| CTRI Number |
CTRI/2020/05/025471 [Registered on: 29/05/2020] Trial Registered Prospectively |
| Last Modified On: |
20/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Endotracheal Intubation by laryngoscope] |
| Study Design |
Other |
|
Public Title of Study
|
Comparison Of Efficiency Of Two Different Types Of Laryngoscopes During Endotracheal Intubation In Patient Undergoing General Anaesthesia |
|
Scientific Title of Study
|
Comparison Of Efficiency Of King Vision and airTraq video Laryngoscope During Endotracheal Intubation in patient undergoing General Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Urmila Palaria |
| Designation |
Professor |
| Affiliation |
Government Medical College, haldwani |
| Address |
department of anaesthesiology government medical college haldwani
Type 4/02 Government medical College campus rampur road haldwani
Nainital
UTTARANCHAL
263139
India |
| Phone |
9897088443 |
| Fax |
|
| Email |
urmila_palaria@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Urmila Palaria |
| Designation |
Professor |
| Affiliation |
Government Medical College, haldwani |
| Address |
department of anaesthesiology government medical college haldwani
Type IV/ 02, Government Medical College Campus, Rampur
Road, Haldwani, Nainital, Uttarakhand
Details Contact
Address
Nainital
Person
UTTARANCHAL
Public Query
263139
India
Nainital
UTTARANCHAL
263139
India |
| Phone |
9897088443 |
| Fax |
|
| Email |
urmila_palaria@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Monika Khati |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, haldwani |
| Address |
department of anaesthesiology Government medical College Haldwani
Room number G2 PG Girls Hostel GMC haldwani
Nainital
UTTARANCHAL
263139
India |
| Phone |
9627167965 |
| Fax |
|
| Email |
monika.manie@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and DR. Susheela Tiwari Hospital, Haldwani |
|
|
Primary Sponsor
|
| Name |
DR Monika Khati |
| Address |
Room no. G2 PG GIRLS HOSTEL government medical College haldwani |
| Type of Sponsor |
Other [self funded study] |
|
|
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 |
| DR Monika Khati |
GOVERNMENT MEDICAL COLLEGE AND ASSOCIATED DR SUSHEELA TIWARI GOVERNMENT HOSPITAL |
Department Of Anaesthesiology Critical Care and Pain and Palliative Medicine, RAMPUR ROAD, HALDWANI
Nainital
UTTARANCHAL |
9627167965
monika.manie@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE, GOVERNMENT MEDICAL COLLEGE, HALDWANI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, (2) ICD-10 Condition: R00-R09||Symptoms and signs involving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endotracheal intubation |
Intubation by video laryngoscopes |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
ASA1 and ASA2
MPS grade 1 and 2
BMI less than 30kg/M2
Elective surgery under general anaesthesia requiring endotracheal Intubation.
Surgery lasting for 1-2 hour. |
|
| ExclusionCriteria |
| Details |
Patient refusal.
ASA 3 and ASA 4.
MPS grade 3 and 4.
Laryngoscope lasted for more than 30sec.
Requirement of change of Laryngoscope.
Pregnant patient.
BMI more than 30kg/M2.
Age less than 20years and more than 40years. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare best visibility of glottis.
To compare time required for Laryngoscopy.
To compare time required for single attempt endotracheal Intubation.
To compare no. Of requirement of using McIntosh laryngoscope in case of failure in endotracheal Intubation with said device.
To compare associated complications, if any. |
At baseline or 30 seconds of baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare haemodynamic changes during endotracheal Intubation by said device. |
At Baseline, at every 2 minutes, after extubation, and every 6hours upto 24hours of extubation. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare the efficiency of King Vision and airTraq video Laryngoscope During endotracheal Intubation in patients undergoing General anaesthesia. |