| CTRI Number |
CTRI/2023/12/060965 [Registered on: 29/12/2023] Trial Registered Prospectively |
| Last Modified On: |
18/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A comparitive study between two laryngoscope C- MAC D- Blade videolaryngoscope and McCoy laryngoscope on their effectiveness in airway management |
|
Scientific Title of Study
|
A comparison between C-MAC D-Blade videolaryngoscope and McCoy on ease of intubation and hemodynamics at laryngoscopy and intubation in patients with anticipated difficult airway |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Venugopal A |
| Designation |
Additional Professor |
| Affiliation |
Regional Cancer Centre, Thiruvananthapuram |
| Address |
Department of Anaesthesiology
regional Cancer centre
Thiruvananthapuram
Nandanam, Erappukuzhy
Kudappanakkunnu , Thiruvananthapuram , Kerala
695043
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447220032 |
| Fax |
04712447454 |
| Email |
venuanila@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venugopal A |
| Designation |
Additional Professor |
| Affiliation |
Regional Cancer Centre, Thiruvananthapuram |
| Address |
Department of Anaesthesiology
regional Cancer centre
Thiruvananthapuram
Nandanam, Erappukuzhy
Kudappanakkunnu , Thiruvananthapuram , Kerala
695043
KERALA
695011
India |
| Phone |
9447220032 |
| Fax |
04712447454 |
| Email |
venuanila@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna P H |
| Designation |
Junior Resident |
| Affiliation |
Regional Cancer Centre, Thiruvananthapuram |
| Address |
Department of Anaesthesiology
regional Cancer centre
Thiruvananthapuram
Kumaramangalam
Aralummoodu
Neyyattinkara P O
Thiruvananthapuram,Kerala
695123
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9539929252 |
| Fax |
|
| Email |
krrishna.ph@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Cancer Centre, Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Regional Cancer Centre |
| Address |
Regional Cancer Centre
Thiruvananthapuram |
| Type of Sponsor |
Other [state owned cancer care centre and research centre] |
|
|
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 Krishna P H |
Regional Cancer Centre |
Department of Anaesthesiology
Thiruvananthapuram
KERALA |
9539929252
krrishna.ph@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| human ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Modified Mallampati class 3 and 4 and thyromental distance less than 6 cm
2. ASA PS I and II
3. BMI between 18.5 and 24.9 |
|
| ExclusionCriteria |
| Details |
1. restricted neck mobility
2. limited mouth opening ( less than 3 cm)
3. hypertensive patients on beta blockers
4. major cardiovascular diseases
5. hyperthyroidism
6. pregnancy |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the time taken for sucessful intubation using C-MAC D_ Bladevideolaryngoscope and McCoy laryngoscope in patients with anticipated difficult airway |
at the time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to compare the changes in hemodynamic parameters ( heart rate and blood pressure)
need for any optimizing Maneuvres and number of intubatin attempts |
1, 3,5 and 10 minutes ( hemodynamic parameters)
optimizing maneuvres and number of attempts- at the time of intubation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
31/12/2023 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this ampispective observational study we aimed to compare C-MAC D- Blade videolaryngoscope and McCoy laryngoscope on ease of intubation in terms of laryngoscopic view and time taken for intubation in patients with anticipated difficult airway posted for elective surgical procedures. As secondary objective we would like to compare hemodynamic parameters like heart rate and blood pressure at the time of intubation and at 1,3,5, and 10 miutes following intubation. we also compare the need for any optimising maneuvres and number of laryngoscopy attempt between this two groups . Study setting is Department Of anaesthesiology , Regional Cancer centre < thiruvananthapuram. Sample size as calculated from the previous study is 70 with 35 in each group. however we will collect details of 80 patients to compensate for attrition . study period is 8 months. |