| CTRI Number |
CTRI/2025/09/094283 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Teaching in mannequin regarding mask ventilation and performing in real patients] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of mannequin vs video based technique for teaching mask ventilation for medical students |
|
Scientific Title of Study
|
EFFECTIVENESS OF VIDEO BASED VS. MANNEQUIN BASED TRAINING FOR MASK VENTILATION AMONG MEDICAL STUDENTS - A COMPARATIVE CROSS-SECTIONAL STUDY |
| 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 Sneha Joseph |
| Designation |
PG RESIDENT |
| Affiliation |
Jubilee mission medical college |
| Address |
Fathima Nagar, Mahatma nagar , Nellikunnu
Jubilee mission medical college, Fathima Nagar, Thrissur
Thrissur
KERALA
680006
India |
| Phone |
9656205324 |
| Fax |
|
| Email |
snehaannjoseph237@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vigil Peter |
| Designation |
Associate Professor |
| Affiliation |
Jubilee mission medical college |
| Address |
Fathima Nagar, Mahatma nagar , Nellikunnu
Thrissur
KERALA
680006
India |
| Phone |
80781 61981 |
| Fax |
|
| Email |
drpeteralapatt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneha Joseph |
| Designation |
PG RESIDENT |
| Affiliation |
Jubilee mission medical college |
| Address |
Fathima Nagar, Mahatma nagar , Nellikunnu
Thrissur
KERALA
680006
India |
| Phone |
9656205324 |
| Fax |
|
| Email |
snehaannjoseph237@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia jubilee mission medical college |
| Address |
Jubilee mission medical college, Fathima Nagar Nellikunu, Thrissur |
| 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 Sneha Joseph |
Jubilee mission medical college |
Kolbe Ot complex, OT A1 - A14, Department of Anaesthesia
Thrissur
KERALA |
9656205324
snehaannjoseph237@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Jubilee mission medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MBBS undergraduate healthy students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mask ventilation in mannequin and via video based |
Mask ventilation is taught among medical students as 2 groups, one with mannequin and the other via video based and effectiveness of mask ventilation assessed in real time patients in both the groups |
| Comparator Agent |
Mask ventilation in real time patients among the 2 groups |
Both the groups of students : mannequin as well as video based group are assessed for effective mask ventilation and we compare which group has a better effective mask ventilation among the 2 groups |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
All students posted in the department of anaesthesia in Jubilee mission medical college |
|
| ExclusionCriteria |
| Details |
1)those with formal training in airway management
2) candidate refusal
3)Those with disability making it difficult for them to hold the mask
4)patients more than 80 years
5)Edentulous patients
6) patients with NG tube, facial burns , more than 35 BMI patients, beard and patients with multiple facial fractures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of mask ventilation as assessed by proper ventilation (chest rise , EtCo2, Spo2 value) in the 2 groups of medical students trained by mannequin and video based technique |
Assessed in 30 seconds interval starting from 0 second to 90 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Candidate satisfaction score |
Based on questionnaire |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
04/10/2025 |
| 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)
|
Open to Recruitment |
| 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
|
mask ventilation plays a pivotal role in managing emergency airway situations Maintenance of airway patency and oxygenation are its main objectives Effectiveness of mask ventilation can be found using real time monitoring which is assessed by measuring parameters such as capnogram, etco2 values and expiratory tidal volume. In our study we aim to compare the effectiveness of video based and mannequin based sessions for imparting training for mask ventilation among fourth year medical students.
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