| CTRI Number |
CTRI/2021/07/034513 [Registered on: 01/07/2021] Trial Registered Prospectively |
| Last Modified On: |
30/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Is tracheal intubation with Macintosh and McCoy laryngoscopes comparable in terms of hemodynamics? |
|
Scientific Title of Study
|
Comparison of hemodynamic response during tracheal intubation using Macintosh and McCoy laryngoscopes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hisana Valliyath |
| Designation |
Student |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesia and Operation Theatre Technology
Justice K S Hegde Charitable Hospital
Deralakatte
Mangaluru
NITTE Nursing Hostel
Paneer Campus
Deralakatte
Mangaluru
575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8281515338 |
| Fax |
|
| Email |
hisanavalliyath338@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hisana Valliyath |
| Designation |
Student |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesia and Operation Theatre Technology
Justice K S Hegde Charitable Hospital
Deralakatte
Mangaluru
NITTE Nursing Hostel
Paneer Campus
Deralakatte
Mangaluru
575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8281515338 |
| Fax |
|
| Email |
hisanavalliyath338@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hisana Valliyath |
| Designation |
Student |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesia and Operation Theatre Technology
Justice K S Hegde Charitable Hospital
Deralakatte
Mangaluru
NITTE Nursing Hostel
Paneer Campus
Deralakatte
Mangaluru
575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8281515338 |
| Fax |
|
| Email |
hisanavalliyath338@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy |
| Address |
Justice K S Hegde Hospital
Deralakatte
Mangaluru |
| 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 |
| Dr Sumalatha R Shetty |
Justice K S Hegde charitable hospital |
Department of Anaesthesia and Operation theatre technology,
K S Hegde Medical Academy,
Deralakatte,
Mangaluru,
Pin: 575018
Dakshina Kannada
KARNATAKA |
9448115617
sumarshetty@nitte.edu.in |
|
|
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 |
| Intervention |
Intubation with Macintosh and McCoy laryngoscopes
|
Patients will be intubated with either Macintosh or McCoy laryngoscope by the consultant
anaesthesiologist. The investigator will observe the hemodynamic parameters at different time intervals upto 10 min post intubation.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1- Patient aged between 20-50 years
2- Patient with ASA physical status of I& II
3- Patients undergoing endotracheal intubation with McCoy or Macintosh laryngoscope. |
|
| ExclusionCriteria |
| Details |
Patients with:
1-Intubation requiring more than one attempt
2-Time for intubation longer than 30 seconds
3-Pregnant patients
4-Those cases where standard induction protocol of the institution is not used
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find the hemodynamic changes during laryngoscopy and intubation using Macintosh and McCoy laryngoscopes in terms of
ï¬Heart rate
ï¬Systolic Blood pressure
ï¬Diastolic blood pressure
ï¬Mean blood pressure
ï¬Arrhythmias if any
|
Baseline, before laryngoscopy, immediately after intubation, 1,2,3,5,10th minute after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for intubation |
After intubation |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
01/07/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is conducted to compare the hemodynamic response during tracheal intubation using Macintosh and McCoy laryngoscope blades in patients undergoing general anaesthesia.
|