| CTRI Number |
CTRI/2021/09/036440 [Registered on: 13/09/2021] Trial Registered Prospectively |
| Last Modified On: |
10/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Changes in blood pressures and heart rate during General Anaesthesia intubation using 3 different laryngoscopes |
|
Scientific Title of Study
|
Hemodynamic response to laryngoscopy and endotracheal intubation using C Mac, King vision and Mac Intosh laryngoscope-A prospective randomized comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TPriyadarshini |
| Designation |
Postgraduate |
| Affiliation |
Sri ramachandra medical college |
| Address |
Sri Ramachandra Institute of Higher Education and Research Porur
Chennai
Sri ramchandra Institute of higher education and research
Chennai
TAMIL NADU
600116
India |
| Phone |
9444640222 |
| Fax |
|
| Email |
Priya.thiagu24895@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akilandeshwari |
| Designation |
Professor |
| Affiliation |
Sri ramachandra medical college |
| Address |
Sri Ramachandra Institute of Higher Education and Research Porur
Chennai
Sri ramachandra Institute of higher education and research
Chennai
TAMIL NADU
600116
India |
| Phone |
9840636238 |
| Fax |
|
| Email |
makilandeswari@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
TPriyadarshini |
| Designation |
Postgraduate |
| Affiliation |
Sri ramachandra medical college |
| Address |
Sri Ramachandra Institute of Higher Education and Research Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9444640222 |
| Fax |
|
| Email |
Priya.thiagu24895@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri ramachandra institute of higher education and research |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research Porur |
| Type of Sponsor |
Research institution |
|
|
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 |
| DRPRIYADARSHINI |
Sri ramachandra institute of higher education and research |
Department of anaesthesiology
Sri ramachandra institute of higher education and research
PORUR
CHENNAI
Chennai
TAMIL NADU |
9444640222
priya.thiagu24895@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R625||Other and unspecified lack of expected normal physiological development in childhood, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
C MAC and kING VISION Laryngoscoeps |
My study is to see the hemodynamic response while intervening with standard mac intOsh laryngoscope when compared to videolayngoscopes C MAC and KING VISION |
| Intervention |
Laryngoscopy amd endotracheal intubation |
To see for the Hemodynamic response while intervening with different types of Laryngoscopes during enditracheal jntubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All age groups and both genders |
|
| ExclusionCriteria |
| Details |
1.Difficult airway
2.hypertensives
3.pregnancy
4.laryngeal lesions |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the hemodynamic response (systolic and diastolic blood pressure, heart rate,mean arterial pressure)to laryngoscopy and endotracheal intubation with C-MAC, KING VISION AND MAC INTOSH LARYNGOSCOPE |
Baseline,postinduction,Pre intubation, post extubaton,every 3 mins for 10 m8ns after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="141"
Sample Size from India="141"
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)
|
16/09/2021 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
To study is done to find out the best laryngoscope which decreases the hemodynamic response to laryngoscopy and endotracheal intubation Possible benefits 1.Decrease in cardiovascular stress response 2.Less hemodynamic stimulation 3.Decrease in incidence of sore throat 4.improved glottic view |