Determining the effect of salbutamol administration by inhalation together with rapid and deep breathing without coordination in the treatment of acute obstructive pulmonary diseases. 1) Determination and comparison of mean PEF 5 minutes after starting treatment in the intervention and standard treatment groups; 2) Determination and comparison of mean PEF 10 minutes after starting treatment in the intervention and standard treatment groups; 3) Determination and comparison of mean PEF 15 minutes after starting treatment in the intervention and standard treatment groups.
Design
Clinical trial
Settings and conduct
Patients 15–75 years of age who visit the emergency department of Shahid Sadoughi Hospital in Yazd, Iran, due to bronchospasm caused by inhalation, asthma, or COPD. The patient is asked to breathe rapidly and deeply during medication inhalation. Three puffs are given in rapid succession with 1-second intervals. After 10-15 minutes, three more puffs are given in the same way. A peak flow meter is used to assess the patient’s response to the inhalation method at 0, 5, 10, and 15 minutes after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients 15–75 years of age who visit the emergency department of Shahid Sadoughi Hospital in Yazd, Iran, due to bronchospasm caused by inhalation, asthma, or COPD. Lack of severe respiratory distress and absence of other underlying diseases that require treatments other than inhaled salbutamol. Exclusion criteria: 1) Patients who need treatments other than salbutamol, such as atrovent, combivent, or pulmicort; 2) Patients who visit the emergency department with signs of respiratory failure, including acrocyanosis, PO2 below 60 mmHg, or PCO2 above 80 mmHg
Intervention groups
Patients who visited Shahid Sadoughi Hospital and needed salbutamol inhaler therapy
Main outcome variables
peak expiratory flow
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171231038154N1
Registration date:2018-08-17, 1397/05/26
Registration timing:registered_while_recruiting
Last update:2018-08-17, 1397/05/26
Update count:0
Registration date
2018-08-17, 1397/05/26
Registrant information
Name
Ebrahim Akbarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3278 2686
Email address
dr.akbarzadeh@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2018-09-01, 1397/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of salbutamol administration by inhalation together with rapid and deep breathing in comparison with the standard method: A clinical trial
Public title
The effect of salbutamol administration by inhalation together with rapid and deep breathing in comparison with the standard method: A clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 15–75 years of age who visit the emergency department of Shahid Sadoughi Hospital in Yazd, Iran, due to bronchospasm caused by inhalation, asthma, or COPD. Lack of severe respiratory distress and absence of other underlying diseases that require treatments other than inhaled salbutamol.
Exclusion criteria:
Patients who need treatments other than salbutamol, such as atrovent, combivent, or pulmicort;
Patients who visit the emergency department with signs of respiratory failure, including acrocyanosis, PO2 below 60 mmHg, or PCO2 above 80 mmHg
Age
From 15 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants were made aware that there were two different methods of salbutamol administration. However, they did not know to which group they belonged. Data analysis was performed using coded data and the analyzer had no knowledge of the particular group for each code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University Campus, School of Medicine, Prof. Hesabi Blvd.
City
Yazd
Province
Yazd
Postal code
891513149
Approval date
2016-10-19, 1395/07/28
Ethics committee reference number
IR.SSU.MEDICINE.REC.1395.181
Health conditions studied
1
Description of health condition studied
DYSPNEA
ICD-10 code
J39.3
ICD-10 code description
Upper respiratory tract hypersensitivity reaction, site unspecified
Primary outcomes
1
Description
peak expiratory flow
Timepoint
0, 5min, 10min, 15min
Method of measurement
peak flow meter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patient is asked to breathe rapidly and deeply during medication inhalation. Three puffs are given in rapid succession with 1-second intervals. After 10-15 minutes, three more puffs are given in the same way. A peak flow meter is used to assess the patient’s response to the inhalation method at 0, 5, 10, and 15 minutes after treatment.
Category
Treatment - Devices
2
Description
Control group: In this group, the patients are treated according to the standard method for salbutamol inhaler administration: The inhaler is placed near the patient’s mouth or between the patient’s teeth. The patient is instructed to inhale slowly simultaneous with inhaler administration, hold his/her breath for ten seconds, and then exhale. Six inhaler puffs are given, and a peak flow meter is used to assess the patients' response to the inhalation method at 0, 5, 10, and 15 minutes after treatment.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital, Yazd, Iran
Full name of responsible person
Ebrahim Akbarzadeh
Street address
Shahid Sadoughi Hospital, Shahid Ghandi Blvd.
City
Yazd
Province
Yazd
Postal code
891513149
Phone
+98 35 3820 3410
Email
dr.akbarzadeh@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Vice-President for Research, Yazd University of Medical Sciences
Street address
Shahid Sadoughi University Campus, School of Medicine, Prof. Hesabi Blvd.
City
ٰYazd
Province
Yazd
Postal code
891513149
Phone
+98 35 3820 3410
Email
dr.akbarzadeh@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Ebrahim Akbarzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
School of Medicine, Prof. Hesabi Blvd.
City
Yazd
Province
Yazd
Postal code
891513149
Phone
+98 35 3820 3410
Email
dr.akbarzadeh@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ebrahim Akbarzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
School of Medicine, Prof. Hesabi Blvd.
City
Yazd
Province
Yazd
Postal code
891513149
Phone
+98 35 3820 3410
Email
dr.akbarzadeh@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ebrahim Akbarzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
School of Medicine, Prof. Hesabi Blvd.
City
Yazd
Province
Yazd
Postal code
891513149
Phone
+98 35 3820 3410
Email
dr.akbarzadeh@bums.ac.ir
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