Comparison of the effect of salbutamol nebulizer alone against salbutamol nebulizer and palmicorte in the treatment of patients with bronchospasm after rainfall to the emergency room of imam khomeini in autumn 2020
Determine the effect of salbutamol nebulizer alone againts salbutamol nebulizer and palmicorte in the treatment of patients with bronchospasm after rainfall to the emergency room of imam khomeini in ahvaz in autumn 2020
This study was conducted in Imam Khomeini hospital in Ahvaz as a randomized clinical trial and a 2-group, randomly assigned to one or two envelopes randomly selected.
Participants/Inclusion and exclusion criteria
Inclusion: aged at least 18 years and up to 55 years old. Exclusion: pregnancy; smoking more than 10 packs per day and sever asthma.
Intervention groups
Comparsion of the efficacy of palmicorte and salbutamol concomitantly with the efficacy of salbutamol only on bronchospasm fallowing rainfall.
Main outcome variables
Shortness of breath; increased respiratory rate; decreased arterial oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200109046061N1
Registration date:2020-01-19, 1398/10/29
Registration timing:prospective
Last update:2020-01-19, 1398/10/29
Update count:0
Registration date
2020-01-19, 1398/10/29
Registrant information
Name
Elnaz Nobakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8617 5194
Email address
dr.elnaznobakht@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of salbutamol nebulizer alone against salbutamol nebulizer and palmicorte in the treatment of patients with bronchospasm after rainfall to the emergency room of imam khomeini in autumn 2020
Public title
Effect of palmicorte in the trearment of patients with broncospasm after rainfall
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Must be at least 18 years old and up to 55 years old
Bronchospasm and shortness of breath following rainfall
Exclusion criteria:
Failure to respond to treatment and worsen clinical condition of patients with intravenous magnesium sulfate/epineghrine or intubation(severe asthma)
Pregnant women
Smoker patients consuming more than 10 packs per year
Beta-agonist nebulizer treatment over the past 6 hours
Patients refusal to cooperate during treatment process
Underlying pulmonary disease with asthma-like manifestations such as ILD and...
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
228
Randomization (investigator's opinion)
Randomized
Randomization description
Accidentalize individuals in 40 groups of up to 6 by giving sealed envelopes to 20 other groups form number one envelopes and number envelops to 20 other groups that we do not know which type in each envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants in the project and the researcher were kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Scienses
Street address
Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-12-28, 1398/10/07
Ethics committee reference number
IR.AJUMS.REC.1398.684
Health conditions studied
1
Description of health condition studied
Bronchospasm and shortness of breath after the first autumn rains
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Peak expiratory flow
Timepoint
Before the intervention, 20 mintues after the intervention, 40 minutes later and 60 minutes later
Method of measurement
By using a flow meter pic
2
Description
Forced expiratory volume
Timepoint
Before the intervention, 20 mintues after the intervention, 40 minutes later and 60 minutes later
Method of measurement
By using a flow meter pic
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: salbutamol nebulizer 0.5 mg for 20 minutes 3 times in 60 minutes
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: salbutamol and palmicort nebulizer 0.5 mg for 20 minutes 3 times in 60 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Dr. Ali Vefagh Nematollahi
Street address
Imam khomeini Specialized Training Center, Azadegan Ave., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Fax
+98 61 3222 5763
Email
dr.elnaznobakht@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6155855619
Phone
+98 61 3338 7712
Email
dr.elnaznobakht@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Ali Vefagh Nematollahi
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam khomeini Specialized Training Center, Azadegan Ave., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3338 7712
Email
dr.elnaznobakht@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Ali Vefagh Nematollahi
Position
associante professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam khomeini Specialized Training Center, Azadegan Ave., Ahvaz
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Patient information including dyspnea and bronchospasm. How to use the drugs and their effects on patients who are enrolled in the questionnaire and ultimately analyzed. Patient-informed in the study and the names of participants are shared. Do not share with us for patient privacy.
When the data will become available and for how long
The start of the access period after the end of the job is the result of the confimation
To whom data/document is available
It will be accessible to everyone
Under which criteria data/document could be used
Use salbutamol and palmicort or bronchospasm after rainfall to access this study.
From where data/document is obtainable
Email your requests to alivefagh@yahoo.com
What processes are involved for a request to access data/document