Protocol summary

Study aim
Assessment and comparison of two standard protocols for management of asthma attack in patients admitted to Imam Khomeini and Golestan Hospitals emergency rooms in Ahwaz, Iran
Design
This study include 66 patients divided in two intervention and control groups; each group with 33 patient. It is a double blind study. Patients are coded in bases of table of random number, then are divided to two groups. Analyzer coding patients in basis of table of random numbers. Patients, research fellow and evaluator of events kept to be blind. This study is a phase 3 type clinical trial.
Settings and conduct
This is study will be done at Golestan and Imam Khomeini hospital of ahvaz.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with clinical and para clinical approved asthma with clinical presentation of acute asthma attack and minimum age 18 years old and maximum 65 years old. Exclusion criteria: COPD, CHF, pnumonia, lung disease, nursing mothers, pregnancy, fever, administration of salbutamol in the last 6 hours.
Intervention groups
Intervention group: the intervention group were recorded at 0, 20, 40, 60 spirometric values of FEV1 and PEFR were measured and recorded. For each patient to record the values of FEV1 and PEFR, 3 times a spirometry performed and is considered the highest number. Immediately after spirometry, nebulize salbutamol dose (2.5 mg), as well as magnesium sulfate 2.5 CC Of 20 g / 100CC done. The control group were recorded at 0, 20, 40, 60 spirometric values of FEV1 and PEFR were measured and recorded. For each patient to record the values of FEV1 and PEFR, 3 times a spirometry performed and is considered the highest number. Immediately after spirometry, nebulize salbutamol 2 / 5CC (2.5 mg), with 1.5 CC of saline in the control group will receive.
Main outcome variables
Clinical state; forced expiratory volume in first second; peak expiratory flow rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151103024853N3
Registration date: 2018-07-15, 1397/04/24
Registration timing: registered_while_recruiting

Last update: 2018-07-15, 1397/04/24
Update count: 0
Registration date
2018-07-15, 1397/04/24
Registrant information
Name
Leila Kouti
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8379
Email address
kouti-l@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment and comparison of two standard protocols for management of asthma attack in patients admitted to Imam Khomeini and Golestan Hospitals emergency rooms in Ahwaz, Iran
Public title
Assessment and comparison of two standard protocols for management of asthma attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with clinical and para clinical approved asthma with clinical presentation of acute asthma attack Age: minimum 18 years old and maximum 65 years old
Exclusion criteria:
COPD CHF Pneumonia Lung disease Nursing mothers Fever Pregnancy Administration of salbutamol in the last 6 hours
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients to be coding in bases of table of random number, then divide to two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, research fellow and evaluator of events 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 Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2017-12-05, 1396/09/14
Ethics committee reference number
IR.AJUMSA.REC.1396.817

Health conditions studied

1

Description of health condition studied
Acute asthma attack
ICD-10 code
J45.901
ICD-10 code description
Unspecified asthma with (acute) exacerbation

Primary outcomes

1

Description
Clinical state
Timepoint
Before intervention, 20, 40, 60 minutes after intervention
Method of measurement
Base on alert status, talking, wizing, use of respiratory muscles

2

Description
Forced Expiratory Volum in First Secend (FEV1)
Timepoint
Before intervention, 20, 40, 60 minutes after intervention
Method of measurement
Mililiter with use of Peak Flow Meter

3

Description
Peak Expiratory Flow Rate(PEFR)
Timepoint
Before intervention, 20, 40, 60 minutes after intervention
Method of measurement
Mililiter with use of Peak Flow Meter

Secondary outcomes

1

Description
Blood pressure
Timepoint
Before intervention, 20, 40, 60 minutes after intervention
Method of measurement
mm Hg

2

Description
Pulse Rate
Timepoint
Before intervention, 20, 40, 60 minutes after intervention
Method of measurement
Rate/Minutes

3

Description
Respiratory Rate
Timepoint
Before intervention, 20, 40, 60 minutes after intervention
Method of measurement
Rate/Minutes

4

Description
Saturation of arterial blood oxygen (SO2 %)
Timepoint
Before intervention, 20, 40, 60 minutes after intervention
Method of measurement
Pulse Oximetry

Intervention groups

1

Description
Intervention group: the intervention group were recorded at 0, 20, 40, 60 spirometric values of FEV1 and PEFR were measured and recorded. For each patient to record the values of FEV1 and PEFR, 3 times a spirometry performed and is considered the highest number. Immediately after spirometry, nebulize salbutamol dose (2.5 mg), as well as magnesium sulfate 2.5 CC Of 20 g / 100CC done.
Category
Treatment - Drugs

2

Description
Control group: the control group were recorded at 0, 20, 40, 60 spirometric values of FEV1 and PEFR were measured and recorded. For each patient to record the values of FEV1 and PEFR, 3 times a spirometry performed and is considered the highest number. Immediately after spirometry, nebulize salbutamol 2 / 5CC (2.5 mg), with 1.5 CC of saline in the control group will receive.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
DR. leila kouti
Street address
golestan,Ahvaz Golestan Hospital
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
lkouti.pharmacotherapy@gmail.com

2

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr . Leila Kouti
Street address
Imam Khomeini Hospital , 24 metri street, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 2818
Email
lkouti.pharmacotherapy@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
Ground floor, Deputy of research and technology developement, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
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. Leila Kouti
Position
board certified clinical pharmacist / Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz Faculty of Pharmacy, Golestan street, Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8380
Email
lkouti.pharmacotherapy@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Leila Kouti
Position
Board certified clinical pharmacist / Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz Faculty of Pharmacy, Golestan street, Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8380
Email
lkouti.pharmacotherapy@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Leila Kouti
Position
Board certified clinical pharmacist / Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz Faculty of Pharmacy, Golestan street, Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8380
Email
lkouti.pharmacotherapy@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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