Comparison of hospitalization time with deoulin nebulizer, deoulin nebulizer with inhalation spray and deoulin nebulizer and pulmicort simultaneously in patients with chronic obstructive pulmonary disease in the disease exacerbation stage
Comparison of hospitalization time with deoulin nebulizer, deoulin nebulizer with inhalation spray and deoulin nebulizer and pulmicort simultaneously in patients with COPD
Design
This is a parallel randomized controlled clinical trial that will be performed on 174 patients with chronic obstructive pulmonary disease. Randomization in this research is done using quadri blocks using syntax written in SPSS program.
Settings and conduct
This study will conduct as a clinical trial study with 174 patients who will refer to Imam Hossain Hospital of Shahroud.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18 to 80 years; patients with confirmed diagnosis of chronic obstructive pulmonary disease by spirometric and clinical findings and conscious consent to participate in research.
Exclusion criteria:Loss of consciousness; severe respiratory distress with oxygen pressure less than 60 mm Hg and carbon dioxide pressure greater than 45 mm Hg in a venous gas sample; existence of severe infectious diseases of the respiratory tract for at least one month.
Intervention groups
For the first intervention group, deoulin nebulization in a 2.5 ml vial every 20 minutes once to three times with salbutamol and atrovent sprays 8 puffs and repeat both sprays up to three times every 20 minutes with the use of asmyar will be prescribed . For the second intervention group, deoulin nebulization (salbutamol + ipratropium bromide) in a 2.5 ml vial every 20 minutes once to three times with a half-milligram Pulmicort vial every 20 minutes for three times will be prescribed and for the control group, 2.5 ml deoulin nebulization will be prescribed in the first stage and repeated every 20 minutes up to three times.
Main outcome variables
The amount of hospitalization hours in the emergency department and Measuring the extent of disease severity reduction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210830052333N1
Registration date:2021-10-13, 1400/07/21
Registration timing:registered_while_recruiting
Last update:2021-10-13, 1400/07/21
Update count:0
Registration date
2021-10-13, 1400/07/21
Registrant information
Name
maryam khodayar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7628 5411
Email address
khodayar@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hospitalization time with deoulin nebulizer, deoulin nebulizer with inhalation spray and deoulin nebulizer and pulmicort simultaneously in patients with chronic obstructive pulmonary disease in the disease exacerbation stage
Public title
Comparison of hospitalization time of patients with different treatments of deoulin nebulizer, deoulin nebulizer with inhalation spray and deoulin nebulizer and pulmicort simultaneously in patients with chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 80 years;
Patients with confirmed diagnosis of chronic obstructive pulmonary disease by spirometric and clinical findings;
Chronic illness for at least the last six months;
Do not take any antibiotics for at least the last month;
Conscious consent to participate in research.
Exclusion criteria:
Loss of consciousness;
Severe restlessness;
Severe respiratory distress with oxygen pressure less than 60 mm Hg and carbon dioxide pressure greater than 45 mm Hg in a venous gas sample;
Severe heart failure;
Pulmonary embolism;
Use of any opium in the past month;
Existence of severe infectious diseases of the respiratory tract for at least one month;
History of any surgery on the respiratory tract.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
174
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were allocated to two intervention groups and one control groups according to random allocation table that illustrated by a statistician. Randomization was done using permuted block randomization method (Block size was 4) using blocked random allocation syntax in SPSS software. For calculation sample size was 174 and number of blocks was 44. Allocation concealment was done using closed opaque envelope.
Blinding (investigator's opinion)
Not 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 Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences; 7 Tir squer, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616611151
Approval date
2020-05-12, 1399/02/23
Ethics committee reference number
IR.SHMU.REC.1399.029
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44.1
ICD-10 code description
Chronic obstructive pulmonary disease with (acute) exacerbation
Primary outcomes
1
Description
The amount of hospitalization hours in the emergency department
Timepoint
Once an hour
Method of measurement
Count the hours of hospitalization
2
Description
Measuring the extent of disease severity reduction
Timepoint
Once an hour
Method of measurement
By counting the number of breaths per minute
3
Description
Maximum expiratory volume per the first second (FEV1)
Timepoint
Once an hour
Method of measurement
Micromedical spirometer
Secondary outcomes
1
Description
Measurement of arterial blood oxygen saturation
Timepoint
Once an hour
Method of measurement
Arterial blood oxygen measurement test with ABG device
2
Description
Measurement of venous blood carbon dioxide saturation
Timepoint
Once an hour
Method of measurement
Carbon dioxide test with ABG device
Intervention groups
1
Description
Intervention group 1: For the first intervention group, in addition to routine treatments including oxygen therapy, deoulin nebulization (salbutamol + ipratropium bromide) in a 2.5 ml vial every 20 minutes once to three times with salbutamol and atrovent sprays 8 puffs and repeat both sprays up to three times every 20 minutes with the use of asmyar will be prescribed .
Category
Treatment - Drugs
2
Description
Intervention group 2: For the second intervention group, in addition to routine treatments including oxygen therapy, deoulin nebulization (salbutamol + ipratropium bromide) in a 2.5 ml vial every 20 minutes once to three times with a half-milligram Pulmicort vial every 20 minutes for three times will be prescribed .
Category
Treatment - Drugs
3
Description
Control group: For the control group, in addition to routine treatments including oxygen therapy, 2.5 ml deoulin nebulization will be prescribed in the first stage and repeated every 20 minutes up to three times.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital of Shahroud
Full name of responsible person
Dr. Maryam khodayar
Street address
Imam Hossein Hospital., End Imam street., Shahroud , Iran.
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
khodayar@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hassan Emamian
Street address
Vice chancellor for research; Shahroud University medical Sciences ,7th Tir squar, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Phone
+98 23 3239 4499
Fax
+98 23 3239 4800
Email
pajouhesh@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research; Shahroud University medical and 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
Shahroud University of Medical Sciences
Full name of responsible person
Parisa Soleymani
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossein Hospital, End Imam street, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
parisasoleimani1073@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Maryam Khodayar
Position
professor assistant
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam Hossein hospital., End Imam street., Shahroud., Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
khodayar@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Maryam Khodayar
Position
Professor assistant
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Imam Hossein Hospital, End Imam street, Shahroud, Iran
City
shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
khodayar@shmu.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