Protocol summary

Study aim
comparison of effects of nebulised Fursemide, oxygen and placebo in patients with acute dyspnea transmited to hospitals by EMS
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 300 patients. In order to randomize, the block randomization method will be used.
Settings and conduct
In this study, All patients with acute dyspnea transferred to hospitals by emergency will be enrolled. Patients will be randomly divided into 3 groups based on Blocks with size 12. The sample size for each study group is 100. A total of 300 patients will be examined. Patients and data analyzer will be blind.
Participants/Inclusion and exclusion criteria
All patients with acute dyspnea transferred to hospitals by emergency will be enrolled. Inclusion criteria: Patient transfer by pre-hospital emergency, patients over 18 years, . Exclusion criteria: patients over 75 years, Patients require mechanical ventilation, Loss of consciousness, Accompanied by another disease that requires treatment in the first 10 minutes of treatment with digoxin, beta-blocker, beta-agonist and calcium blocker, Need another inhalation treatment in the first 10 minutes, Need non-invasive positive pressure ventilation
Intervention groups
Intervention group 1: In addition to routine treatment, 40 mg of inhaled furosemide will be given as a nebulizer at the scene. Intervention group 2: In addition to routine treatment, oxygen will be administered at the scene with a mechanical nebulizer. Control group: In addition to routine treatment, 10 cc of normal saline will be prescribed as a placebo at the scene.
Main outcome variables
Acute dyspnea; Percentage of oxygen saturation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151003024317N12
Registration date: 2020-11-10, 1399/08/20
Registration timing: prospective

Last update: 2020-11-10, 1399/08/20
Update count: 0
Registration date
2020-11-10, 1399/08/20
Registrant information
Name
Mahdi Rezai
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 6772
Email address
rezaei.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of effects of nebulised Furosemide, oxygen and placebo in patients with acute dyspnea transmited to hospitals by EMS
Public title
Evaluation of the effect of nebulised Furosemide on acute dyspnea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute dyspnea Patient transfer by pre-hospital emergency patients over 18 years old
Exclusion criteria:
patients over 75 years old Patients require mechanical ventilation Loss of consciousness Accompanied by another disease that requires treatment in the first 10 minutes of treatment with digoxin, beta-blocker, beta-agonist and calcium blocker Need another inhalation treatment in the first 10 minutes Need non-invasive positive pressure ventilation
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to tree groups by using a random number table. In order to randomize, a random block method will be used. For this purpose, we formed blocks of size 12. In each block, 4 individuals will be in intervention group 1, 4 individuals will be in intervention group 2 and 4 will be in control group. A total of 25 blocks will be considered for the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Clinical caregivers and patients will be unaware and blind to the type of treatment. Similar serums were used for concealment, without drug name label and only with code. Patients will be aware that they will be randomly assigned to one of three treatment groups, but will not know which treatment will be offered in that group. Patients will be placed in one of three groups using a random number table. The clinician also knows that patients will be treated in three different ways, but will not know which method will be used for each patient. The data collector, analyst, outcome assessor, and data safety and monitoring committee will collect and analyze the information based on groups 1, 2, and 3, and will not be aware of the type of treatment provided in the groups. They will be kept blind.
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, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-10-07, 1399/07/16
Ethics committee reference number
IR.IUMS.REC.1399.632

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
Acute dyspnea
Timepoint
Before intervention, thirty minutes after intervention
Method of measurement
Shortness of breath chart

2

Description
Percentage of oxygen saturation
Timepoint
Before intervention, thirty minutes after intervention
Method of measurement
Percentage of oxygen saturation

Secondary outcomes

1

Description
Heart rate
Timepoint
Before intervention, thirty minutes after intervention
Method of measurement
Based on the information recorded in patient's record

2

Description
Number of breaths
Timepoint
Before intervention, thirty minutes after intervention
Method of measurement
Based on the information recorded in patient's record

Intervention groups

1

Description
Intervention group 1: In addition to routine treatment, 40 mg of inhaled furosemide will be given as a nebulizer at the scene.
Category
Treatment - Drugs

2

Description
Intervention group 2: In addition to routine treatment, oxygen will be prescribed at the scene with a mechanical nebulizer.
Category
Treatment - Drugs

3

Description
Control group: In addition to routine treatment, 10 cc of normal saline will be prescribed as a placebo at the scene.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Rasoul Akram hospital
Full name of responsible person
Babak Mahshidfar
Street address
Emergency department, Hazrate Rasool hospital, Niyayesh street, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2190
Email
hrmc@iums.ac.ir

2

Recruitment center
Name of recruitment center
Firouzgar hospital
Full name of responsible person
Babak Mahshidfar
Street address
Vali Asr Sq. Beh Afarin Ave.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
h_firoozgar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevallian
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
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
Assistant Professor of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Hazrate Rasool hospital, Niyayesh street, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2190
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
Assistant Professor of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Hazrate Rasool hospital, Niyayesh street, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2190
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
Babak Mahshidfar
Position
Assistant Professor of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Hazrate Rasool hospital, Niyayesh street, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2190
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
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