Effect of variation in ambient temperature on vital signs and cardiac indices in echocardiography among healthy volunteer adults: a before-after clinical trial
To assess the effect of variation in ambient temperature on vital signs and cardiac indices in echocardiography among healthy volunteer adults: a before-after clinical trial
Design
This is a before-after clinical trial, in which 20 eligible healthy volunteer adults will be enrolled
Settings and conduct
The eligible healthy volunteer adults will be invited to the Besat Hospital in Hamadan City
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 55 years
Healthy adults class ASA one and two
Exclusion criteria:
Presence of any chronic or background disease
Intervention groups
Intervention group:
The ambient temperature from the base of 23 °C every two degrees for two minutes to a maximum of 39 °C
Main outcome variables
Measuring systolic and diastolic blood pressure
Measuring arterial blood pressure a
Measuring the number of breathing
Measuring heart rate
Measuring the changes in the walls of the heart cavity
Measuring central and tympanic
Measuring consciousness level
Measuring arterial oxygen percentage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N274
Registration date:2019-05-11, 1398/02/21
Registration timing:prospective
Last update:2019-05-11, 1398/02/21
Update count:0
Registration date
2019-05-11, 1398/02/21
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of variation in ambient temperature on vital signs and cardiac indices in echocardiography among healthy volunteer adults: a before-after clinical trial
Public title
Effect of variation in ambient temperature on vital signs and cardiac indices in echocardiography among healthy volunteer adults
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 55 years
Healthy adults class ASA one and two
Exclusion criteria:
Presence of any chronic or background disease
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-05-04, 1398/02/14
Ethics committee reference number
IR.UMSHA.REC.1398.082
Health conditions studied
1
Description of health condition studied
Healthy volunteer adults
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measuring systolic and diastolic blood pressure
Timepoint
At supine position 2 minutes after intervention
Method of measurement
With a monitor device
2
Description
Measuring arterial blood pressure
Timepoint
At supine position 2 minutes after intervention
Method of measurement
With a monitor device
3
Description
Measuring the number of breathing
Timepoint
At supine position 2 minutes after intervention
Method of measurement
With a monitor device
4
Description
Measuring heart rate at supine position 2 minutes after intervention
Timepoint
At supine position 2 minutes after intervention
Method of measurement
With a monitor device
5
Description
Measuring the changes in the walls of the heart cavity
Timepoint
At supine position 2 minutes after intervention
Method of measurement
With echocardiography
6
Description
Measuring central and tympanic
Timepoint
At supine position 2 minutes after intervention
Method of measurement
With a monitor device
7
Description
Measuring consciousness level
Timepoint
At supine position 2 minutes after intervention
Method of measurement
With a clinical examination and GCS
8
Description
Measuring arterial oxygen percentage
Timepoint
At supine position 2 minutes after intervention
Method of measurement
With a monitor device
9
Description
Measurement of strike volume
Timepoint
At supine position 2 minutes after intervention
Method of measurement
With echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The ambient temperature from the base of 23 °C every two degrees for two minutes to a maximum of 39 °C
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan City
Full name of responsible person
Dr Abbas Taher
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
t_anesthesia@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Abbas Taher
Position
Anesthesiologist
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
t_anesthesia@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Abbas Taher
Position
Anesthesiologist
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
t_anesthesia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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