| CTRI Number |
CTRI/2024/01/061207 [Registered on: 08/01/2024] Trial Registered Prospectively |
| Last Modified On: |
03/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between Macintosh laryngoscope and king vision vidio laryngoscope for intubation in oral cancer surgery patients. |
|
Scientific Title of Study
|
Randomized controlled study to compare the status of intubation and haemodynamic changes using Macintosh laryngoscope and King Vision video laryngoscope in patients requiring nasotracheal intubation undergoing oral cancer surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubham Badal Petkar |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaestheisa Jawaharlal Nehru Medical College Sawangi (Meghe) wardha
Department of Anaesthesia Jawaharlal Nehru Medical College Sawangi ( Meghe) Wardha
Maharashtra
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8788191874 |
| Fax |
|
| Email |
sbp.027@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVivek Chakole |
| Designation |
Head Of Department |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesia Jawaharlal Nehru Medical College Sawangi( Meghe) Wardha
Department of Anaesthesia Jawaharlal Nehru Medical College Sawangi( Meghe) Wardha
Maharashtra
442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
7583836564 |
| Fax |
|
| Email |
drvivekchakole@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubham Badal Petkar |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of anaesthesia ,jawaharlal Nehru Medical College , sawangi meghe, wardha
Department of Anaesthesia Jawaharlal Nehru Medical College Sawangi( Meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8788191874 |
| Fax |
|
| Email |
sbp.027@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital,Wardha |
|
|
Primary Sponsor
|
| Name |
JNMC SAWANGI |
| Address |
SAWANGI WARDHA |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Shubham petkar |
Acharya Vinoba Bhave Rural Hospital |
Department OF Anaesthesia ,Jawaharlal Nehru Medical College , Sawangi Meghe, Wardha.
Wardha
MAHARASHTRA |
8788191874
sbp.027@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Use of King vision video laryngoscope for nasotracheal intubation. |
Nasotracheal intubation to be done in oral cancer surgery patient with King vision video laryngoscope by senior anaesthesiologist.Maximum 3 attemps will be given for intubation and patients will be observe for 5 minutes for any haemodynamic changes. |
| Intervention |
Use of Normal macintosh laryngoscope. for Nasotracheal intubation in oral cancer surgery patients. |
Nasotracheal intubation to be done in oral cancer surgery patient by senior anaesthesiologist with Normal macintosh laryngoscope.Maximum 3 attemps will be given for intubation and patients will be observe for 5 minutes for any Haemodynamic changes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients more than 18 years of either gender |
|
| ExclusionCriteria |
| Details |
patients refusal
patients with nasal deformities or fracture |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compared to Macintosh , king vision vidio laryngoscope is expected to take lesser number of attemps & lesser duration insertion to secure the airway |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| lesser haemodynamic changes with king vision vidio laryngoscope as compared to macintosh laryngoscope |
2 years |
|
|
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)
|
16/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/01/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is to compare the status of intubation and haemodynamic changes between Macintosh Laryngoscope and King Vision Vidio laryngoscope for nasotracheal intubation in oral cancer surgery patients. |