Comparing the effects of wearing of elastic sucks with leg elevation on preventing hypotension in patients undergoing plasmapheresis
Design
A randomized clinical trial that includes a control group with 3 methods ; wearing elastic socks, lower limb elevation and using both of them. Patients will be grouped in parallel permutation blocks. The number of samples are 35 people. Each patient is required to attend 4 sessions , so that 140 plasmapheresis sessions will be performed for all patients.
Settings and conduct
This study will be implemented to prevent hypotension caused by plasmapheresis; The study will be conducted in Sina hospital in Hamedan city, which includes all patients referring for plasmapheresis who have necessary qualifications for the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All Patients were candidates for plasmapheresis, at least 4 sessions in a day
interval
Age 20 to 60 years
Minimum volume of plasma separation 1.5 liters
Plasmapheresis time, 3 to 4 hours
Patient alertness
Exclusion criteria:
Use of medications that affect blood pressure over the past 24 hours
Any prohibition on measuring blood pressure and upper limb pulse
Any prohibition on wearing elastic socks or lifting legs
Pregnancy
Patient's unwillingness to participate in the study
Cardiovascular disease and severe anemia
Intervention groups
Method A, using of elastic socks
Method B, raising the lower limbs
Method C, simultaneous using of elastic socks and raising the lower limbs
Method D, the control group
Main outcome variables
Blood pressure and pulse rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191020045166N1
Registration date:2020-01-17, 1398/10/27
Registration timing:registered_while_recruiting
Last update:2020-01-17, 1398/10/27
Update count:0
Registration date
2020-01-17, 1398/10/27
Registrant information
Name
Armin mohamadiparsa
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3272 7710
Email address
armin94g@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effects of Wearing of Elastic Socks with Leg Elevation on preventing Hypotension in patients undergoing Plasmapheresis
Public title
The Effect of Nursing Interventions on the Preventing Hypotension in Patients Undergoing Plasmapheresis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients undergoing plasmapheresis for at least 4 sessions with at least one day interval
Age 20 to 60 years
The minimum volume of plasma separation should be 1.5 liters
The duration of plasmapheresis is between 3 and 4 hours
Patient alertness
Exclusion criteria:
Cardiovascular disease and severe anemia
Use of medications that affect blood pressure over the past 24 hours
Any prohibition on measuring blood pressure and upper limb pulse
Any prohibition on wearing elastic socks or lifting legs
Pregnancy
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
More than 1 sample in each individual
Number of samples in each individual:
4
.
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be grouped by permutation blocks, So that each combination of ABCD, BCAD, CDAB and DABC will be placed in a separate envelope to the same count of patient so at first we select a patient who chooses an envelope randomly; for example if ABCD sequence is selected, method A will be run at first then B and respectively C and D.
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
Ethics Committee of Hamedan University of Medical Sciences
Street address
Fahmide Street, Hamedan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838698
Approval date
2019-10-28, 1398/08/06
Ethics committee reference number
IR.UMSHA.REC.1398.613
Health conditions studied
1
Description of health condition studied
Prevention of Hypotension due to Plasmapheresis
ICD-10 code
I95
ICD-10 code description
Hypotension
Primary outcomes
1
Description
Blood Pressure
Timepoint
Before starting the process and then at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours and finally half an hour after the end
Method of measurement
Portable Blood Pressure Monitor
2
Description
Pulse Rate
Timepoint
Before starting the process and then at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours and finally half an hour after the end
Method of measurement
Pulse Oximeter Device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: In addition to receiving routine care, the patient also uses elastic socks; at the beginning of the plasmapheresis session, the patient wears elastic socks and is maintained until the end of the session, Also at the start, during and after the intervention, the patient's blood pressure and pulse are recorded.
Category
Prevention
2
Description
Intervention group B: In addition to receiving routine care, the patient's legs are raised 45 degrees at the start of the session and this position is maintained until the end of the plasmapheresis and the patient's blood pressure and pulse rate are recorded during the session.
Category
Prevention
3
Description
Intervention group C: At the beginning of plasmapheresis, elastic socks are used to raise the legs 45 degrees simultaneously until the end of the session and the patient's blood pressure and pulse are recorded during plasmapheresis.
Category
Prevention
4
Description
Control group: The patient does not receive any intervention and only the routine care for patients during plasmapheresis will be implemented and the patient's blood pressure and pulse are recorded during the session
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital of Hamedan
Full name of responsible person
Mahyar Motaghed
Street address
Mirzadeh Eshghi Street
City
Hamedan
Province
Hamadan
Postal code
6516848741
Phone
+98 81 3827 9345
Email
farsh_hamedan@umsha.ac.ir
Web page address
http://fsh.umsha.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Shahid Fahmideh Boulevard
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
Info.Research@umsha.ac.ir
Web page address
http://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
Armin Mohamadiparsa
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No20, Meraj street, Amirkabir
City
Hamedan
Province
Hamadan
Postal code
6515819173
Phone
+98 81 3272 7710
Fax
Email
armin94g@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Armin Mohamadiparsa
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No20, Meraj street, Amirkabir
City
Hamedan
Province
Hamadan
Postal code
6515819173
Phone
+98 81 3272 7710
Fax
Email
armin94g@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Armin Mohamadiparsa
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No20, Meraj street, Amirkabir
City
Hamedan
Province
Hamadan
Postal code
6515819173
Phone
+98 81 3272 7710
Fax
Email
armin94g@gmail.com
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