Evaluation of the effect of clinical and peak expiratory flow rate of nebulization of Albuterol and Heliox (helium 70%,oxygen 20%) versus nebulization of Albuterol and Oxygen during acute asthma exacerbation
Goal: Evaluation of the effect of clinical and peak expiratory flow rate of nebulization of Albuterol and Heliox (helium 70%,oxygen 20%) versus nebulization of Albuterol and Oxygen during acute asthma exacerbation. Trial Study will be done on 96 patients in intervention and control groups, we'll give Heliox in addition to standard treatment to the intervention group and so the control group will receive standard treatment.
Inclusion Criteria: Acute Asthma Attack with minimum of 18 years old and maximum of 55year; Exclusion Criteria: History of Smoking more than 10 pack/ years; History of chronic bronchitis; acute medical problem; History of Cardiovascular Diseases; cardiac arythmia; Pregnant women; treatment with nebulization of beta agonist during 6 hours ago. results of FEV1,PEFR and clinical states will be analyzed between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100715446N6
Registration date:2015-11-06, 1394/08/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-06, 1394/08/15
Registrant information
Name
Hassan Motamed
Name of organization / entity
Emegency Department , Ahvaz Jundishapour University of Medical Sciences , Ahvaz , Iran
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3079
Email address
motamed-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of clinical and peak expiratory flow rate of nebulization of Albuterol and Heliox (helium 70%,oxygen 20%) versus nebulization of Albuterol and Oxygen during acute asthma exacerbation
Public title
Evaluation of heliox efficacy in acute asthma attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Acute Asthma Attack with minimum of 18 years old and maximum of 55year;
Exclusion Criteria: History of Smoking more than 10 pack/ years; History of chronic bronchitis; acute medical problem; History of Cardiovascular Diseases;cardiac arythmia; Pregnant women; treatment with nebulization of beta agonist during 6 hours ago.
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Research Assistant, Next to central Building, Ahvaz Jundishapur University of Medical Sciences, University town
City
Ahvaz
Postal code
61357-15794
Approval date
2015-08-25, 1394/06/03
Ethics committee reference number
IR.AJUMS.REC.1394.303
Health conditions studied
1
Description of health condition studied
Acute attack asthma
ICD-10 code
J45
ICD-10 code description
Asthma
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 Second (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
with Pulse Oximetry
5
Description
Pulsus Paradox
Timepoint
Before intervention 20,40,60 minutes after intervention
Method of measurement
10 reduse of Blood Pressure during inspiration
Intervention groups
1
Description
Intervention Group: Salbutamol 2.5mg each 20 minutes via nebulizer Atrovent 2.5mg each 20 minutes 3 times during 60 minutes via oral Prednisolone 50mg one time.Heliox accompanying Albuterol 10 mil/lit nebulized each 20 minutes 3 times during 60 minutes.in all of patients measure and record Clinical State,FEV1,PEFR before intervention and 20,40,60 minutes after intervention.BP,PR,RR,PP,SO2% measure and record too.
Category
Treatment - Drugs
2
Description
Control Group: Salbutamol 2.5mg each 20 minutes with nebulizer Atrovent 2.5mg each 20 minutes 3 times during 60 minutes with oral Prednisolone 50mg one time.Clinical State,FEV1,PEFR measure and record before intervention and 20,40,60 minutes intervention.BP,RR,PR,PP,S02% measure and record too.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Dr. Hasan Motamed
Street address
Ahvaz, golestan street, Ahvaz Golestan Hospital
City
Ahvaz
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Hasan Motamed
Street address
Imam Khomeini Hospital , 24 metri street, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chanceller for research,Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Research Assistant,Next to center Building, Ahvaz Jundishapur University of Medical Sciences, University town
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chanceller for research,Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Golestan Hospital
Full name of responsible person
Dr. Hasan Motamed
Position
Emergency Medicine Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital,Golestan street,Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3079
Fax
Email
Hasan_motamed@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Golestan Hospital
Full name of responsible person
Dr. Hasan Motamed
Position
Emergency Medicine Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital,Golestan street,Ahvaz
City
Ahvaz
Postal code
613573318
Phone
+98 61 3374 3079
Fax
Email
Hasan_motamed@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Golestan Hospital
Full name of responsible person
Dr. Hasan Motamed
Position
Emergency Medicine Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital,Golestan street,Ahvaz
City
Ahvaz
Postal code
613573318
Phone
+98 61 3374 3079
Fax
Email
Hasan_motamed@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)