentage of glottic opening) score.
3. To grade the ease of tracheal intubation using these devices.
4. To compare the hemodynamic response i.e., Heart Rate and Mean Arterial Blood Pressure after laryngoscopy and intubation.
5. To look for post operative complications if any. |
Pre intubation and at 1min, 3min and 5mins after intubation. |
|
|
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 2 |
|
Date of First Enrollment (India)
|
29/09/2022 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Abstract A prospective randomized study to compare vLarynx video laryngoscope and King Vision video laryngoscope in adult patients undergoing surgery
Sakeena Mohammadi Hashmi ***, Syed Hussain Amir **, Qazi Ehsaan Ali* Department of Anaesthesiology and Critical care, JNMCH, AMU, Aligarh
***Presenting author, **Supervisor, *Co-Supervisor
INTRODUCTION
During general anaesthesia difficulty in tracheal intubation and management of complicated airways remains one of the most important and demanding tasks. The traditional approach and agreed practice for tracheal intubation has been direct laryngoscopy using blade adjustment with Macintosh blade in adults. It requires skill and alignment of oropharyngo-laryngeal axis which is not always possible and thus poses a difficulty.
Visualization of vocal cords with instruments via an optical system or through a video systemia an alternative to direct laryngoscopy. Compared with it, video laryngoscopes have been described as being able to minimise difficulty, failure, trauma, and other complications.
The aim of this study is to compare the efficiency of vLarynx video laryngoscope with King Vision video laryngoscope as control while intubating patients.
MATERIAL AND METHODS
The study will include 60 patients undergoing elective general surgery under general anaesthesia requiring endotracheal intubation. Each group will include 30 patients.
Primary objective: To compare the laryngoscopy and intubation time using the two devices Secondary objectives: To compare number of attempts for successful intubation, compare the glottic view using POGO (percentage of glottic opening) score, grade the ease of tracheal intubation using these devices, compare the hemodynamic response i.e., Heart Rate and Mean Arterial Blood Pressure after laryngoscopy and intubation and to look for post operative complications if any.
RESULTS
Above quoted parameters will be recorded for both the devices and compared in this study.
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