This study will be done by the aim of comparing the effects of active cooling and wet sponging to reduce the body temperature of febrile patients who are admitted to Qazvin city intensive care units. Inclusion criteria are patients who are admitted to intensive care units in Qazvin educational hospitals with tympanic temperature on 38.3 and below 40 degrees centigrade and between 18 and 65 years of age, exclusion criteria are steroid prescription, reaching the fever above 40 degrees and shivering. Study population are patients who are admitted to intensive care unit health centers affiliated to Qazvin University of Medical Sciences with tympanic temperature above 38.3 degrees centigrade. The study is carried out in four groups of 18 and a total sample size of 72. One group will receive just wet sponging. The second group will be directed to the flow of air at room temperature. The third one will receive a combination of those two methods and the forth will received no physical treatment to reduce fever. All four groups will receive acetaminophen 30 minutes after fever onset and interventions will be started immediately in the three intervention groups. In all groups, interventions will be continued until tympanic temperature will reduce to 37 degrees or 4 hours passed from the start of the intervention, patient`s vital sign will record every 30 minutes and reduce fever as the primary outcome is checked
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012092910963N1
Registration date:2013-02-15, 1391/11/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-15, 1391/11/27
Registrant information
Name
Marjan Haghi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1333 8034
Email address
mhaghi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
thesis
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-06-20, 1392/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of active cooling and wet sponging to reduce the body temperature in Intensive Care Unit febrile patients: A factorial design
Public title
Active cooling effect on fever reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who are admitted to intensive care units in Qazvin educational hospitals; Tympanic temperature on 38.3 and below 40 degrees centigrade; above 18 and below 65 years of age; Do not having AIDS; non pregnant; do not having renal failure; do not recieve chemotherapy; do not having acute electrolyte disorders;do not recieve steroid; do not having respiratory infections; do not having severe diarrhea; have adequate hydration; do not received blood products in the past 24 hours; do not received Ayntralypyd in the past 24 hours; more than 24 hours of starting treatment with antibiotics is passed.
Exclusion criteria: Reaching the fever obove 40 degrees centigrade; All confirmed and suspected cases of fever due to hypothalamic dysfunction; different physical method which is prescribed by the physician; antibiotic change in the 4-hour intervention; Ayntralypyd and blood products administered during the intervention; any changes in ventiation; shivering.
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:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin university of medical sciences
Street address
Shahid Bahonar Blv
City
Qazvin
Postal code
Approval date
2012-12-03, 1391/09/13
Ethics committee reference number
D/20/5256
Health conditions studied
1
Description of health condition studied
Fever
ICD-10 code
R50
ICD-10 code description
Fever of other and unknown origin
Primary outcomes
1
Description
tympanic temperature
Timepoint
every 30 minutes until 4 hours
Method of measurement
degrees centigrade
Secondary outcomes
1
Description
shivering
Timepoint
every 30 minutes until 4 hours
Method of measurement
observation
Intervention groups
1
Description
wet sponging Intervention group: In this case the temperature of water will be one degree lower than ambient temperature and the standard gas is used.
Category
Treatment - Other
2
Description
Intervention airflow group: The direct flow of air at room temperature is given. In this method, the upper half of the body and legs from the knee to the down will be exposed to the airflow of Pars Khazar fan 3010 model with rotation speed of 1025 rpm, the air velocity of 205 meters per minute, air volume of 54 cubic meters per minute. In this way, the fan is placed at a distance of 30 cm at the bottom of the patient's foot.
Category
Treatment - Other
3
Description
3 rd Intervention group : combination of air flow and fanning
Category
Treatment - Other
4
Description
control group : no physical treatment
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bou Ali Sina Hospital
Full name of responsible person
Marjan Haghi
Street address
Bou Ali Street
City
Qazvin
2
Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Marjan Haghi
Street address
Taavon Square, 22 Bahman Blv, Elahyeh
City
Qazvin
3
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Marjan Haghi
Street address
Kowar Alley, Shahid Taleghani Street
City
Qazvin
4
Recruitment center
Name of recruitment center
Shahid Rajaee Hospital
Full name of responsible person
Marjan Haghi
Street address
Padegan Street
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research - Qazvin University of Medical Science
Full name of responsible person
Dr. Saeed Asef Zadeh
Street address
Vice-chancellor for research, Qazvin University of Medical Sciences, Bahonar Bla, Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research - Qazvin University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin university of medical sciences
Full name of responsible person
marjan haghi
Position
Student
Other areas of specialty/work
Street address
Shahid ba honar blv
City
Qazvin
Postal code
Phone
+98 21 8825 6336
Fax
Email
marjanhaghi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin university of medical sciences
Full name of responsible person
marjan haghi
Position
Student
Other areas of specialty/work
Street address
shahid bahonar blv
City
Qazvin
Postal code
Phone
+98 21 8825 6336
Fax
Email
marjanhaghi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Scenices
Full name of responsible person
Marjan Haghi
Position
Student
Other areas of specialty/work
Street address
Nursing Faculty, Qazvin University of Medical Sciences, Bahonar Blv, Qazvin
City
Qazvin
Postal code
Phone
+98 28 1333 8034
Fax
Email
mhaghi@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)