Developing a comprehensive practical protocol for using point -of -care –ultrasonography in disposition of patients with acute non-traumatic dyspnea in emergency department
Developing a comprehensive practical protocol for using point -of -care –ultrasonography in disposition of patients with acute non-traumatic dyspnea in emergency department
Design
The design of the study is a randomized clinical trial. The randomization method is blocked. The sample size for each study group is 16.
Settings and conduct
In this research, all patients referred to the to the Emergency Department of Hazrate Rasool hospital in Tehran who suffered from acute dyspnea will be enrolled. Patients will be randomly divided into two groups based on 4 blocks. A total of 32 patients will be examined. Data analyzers will be blind.
Participants/Inclusion and exclusion criteria
All patients referred to the Emergency Department of Hazrate Rasool hospital in Tehran who suffered from acute dyspnea will be enrolled. Inclusion criteria: Patients with sudden dyspnea. Exclusion criteria: Patients under the age of 18, Patients with trauma, Patients with chest pain or suspected symptoms of ischemic heart disease.
Intervention groups
In the intervention group, in addition to the routine diagnostic protocol patients will be subjected to using point -of -care –ultrasonography upon arrival. IN control group: Diagnostic examinations and routine diagnostic protocol of the emergency department will performed.
Main outcome variables
The first diagnosis , The final diagnosis, Time to disposition of patient
General information
Reason for update
Acronym
POCUS
IRCT registration information
IRCT registration number:IRCT20111114008104N14
Registration date:2018-12-03, 1397/09/12
Registration timing:prospective
Last update:2018-12-03, 1397/09/12
Update count:0
Registration date
2018-12-03, 1397/09/12
Registrant information
Name
Mohammad Amin Zare
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 5327
Email address
ma-zare@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Developing a comprehensive practical protocol for using point -of -care –ultrasonography in disposition of patients with acute non-traumatic dyspnea in emergency department
Public title
The Effect of ultrasonography in disposition of patients
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with sudden dyspnea
Exclusion criteria:
Patients under the age of 18
Patients with trauma
Patients with chest pain or suspected symptoms of ischemic heart disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups. In order to randomize, a random block method will be used. For this purpose, we formed blocks with 4 person. In each block, 2 individuals will be in intervention group and 2 will be in control group. A total of 8 blocks will be considered for sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data will analyze by person who is blind to study groups (single blind).
Placebo
Not 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, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-07-21, 1396/04/30
Ethics committee reference number
IR.IUMS.REC.1396.31512
Health conditions studied
1
Description of health condition studied
Point -of -care –ultrasonography at the patient's arrival
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The first diagnosis
Timepoint
At the arrival of the patient
Method of measurement
Based on the information in the patient file
2
Description
The final diagnosis
Timepoint
After taking the medical treatment
Method of measurement
Based on the information in the patient file
3
Description
Time to disposition of patient
Timepoint
The time of transfer to the ordinary wards of hospital, being discharged or being observed in ED.
Method of measurement
Based on the information in the patient file
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to the routine diagnostic protocol, patients will be subjected to using point -of -care –ultrasonography upon arrival.
Category
Diagnosis
2
Description
Control group: Diagnostic examinations and routine diagnostic protocol of the emergency department will performed.