| CTRI Number |
CTRI/2021/01/030476 [Registered on: 14/01/2021] Trial Registered Prospectively |
| Last Modified On: |
07/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
COMPARISON OF DEVICES(SCREEN VIDEO LARYNGOSCOPE AND MACINTOSH) FOR PASSING TUBE IN AIRWAY AND ITS EFFECTS. |
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Scientific Title of Study
|
A PROSPECTIVE RANDOMIZED STUDY TO COMPARE AND EVALUATE THE HAEMODYNAMIC DERANGEMENTS USING SCREEN VIDEO LARYNGOSCOPE AND MACINTOSH LARYNGOSCOPE AS INTUBATING DEVICES IN ADULT PATIENTS.
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| Trial Acronym |
|
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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 |
MOHD AMIR HASAN KHAN |
| Designation |
SENIOR RESIDENT |
| Affiliation |
JNMC |
| Address |
DEPARTMENT OF ANAESTHESIA JNMC AMU ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8218682532 |
| Fax |
|
| Email |
aamirhsnkhn@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
QAZI EHSAN ALI |
| Designation |
PROFESSOR |
| Affiliation |
JNMC |
| Address |
DEPARTMENT OF ANAESTHESIA JNMC AMU ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417701769 |
| Fax |
|
| Email |
qaziehsanali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
QAZI EHSAN ALI |
| Designation |
PROFESSOR |
| Affiliation |
JNMC |
| Address |
DEPARTMENT OF ANAESTHESIA JNMC AMU ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417701769 |
| Fax |
|
| Email |
qaziehsanali@gmail.com |
|
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Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College And Hospital |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF ANAESTHESIA |
| Address |
DEPARTMENT OF ANAESTHESIA JNMC AMU ALIGARH |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| MOHD AMIR HASAN KHAN |
Jawaharlal Nehru Medical College and Hospital |
Department of Anaesthesiology and Critical care
Aligarh
UTTAR PRADESH |
8218682532
aamirhsnkhn@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
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: R688||Other general symptoms and signs, UNDERGOING ELECTIVE SURGERY, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MACINTOSH LARYNGOSCOPE |
COMPARISON OF HAEMODYNAMIC DERANGEMENT THRICE A WEEK FOR 6 MONTHS |
| Comparator Agent |
SCREEN VIDEO LARYNGOSCOPE |
COMPARISON OF HAEMODYNAMIC DERANGEMENTS TWICE A WEEK FOR 6 MONTHS |
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I & II patients.
Age between 20-60 years
Weight between 40-70 kg
Patients with either sex
Patients planned for elective surgery
|
|
| ExclusionCriteria |
| Details |
Patients with previous history of multiple/ failed intubation.
Patients with predicted difficult laryngoscopy except for all class of MP Grades
Patients with any pathology of the oral cavity that may obstruct the insertion of device
Mouth opening less than 2.5cm.
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 |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| 1. To compare the haemodynamic changes i.e. difference in Mean arterial blood pressure(MABP) and Heart rate using Screenvideo laryngoscope and Macintosh laryngoscope as an intubating aid. |
Immediately after intubation,1 minute, 3 minute and 5 minute after intubation |
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Secondary Outcome
|
| Outcome |
TimePoints |
1. Success rate of intubation
2. Time taken for intubation
3. Maneuvers needed for successful intubation
4. Ease of intubation
5. Number of attempts taken for intubation
6. Complications if any
|
2 YEARS |
|
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
31/01/2021 |
| 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="2"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
NOT YET |
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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 And evaluate haemodynamic derangements using
screen video laryngoscope and macintosh laryngoscope as Intubating device in Adults Patients.
Mohd Amir hasan khan***,Qazi Ehsan Ali**,Syed Hussain Amir*
Department of Anaesthesiology and Critical Care
JNMCH AMU Aligarh
***Presenting Author,**Professor,*Assistant Professor
INTRODUCTION
Life saving measures in any emergency situation is described
under the acronym “ABCD†where “A†stands for airway.(1) So, airway
management is a primary consideration in any clinical situation including
cardiopulmonary resuscitation, anaesthesia, emergency medicine, intensive care
and first aid etc.
Direct
laryngoscopy and passage of endotracheal tube through the larynx is a noxious
stimulus, which can provoke untoward response in the cardiovascular,
respiratory and other physiological systems(4).Significant
tachycardia and hypertension can occur with tracheal intubation under light
anaesthesia.
The magnitude of cardiovascular response is directly related
to the force and duration of laryngoscopy.
The purpose of the study is to compare the haemodynamic
changes using screen video laryngoscope and Macintosh laryngoscope for
intubation in elective adult surgical patients.
MATERIAL
AND METHODS
Elective Endotracheal
Intubation had been carried out by using SVL and Mac in 40 patients each.
Hemodynamic parameters were
noted down at pre-induction, 1 min, 3 min and 5 min post intubation period.
RESULT
Study is still in progress
around 20 cases of both the groups have been taken up .
Current trends are showing more
haemodynamic derangements in patients intubated with macintosh in comparison to
SVC.
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