| CTRI Number |
CTRI/2018/01/011318 [Registered on: 15/01/2018] Trial Registered Prospectively |
| Last Modified On: |
15/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing 3 ways of how to hold the mask on face of a child while giving anesthesia |
|
Scientific Title of Study
|
Comparison of three Mask holding techniques for ventilating children less than 2 years- A randomized crossover study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Jain |
| Designation |
Additional professor |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
Department of anesthesia and intensive care
sector 12
PGIMER
Chandigarh
Department of anesthesia and intensive care
sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
jaindivya77@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Jain |
| Designation |
Additional professor |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
Department of anesthesia and intensive care
sector 12
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
jaindivya77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Jain |
| Designation |
Additional professor |
| Affiliation |
Postgraduate institute of medical education and research |
| Address |
Department of anesthesia and intensive care
sector 12
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
jaindivya77@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate institute of medical education and research.
Sector 12
Chandigarh |
|
|
Primary Sponsor
|
| Name |
Postgraduate institute of medical education and research |
| Address |
Department of anesthesia and intensive care
Postgraduate institute of medical education and research
Sector 12
Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Divya Jain |
Postgraduate institute of medical education and research |
Department of anaesthesia
PGIMER
Sector 12
Chandigarh
Chandigarh
CHANDIGARH |
7087008020
jaindivya77@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Children less than 2 years undergoing surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1- Single hand CE
|
Mask ventilation is done holding mask with single hand CE technique. |
| Intervention |
Group 2- Both hand CE technique |
Mask ventilation is done holding mask with both hand CE technique. |
| Intervention |
Group 3- Both hand modified VE clamp technique. |
Mask ventilation by holding mask with modified VE clamp technique. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
Children less than 2 years
undergoing surgery
|
|
| ExclusionCriteria |
| Details |
Children with syndromic facies
ASA 3 AND 4
Children undergoing rapid sequence induction |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expired tidal volume |
Following 5 consecutive breaths after each technique of ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of failed ventilation.
2. Leak fraction |
At the end of 5 breaths of mask ventilation with the study technique.
2. At the end of 5 breaths of mask ventilation with the study technique. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/01/2018 |
| 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)?
|
|
Brief Summary
|
3 techniques of mask ventilation namely- single hand CE, both hand CE and both hand modified VE clamp technique would be used in children less than 2 years. |