- Determining the effectiveness of rescue blankets on patients' cold discomfort scale
- Determining the effectiveness of conventional blankets on patients' cold discomfort scale
- Determining the effectiveness of rescue blankets on patients' vital signs
- Determining the effectiveness of conventional blankets on patients' vital signs
Design
Two arm parallel group randomised trial with non-blinded outcome assessment
Settings and conduct
All patients who are transferred from the scene to the emergency department of Hospital, meet the inclusion and exclusion criteria, will be entered in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Age over 18-year-old
- Cold discomfort scale over 2
Exclusion criteria:
- Glasgow coma scale less than 15
- Transfer time from scene to hospital less than 10 minutes
- Transfer with helicopter
Intervention groups
In one group, patients are covered by a rescue blanket from the scene to the hospital during transferring by emergency medical service, and in the other group, conventional blankets are used for patients.
Main outcome variables
Cold discomfort scale
Vital signs including tympanic temperature, blood pressure, pulse rate, respiratory rate and O2-saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190416043288N1
Registration date:2019-04-24, 1398/02/04
Registration timing:retrospective
Last update:2019-04-24, 1398/02/04
Update count:0
Registration date
2019-04-24, 1398/02/04
Registrant information
Name
Alireza Baratloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 1432
Email address
arbaratloo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
2019-02-20, 1397/12/01
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-04-20, 1398/01/31
Scientific title
Comparison of rescue blankets with conventional blankets to prevent hypothermia in patients transmitted by emergency medical service
Public title
Efficiency of Rescue Blankets vs.Conventional Blankets in Pre-Hospital Phase
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18-year-old
Cold Discomfort Scale over 2
Exclusion criteria:
Glagcow coma scale less than 15
Transfer time from the scene to the hospital less than 10 minutes
Transmission with helicopter
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Actual sample size reached:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Two regional ambulance stations were selected to participate in this study, which transmits patients to a single hospital. One uses rescue blanket during transferring all patients. Another one use conventional blanket for transferring all patients.
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
Vice Chancellor in Research Affairs - Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, Ghods Sreet, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-03-08, 1397/12/17
Ethics committee reference number
IR.TUMS.VCR.REC.1397.1092
Health conditions studied
1
Description of health condition studied
Traumatic and non-traumatic patients transferred to the hospital by emergency medical service
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The severity of the patient discomfort from the cold
Timepoint
Before moving the ambulance from the scene and at the time of the patient's delivery to the emergency department of the destination hospital
Method of measurement
Cold Discomfort Scale
2
Description
Patient's body temprature
Timepoint
Before moving the ambulance from the scene and at the time of the patient's delivery to the emergency department of the destination hospital
Method of measurement
Tympanic temperature
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before moving the ambulance from the scene and at the time of the patient's delivery to the emergency department of the destination hospital
Method of measurement
Millimeter mercury
2
Description
Pulse rate
Timepoint
Before moving the ambulance from the scene and at the time of the patient's delivery to the emergency department of the destination hospital
Method of measurement
Beat per minute
3
Description
Respiratory rate
Timepoint
Before moving the ambulance from the scene and at the time of the patient's delivery to the emergency department of the destination hospital
Method of measurement
number per minute
4
Description
O2 saturation
Timepoint
Before moving the ambulance from the scene and at the time of the patient's delivery to the emergency department of the destination hospital
Method of measurement
Pulse oximetery
Intervention groups
1
Description
Intervention group: In order to prevent hypothermia for patients, a rescue blanket is used in ambulance during the transfer from the scene to the destination hospital.
Category
Prevention
2
Description
Control group: In order to prevent hypothermia for patients, a conventional blanket is used in ambulance during the transfer from the scene to the destination hospital.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Emergency Medical Center
Full name of responsible person
Parisa Hasani
Street address
No 86, Khalilabadi Boulevard, Sattari highway
City
Tehran
Province
Tehran
Postal code
1473745861
Phone
+98 21 4923 1000
Fax
+98 21 4489 6347
Email
parisahasaniems@gmail.com
Web page address
http://umsha.ac.ir/includes/plink.aspx?linkid=62
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Emergency Medical Service
Full name of responsible person
Peyman Saberian
Street address
No 86, Khalilabadi Boulevard, Sattari Highway
City
Tehran
Province
Tehran
Postal code
1473745861
Phone
+98 21 4923 1000
Fax
+98 21 4489 6347
Email
peymansaberian61@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Emergency Medical Service
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran Emergency Medical Service Center
Full name of responsible person
Parisa Hasani
Position
Head of Research Department
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 86, Khalilabadi Boulevard, Sattari Highway
City
Tehran
Province
Tehran
Postal code
1473745861
Phone
+98 21 4923 1000
Email
parisahasaniems@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Baratloo
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
ِEmergency Department, Sina Hospital, Hasanabad Square
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1432
Email
arbaratloo@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran Emergency Medical Service Center
Full name of responsible person
Parisa Hasani
Position
Head of Research Department
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 86, Khalilabadi Boulevard, Sattari Highway
City
Tehran
Province
Tehran
Postal code
1473745861
Phone
+98 21 4923 1000
Email
parisahasaniems@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The raw data and coded information of the patients participating in the study can be provided.
When the data will become available and for how long
There is no specific time period.
To whom data/document is available
Persons with academic position
Under which criteria data/document could be used
In order to design and conduct future studies in this field
From where data/document is obtainable
Contact with email of parisahasaniems@gmail.com
What processes are involved for a request to access data/document
After confirmation of the applicant's identity, we will contact him/her by email.