CTRI

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CTRI Number

CTRI/2021/01/030673 [Registered on: 21/01/2021] Trial Registered Prospectively

Last Modified On:

13/01/2021

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

For patients undergoing operation we use two instruments.Both are attached with camera and we put the tube into the mouth by seeing the video and compare the advantage and disadvantage among both the instruments.

Scientific Title of Study

Randomized controlled trial comparing Mcgrath Mac video laryngoscope with 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	K Monica
Designation	Postgraduate Student
Affiliation	SKS Hospital and Postgraduate Medical Institute
Address	Room no. 151, First Floor, Department of Anaesthesiology and Critical care, Sks Hospital and Postgraduate Medical Institute, Sks Hospital Road Salem. Room no 151,First Floor, Department of Anaesthesiology and Critical care SKS Hospital and Postgraduate Medical Institue, SKS Hospital Road, Salem. Salem TAMIL NADU 636004 India
Phone	9003767711
Fax
Email	kmonicacpt@gmail.com

Details of Contact Person
Scientific Query

Name	G Prabu
Designation	Consultant Anaesthesiology
Affiliation	Sks Hospital and Postgradute Medical Institution
Address	Room no. 151,First Floor, Department of Anaesthesiology and Critical care Sks Hospital and Postgraduate Medical Institute, Sks Hospital Road, Salem. Room no. 151,First Floor, Department of Anaesthesiology and Critical care Sks Hospital and Postgraduate Medical Institute, Sks Hospital Road, Salem. Salem TAMIL NADU 636004 India
Phone	9884469456
Fax
Email	gprabu_mmc@yahoo.co.in

Details of Contact Person
Public Query

Name	G Prabu
Designation	Consultant Anaesthesiology
Affiliation	Sks Hospital and Postgradute Medical Institution
Address	Room no. 151,First Floor, Department of Anaesthesiology and Critical Care Sks Hospital and Postgraduate Medical Institute, Sks Hospital Road, Salem. Room no. 151,First Floor, Department of Anaesthesiology and Critical Care, Sks Hospital and Postgraduate Medical Institute Sks Hospital Road, Salem. Salem TAMIL NADU 636004 India
Phone	9884469456
Fax
Email	gprabu_mmc@yahoo.co.in

Source of Monetary or Material Support

Suresh vishwanathan Managing Director,Room no 1 Ground floor, SKS hospital and postgraduate Institue, sks hospital road, salem.

Primary Sponsor

Name	k monica
Address	Room no.151 first floor,Department of Anesthesiology and critical care. sks hospital and postgraduate Institute, SKS hospital road, salem.
Type of Sponsor	Other [SELF]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
K Monica	SKS Hospital and Postgraduate Medical Insitiute	Room no 151,First Floor,Department of Anesthesiology and Critical Care.Sks Hospital and Postgraduate Medical Institute SKS Hospital Road, Salem-636004 Salem TAMIL NADU	9003767711 kmonicacpt@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee - SKS Hospital	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Intervention	KING VISION video laryngoscope	To access the ease of intubation and haemodynamic changes during intubation
Comparator Agent	MC GRATH video laryngoscope	To access the ease of intubation and haemodynamic changes during intubation

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1. Mallampati score 1 to 3 2. Patients under ASA 1 and 2 3. Elective surgeries

ExclusionCriteria

Details

1. Extremes of age(less than 18 and more than 70)
2. Patients on beta blockers
3. Emergency surgeries

Method of Generating Random Sequence

Permuted block randomization, variable

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
To access the ease and effecetives of intubation among MC GRATH and KING VISION video laryngoscope	within one minute

Secondary Outcome

Outcome	TimePoints
To access the duration and haemodynamic changes during intubation	Hemodynamic changes after 1 minute of 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 4

Date of First Enrollment (India)

30/01/2021

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="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Not yet published

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

A randomised controlled trail - McGrath Mac and king vision video laryngoscopes in ease of intubation,duration and haemodynamic changes to intubation are compared inpatients undergoing surgery under general anaesthesia with primary outcome being number of attempts and secondary outcomes being hemodynamic changes to intubation.