| CTRI Number |
CTRI/2025/01/079495 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
COMPARISON BETWEEN TWO DIFFERENT LARYNGOSCOPE BLADES WHILE USING THEM IN DIFFERENT PATIENTS IN GENERAL ANAESTHESIA |
|
Scientific Title of Study
|
Ease of intubation and hemodynamic responses to endotracheal intubation using Flexitip blade in comparison with traditional Macintosh laryngoscope |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NiL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR JULIE C R MISQUITH |
| Designation |
Associate Professor |
| Affiliation |
Kasturba medical college,Mangalore. |
| Address |
Kasturba Medical College,
Light House Hill Road,
Hampankatta,
Mangalore.
Kasturba Medical College,
Light House Hill Road,
Hampankatta,
Mangalore.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9945598911 |
| Fax |
|
| Email |
Julie.misquith@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GORREPATI NAVEEN REDDY |
| Designation |
Junior Resident |
| Affiliation |
Kasturba medical college,Mangalore. |
| Address |
Kasturba Medical College,Light House Hill Road,Hampankatta,Mangalore.
Kasturba Medical College,Light House Hill Road,Hampankatta,Mangalore.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
6301924797 |
| Fax |
|
| Email |
naveen1647reddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR JULIE C R MISQUITH |
| Designation |
Associate Professor |
| Affiliation |
Kasturba medical college,Mangalore. |
| Address |
Kasturba Medical College,Light House Hill Road,Hampankatta,Mangalore.
Kasturba Medical College,Light House Hill Road,Hampankatta,Mangalore.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9945598911 |
| Fax |
|
| Email |
Julie.misquith@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education,Dakshina Kannada,
Karnataka,576104. |
|
|
Primary Sponsor
|
| Name |
DR GORREPATI NAVEEN REDDY |
| Address |
Department of Anaesthesiology
Kasturba Medical College,
Light house hill road,
Hampankatta,
Mangalore-575001. |
| Type of Sponsor |
Other [ Other[self]] |
|
|
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 Julie CR Misquith |
Kasturba medical college ,mangalore. |
Department of Anaesthesiology
Kasturba Medical College,Light House Hill Road,Hampankatta,Mangalore.
Dakshina Kannada
KARNATAKA |
9945598911
julie.misquith@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Kasturba Medical College,Mangalore |
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 |
Macintosh blade |
Ease of intubation comparison between Tripti blade and Macintosh blade |
| Intervention |
Trupti blade |
Whether ease of intubation with Trupti blade is better when compared to Macintosh blade |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
BMI less than 30kg/m2 |
|
| ExclusionCriteria |
| Details |
Patients refusal to participate in the study.
Patients with history of difficult intubation.
Patients with history of diabetes mellitus,hypertension,bronchial asthma.
Patients with history of chronic obstructive airway disease.
Patients with history of ischemic heart disease.
Patients undergoing head and neck surgery.
BMI more than 30kg/m2 |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess ease of intubation |
0 min , 3 min, 5 min and 10 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of attempts
External manoeuvre
Hemodynamic response
Trauma
|
1 min
3min
5min
10min |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
To assess the ease of intubation and hemodynamic responses while performing endotracheal intubation using flexitip laryngoscope blade in comparison with traditional macintosh laryngoscope blade in general anaesthesia.
The study will compare two different laryngoscope blades for use in endotracheal intubation in general anaesthesia comparing which one is better with respect to technicality and patient stress response. |