In this clinical study, 56 patients will be selected randomly and they will be divided into treatment and control groups using permuted block technique (4 patients in each block)
Settings and conduct
This research will be done on the patients hospitalized in ICU of "Bohlool" hospital that divided into control and treatment groups using one sided blind method
Participants/Inclusion and exclusion criteria
Inclusion criteria
Hospitalized in ICU under mechanical ventilation; Having order to receive 0.01-0.05 mg/kg of "Midazolam" and 5 µg/kg of "Fentanyl"
Exclusion criteria
Making an unstable status while doing treatments
Intervention groups
Pneumatic pump's cuff will be applied on treatment group in 3 phases, each phase 1 minute (45 seconds under pressure and 15 seconds of discharge) and there will be no treatment in control group by the researcher
Main outcome variables
Variations of hypotension
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190225042836N1
Registration date:2019-04-16, 1398/01/27
Registration timing:registered_while_recruiting
Last update:2019-04-16, 1398/01/27
Update count:0
Registration date
2019-04-16, 1398/01/27
Registrant information
Name
Amir Bagherzadeh bahabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 4058
Email address
bagherzadeh.a.stu@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-06, 1397/12/15
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pneumatic pumps on hypotension due to Midazolam and Fentanyl in patients admitted to the ICU
Public title
The Effect of using Pneumatic Pump on the Hypotension due to sedation in Patients Admitted to the ICU
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized in ICU under mechanical ventilation
Written consent form from patient's relatives (first degree relative)
Having order to receive 0.01-0.05 mg/kg "Midazolam" and 5 µg/kg "Fentanyl"
20 percent decrease in non-invasive blood pressure (MAP-SBP) to the initial non-invasive blood pressure
No ulcers, skin or vascular effects or fractures in the legs
Stable hemodynamics according to the ICU specialists
No Cardiovascular failure according to the patients medical history
Patients should be 20-80 years old
Exclusion criteria:
Making an unstable status while doing treatment
Contraindications for "Midazolam" or "Fentanyl" or both of them
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
From the research community who has the inclusion criteria, participants will be selected randomly and they will be divided into treatment and control groups using permuted block technique (4 patients in each block)
Blinding (investigator's opinion)
Single blinded
Blinding description
Non-invasive blood pressure will be measured by someone except the researcher
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Mahdizadeh Blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
969117433
Approval date
2019-02-20, 1397/12/01
Ethics committee reference number
IR.GMU.REC.1397.119
Health conditions studied
1
Description of health condition studied
Unspecified disorders of the circulatory system
ICD-10 code
I95.2
ICD-10 code description
Hypotension due to drugs
Primary outcomes
1
Description
Non-invasive blood pressure variations
Timepoint
Measuring non-invasive blood pressure before, instantly, 3 and 5 minutes after treatments
Method of measurement
Monitoring device
Secondary outcomes
1
Description
heart beat variation
Timepoint
Measuring heart beat before, instantly, 3 and 5 minutes after treatments
Method of measurement
Monitoring device
Intervention groups
1
Description
Intervention group: In supine mode, on patients that are hospitalized in ICU and receive "Midazolam" and "Fentanyl" according to the specialist's order, Pneumatic pump will be applied in 3 phases and under 35-45 mmHg pressure, each phase 1 minute (45 seconds under pressure and 15 seconds of discharge)
Category
Treatment - Other
2
Description
Control group: There will be no treatment in this group by the researcher
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bohlool hospital
Full name of responsible person
Amir Bagherzadeh bahabadi
Street address
'Bohlool" hospital, Vahdat blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691174333
Phone
+98 51 5723 6833
Fax
+98 51 5723 6833
Email
bohloolhospital@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Shahla Khosravan
Street address
Vice chancellor for research, Gonabad University of Medical Sciences, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691174333
Phone
+98 51 5722 5080
Email
bagherzadeh.a.stu@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Amir Bagherzadeh Bahabadi
Position
Critical Care Nursing Graduate Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 2, Danesh Ave.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691174333
Phone
+98 51 5722 4058
Email
bagherzadeh.a.stu@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Amir Bagherzadeh Bahabadi
Position
Critical Care Nursing Graduate Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 2, Danesh Ave.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691174333
Phone
+98 51 5722 4058
Email
bagherzadeh.a.stu@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Amir Bagherzadeh Bahabadi
Position
Critical Care Nursing Graduate Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bohlool Hospital, Vahdat Blvd.
City
Gonabad
Province
Razavi Khorasan
Postal code
9691174333
Phone
+98 51 5722 4058
Email
bagherzadeh.a.stu@gmu.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
A part of data
When the data will become available and for how long
6 months after publishing results
To whom data/document is available
Academic and Scientific researchers
Under which criteria data/document could be used
Observation of ethical principles from documentations