| CTRI Number |
CTRI/2020/07/026779 [Registered on: 24/07/2020] Trial Registered Prospectively |
| Last Modified On: |
06/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
training and education |
| Study Design |
Other |
|
Public Title of Study
|
A comparison of a box and plastic sheet for ease of anaesthesia management on a child dummy. |
|
Scientific Title of Study
|
A prospective study comparing ease of intubation through an intubation box and a transparent plastic sheet in the paediatric airway manikin |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gita Nath |
| Designation |
Consultant |
| Affiliation |
Rainbow Children Hospital |
| Address |
4th floor OT Complex
Rainbow Children Hospital
Road no 2
Banjara Hills
Hyderabad
TELANGANA
500034
India |
| Phone |
09000241012 |
| Fax |
|
| Email |
drgitanath@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Sailaja |
| Designation |
Consultant |
| Affiliation |
RainbowChildren Hospital |
| Address |
4th floor OT complex
Rainbow Children Hospital
Road no 2
Banjara Hills
Hyderabad
TELANGANA
500032
India |
| Phone |
07093322303 |
| Fax |
|
| Email |
sailu_k_78@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Sailaja |
| Designation |
Consultant |
| Affiliation |
RainbowChildren Hospital |
| Address |
4th floor OT Complex
Rainbow Children Hospital
Road no 2
Banjara Hills
Hyderabad
TELANGANA
500032
India |
| Phone |
07093322303 |
| Fax |
|
| Email |
sailu_k_78@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Rainbow Children Hospital
Road No 2, Banjara Hills, Hyderabad, Telangana, India |
|
|
Primary Sponsor
|
| Name |
Dr Gita Nath |
| Address |
4th floor OT complex
Rainbow children hospital
Road no 2
Banjara Hills
Hyderabad |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 Gita Nath |
Rainbow Children Hospital |
4th floor
OT Complex
Road no 2
Banjara Hills
Hyderabad
Hyderabad
TELANGANA |
9000241012
drgitanath@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rainbow Children Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Doctors with more than 5 years’ experience in intubation
Maximum 3 attempts at intubation
|
|
| ExclusionCriteria |
| Details |
Doctors with any acute illness will not be included in the study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the time taken for intubation without a barrier device, with an Intubation Box and with a transparent Plastic Sheet.
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Number of attempts at intubation (maximum 3 attempts)
2)Cormack Lehane Grading
3)POGO scoring
4)Ease of intubation Grading
5)Removal of visor for ease of intubation will be noted if done by the participant
|
baseline |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="19" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/07/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is an academic study on a paediatric manikin for comparing the efficiency of intubation box versus plastic sheet for safe intubation. Participants are doctors wearing face shields, experienced in intubation for more than 5 years, who will intubate the paediatric manikin without barrier, with intubation box and with a clear plastic sheet in a randomized order with blinding to each other’s performance. Time taken to successful intubation, number of attempts, different scorings for view of larynx and ease of intubation will be used to assess the performance. Statistical analysis will be done to decide which is a better barrier device among the two,i.e., the intubation box and the clear plastic sheet. This will help us in guiding the future usage of barrier devices in the present situation. |