| CTRI Number |
CTRI/2018/01/011283 [Registered on: 11/01/2018] Trial Registered Prospectively |
| Last Modified On: |
03/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the effectiveness of inhaler and nebulizer in children aged 5-14 years with acute attack of asthma. |
|
Scientific Title of Study
|
Comparison of effectiveness of Metered dose inhaler with spacer and Nebulizer in children aged 5-14 years with acute asthma: Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishabh Batra |
| Designation |
Junior Resident, Department of Pediatrics |
| Affiliation |
Pt. B.D.Sharma PGIMS, Rohtak |
| Address |
Department of Pediatrics,
Pt. B.D.Sharma PGIMS, Rohtak
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
7206504349 |
| Fax |
|
| Email |
mailtorish16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok Khanna |
| Designation |
Professor, Department of Pediatrics |
| Affiliation |
Pt. B.D.Sharma PGIMS, Rohtak |
| Address |
Department of Pediatrics,
Pt. B.D.Sharma PGIMS, Rohtak
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9416685096 |
| Fax |
|
| Email |
vj78@live.in |
|
Details of Contact Person
Public Query
|
| Name |
Rishabh Batra |
| Designation |
Junior Resident, Department of Pediatrics |
| Affiliation |
Pt. B.D.Sharma PGIMS, Rohtak |
| Address |
Department of Pediatrics,
Pt. B.D.Sharma PGIMS, Rohtak
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
7206504349 |
| Fax |
|
| Email |
mailtorish16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B.D. Sharma PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt BDSharma PGIMS |
| Address |
Pt. B.D.Sharma PGIMS
Rohtak, Haryana
124001 |
| Type of Sponsor |
Government 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 Rishabh Batra |
Department of Pediatrics |
Department of Pediatrics
Pt. B.D. Sharma PGIMS
Rohtak, Haryana
124001
Rohtak
HARYANA |
7206504349
mailtorish16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt. B.D. Sharma PGIMS/UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute Bronchial Asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metered dose inhaler with spacer |
Salbutamol containing metered dose inhaler with 250ml spacer delivering 100mcg per puff |
| Comparator Agent |
Nebulizer |
Oxygen driven nebulizer using Salutamol respirator solution 5mg per ml |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 5-14 years diagnosed with acute asthma |
|
| ExclusionCriteria |
| Details |
Non consenting child |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Need for hospital admission
Duration of stay in the emergency department |
Need for hospital admission
Duration of stay in the emergency department |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Respiratory Rate
Heart rate
Use of accessory muscles
Auscultatory findings
Peak Expiratory Flow Rate
Development of tremor
PaCO2 on Venous Blood Gas Analysis
|
0 minutes
20 minutes
40 minutes
60 minutes |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
05/02/2018 |
| 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="1"
Months="0"
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
|
An informed written consent from parents will be
taken. A randomized
controlled trial study design will be used. Subjects will be defined as
asthmatic children aged 5-14 years who present to paediatric emergency with
acute attack of asthma. With the help of computer generated randomization table
the subjects will be divided into two groups. A sample size of 75 in
each group is taken. Enrolment number will be given to
ensure identity. Demographic data will be collected including name, father’s
name, age, sex and address with phone number. Disease history will include the
duration, severity of symptoms based on frequency of day and night symptoms,
co-morbidities, family history and current treatment being received.Subjects in group 1 will receive Salbutamol with the help
of MDI and spacer (250ml) thrice at intervals of 20 minutes and subjects in
group 2 will receive Salbutamol by oxygen driven nebulizer thrice at 20 minutes
interval. The subjects will be repeatedly
assessed to ensure clinical improvement. However, examination to record the
parameters that will be used for the comparison of effectiveness by these two
devices will be conducted only four times during the observation period i.e.- ·
Before giving any therapy
-
·
At 20 minutes duration
- ·
At 40 minutes duration
- ·
At 60 minutes duration.
The following parameters will be used for comparison
by using suitable statistical tests-
- 1. Respiratory
rate
- 2. Heart
rate
- 3. Use
of accessory muscles
- 4. Auscultatory
findings
- 5. Peak
expiratory flow rate
- 6. Development
of tremor
- 7. PaCO2
on Venous Blood Gas Analysis
- 8. Need
for hospital admission
- 9. Duration
of stay in emergency department
|