comparison of effects of nebulised Frusemide and placebi in patients with acute dyspnea transmited by EMS
Design
randomized, parallel group with blinded,
Settings and conduct
in Tehran EMS, in ambulances of Tehran
Participants/Inclusion and exclusion criteria
All the patients with acute dyspnea will be included in the study.
Exclusion criteria: not willing to participate in the study, history of susceptibility to sulfa drugs, unstable hemodynamics; requiring mechanical ventilation; decreased consciousness, accompany with another illness requiring treatment in the first 10 minutes of treatment with digoxin, beta blocker, beta-agonist and calcium; need to have another inhaling treatment in the first 10 minutes and need to have non-invasive ventilation.
Intervention groups
all patients 18 to 75 years old devided in 3 groups; for first group nebulized Furosemide, second group nebulized placebo and for third group nothing nebulized.
Main outcome variables
pulse rate, respiratory rate, visual analogue score, O2 saturation, need to mechanical ventilation in hospital
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171014036753N2
Registration date:2019-01-08, 1397/10/18
Registration timing:registered_while_recruiting
Last update:2019-01-08, 1397/10/18
Update count:0
Registration date
2019-01-08, 1397/10/18
Registrant information
Name
Babak Mahshidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 9255
Email address
mahshidfar.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-26, 1397/09/05
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of effects of nebulised Frusemide and placebi in patients with acute dyspnea transmited by EMS
Public title
comparison of effects of nebulised Frusemide and placebi in patients with acute dyspnea transmited by EMS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all patient between 18 to 75 years old with dyspnea who transmitted to hospitals by EMS
Exclusion criteria:
not willing to participate in the study
history of susceptibility to sulfa drugs
unstable hemodynamics; requiring mechanical ventilation; decreased consciousness, accompany with another illness requiring treatment in the first 10 minutes of treatment with digoxin, beta blocker, beta-agonist and calcium; need to have another inhaling treatment in the first 10 minutes and need to have non-invasive ventilation.
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
table of random numbures
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and EMS staff
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-05-09, 1397/02/19
Ethics committee reference number
IR.IUMS.FMD.REC1396.9411307033
Health conditions studied
1
Description of health condition studied
acute dyspnea
ICD-10 code
R06.0
ICD-10 code description
Dyspnea
Primary outcomes
1
Description
Oxygen saturation
Timepoint
baseline until arrive to hospital
Method of measurement
Pulse oximeter
2
Description
MMRC Dyspnea Severity Scale
Timepoint
baseline until arrive to hospital
Method of measurement
Visual Analouge Scale
Secondary outcomes
1
Description
severity of dyspnea
Timepoint
baseline until to arrive to hospital
Method of measurement
visual analogue scale by EMS staff
Intervention groups
1
Description
Intervention group: 40 milligram of Furosemide is inhaled through nebulizer in addition to routine treatment in ambulances
Category
Treatment - Drugs
2
Description
Control group: Normal Saline as a placebo will be prescribed through nebulizer in addition to routine treatment in ambulances
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
EMS in Thran
Full name of responsible person
Mojdeh Mirkheshti
Street address
No 86, Khalilabadi st, Sattari Expway Tehran
City
Tehran
Province
Tehran
Postal code
14492614535
Phone
+98 21 4923 1000
Email
research@tehran115.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Babak Mahshidfar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
mahshidfar.b@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Babak Mahshidfar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6653 9255
Email
mahshidfar.b@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojdeh Mirkheshti
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6653 9255
Email
mahshidfar.b@iums.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