Protocol summary

Study aim
Study of the effect of rewarming on the outcome of injury, injury severity and arterial blood gases in hospitalized patients in the emergency department
Design
In this study, 70 trauma patients referred to the Mousavi Hospital of Zanjan, by using a Poisson model and a randomized block (randomized) block design with two groups of control and test in blocks of 6 whose block number Randomized random number tables, entry and arrangement of patients to each of the groups based on the criteria for entering the number of blocks, respectively.
Settings and conduct
Patients with trauma who will be admitted in the Mousavi Hospital of Zanjan after being randomly assigned to two groups, the Trauma Control usual treatment and the Test Group as intervention. Intervention is based on intervention rewarming strategies in the form of a temperature control package that includes several rewarming strategies (based on clinical parameters and active or passive techniques rewarm up with an intervention strategy for wounding the injured, avoiding the placement Getting to the cold, warm, and setting the ambient temperature, using a blanket of linen with a waterproof layer and disposable elastic cap with foil, injections of warm liquids by heating the blood and fluids by checking and recording the Signs of vital importance include central body temperature, heart rate, respiratory rate and blood pressure per hour First (every 15 minutes) and 6 hours later, until the normal temperature is reached, the test is performed for the test group. For the control group, the usual care is taken and the patient's patient care unit is installed. The research data were first collected during and after the intervention using a questionnaire prepared by the researcher including demographic and traumatic information are collected in two groups..
Participants/Inclusion and exclusion criteria
The criteria for entering the study include trauma patients aged 18-65 years old, with a central temperature of less than 38 ° C and above 28 ° C, without loss of consciousness, a transfer time to the center of less than one hour, and a higher ISS score 9 and less than 40. Exclusion criteria: progression toward severe hypothermia (body temperature below 28 ° C), exiting from the emergency room earlier than 6 hours, death less than 24 hours after admission to the emergency room, decreased GCS alertness Less than 13 at each stage of the intervention, cardiopulmonary arrest before reaching the center or at any stage of the intervention and dissatisfaction of the patient or his family.
Intervention groups
The study population consisted of all trauma patients admitted to the emergency department of Ayatollah Mousavi Hospital in Zanjan. After the random sampling (random block), the blocks were randomly assigned to control and test groups. Six blocks were selected from the random numbers table. The arrangement of patients to each group will be based on the criteria for entry in the order number of the blocks.
Main outcome variables
Injury outcome; injury severity; arterial blood gases of trauma patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151112025009N2
Registration date: 2018-03-04, 1396/12/13
Registration timing: registered_while_recruiting

Last update: 2018-03-04, 1396/12/13
Update count: 0
Registration date
2018-03-04, 1396/12/13
Registrant information
Name
Mohammadreza Dinmohammadi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3315 6912
Email address
mdinmohammadi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rewarming on injury outcome, injury severity and arterial blood gases of trauma patients hospitalized in emergency department
Public title
The effect of rewarming on injury outcome, injury severity and arterial blood gases of trauma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with traumatic ranges aged 18-65 years old with a core temperature of less than 38 ° C and above 28 ° C Without loss of consciousness Transfer time to the center of less than one hour ISS score above 9 And less than 40
Exclusion criteria:
Progression to severe hypothermia (core body temperature below 28 ° C) Exits from the emergency less than 6 hours Death less than 24 hours after admission Decreased GCS awareness less than 13 At each stage of the intervention, cardiopulmonary arrest before reaching the center or at any stage of intervention and dissatisfaction of the patient or his family
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
This study was a clinical trial with control group. The reheat approach is carried out by the researcher responsible for the study at the time until the sample size is completed. The study population consisted of all trauma patients admitted to emergency department of Ayatollah Mousavi Hospital in Zanjan. After determining the sample size, this study was performed using Poisson's model (so that according to the sample size the duration of intervention was determined) and by random sampling (block) randomized block with two groups of control and test in Blocks 6 The number of blocks from the random number table, the entry and arrangement of patients to each of the groups will be based on the criteria for entering the number of blocks, respectively. The usual care group will receive the trauma and reheat test group as intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Azadi Square - Beginning of the Islamic Republic Boulevard - Central Station of Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4515789589
Approval date
2017-10-03, 1396/07/11
Ethics committee reference number
IR.ZUMS.REC.1396.163

Health conditions studied

1

Description of health condition studied
Hypothermia
ICD-10 code
T68
ICD-10 code description
Hypothermia

Primary outcomes

1

Description
Determination and comparison of death rate, admission rate, hospitalization period, injury severity and arterial blood gas levels in hospitalized patients in the emergency department of Ayatollah Mousavi Hospital in Zanjan in the control and test groups.
Timepoint
Measurement of central temperature at the first hour (every 15 minutes) and 6 hours to reach normal temperature - Arterial blood gases taken at one hour and six hours after hospitalization - Measuring the deterioration of the injury with the standard ISS, RTS- Track the patients' situation after ten days of the incident
Method of measurement
Tympanic thermometer digital - Machines ABG optimedical - measure the severity of the injury criteria (Injury Severity Score Revised Trauma Score)

Secondary outcomes

1

Description
injury outcome (length of stay in hospitals, admission to the intensive care unit, death)
Timepoint
Deaths up to 10 days
Method of measurement
Medical documents

2

Description
Injury Severity
Timepoint
Admission, at the first hour, six hours later, if admitted to the special department
Method of measurement
Revised Trauma Score

3

Description
Arterial blood gas
Timepoint
Before intervention 6 and 12 hours later intervention
Method of measurement
Radial artery blood sampling

Intervention groups

1

Description
Intervention group: they will receive rewarming strategies (wear wet clothes, avoid getting cold, warm, and adjusting the ambient temperature, using a suitable blanket of linen linen with a waterproof layer, a disposable cap with a foil layer, injections of warm veins with a blood heater and liquids )according to the entry criteria.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
بخش اورژانس مرکز آموزشی درمانی آیت الله موسوی زنجان
Full name of responsible person
سارا صادقی محمدی
Street address
Central Station of Zanjan University of Medical Sciences-Beginning of the Islamic Republic Boulevard - Azadi Square-Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8318
Fax
+98 24 3314 8319
Email
sara.sadeghimohammad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Sara Sadeghi Mohammadi
Street address
Central Station of Zanjan University of Medical Sciences-Beginning of the Islamic Republic Boulevard - Azadi Square-Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 4771
Fax
+98 24 3342 4774
Email
sara.sadeghimohammad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Sara Sadeghi Mohammadi
Position
MSN
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zanjan - Azadi Square - Beginning of the Islamic Republic Boulevard - Central Station of Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 4771
Fax
+98 24 3342 4774
Email
sara.sadeghimohammad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammadreza Dinmohammadi
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zanjan - Azadi Square - Beginning of the Islamic Republic Boulevard - Central Station of Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 4771
Fax
+98 24 3342 4774
Email
mdinmohammadi@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammadreza Dinmohammadi
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zanjan - Azadi Square - Beginning of the Islamic Republic Boulevard - Central Station of Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 4771
Fax
+98 24 3342 4774
Email
mdinmohammadi@zums.ac.ir

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
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The data on the primary and secondary consequences can be shared.
When the data will become available and for how long
Start of access from the second half of 1397
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
It can be used in coordination with the scientific authority
From where data/document is obtainable
mdinmohammadi@zums.ac.ir
What processes are involved for a request to access data/document
Contact by email with the scientific project manager
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