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The effect of passive movement of lower extremity on hemodynamic and ventilation parameters in patients under ventilator in intensive care unit

Protocol summary

Summary
The aim of this clinical trial study is to determine of the effect of passive movement of lower extremity on hemodynamic and ventilation parameters in patients under ventilator in intensive care unit. 64 patients under ventilator with lack of deep vein thrombosis, fracture or amputation of lower limbs; and spine injury who admitted to the intensive care unit, will select through convenience sampling and assignee to the intervention group and control group(with equal numbers) using block random allocation. At baseline, hemodynamic parameters such as systolic blood pressure, diastolic blood pressure, mean arterial pressure, arterial oxygen saturation, pulse rate, pulse pressure and temperature, and ventilation parameters such as respiratory rate, respiratory tidal volume, and respiratory minute volume of all samples will be record. While the control group will receive the routine treatment and cares, in the intervention group, in addition to routine treatment and cares, the nurses will do, protocol passive movement of the lower extremity consist of each leg rising, high and down and rotational movements on the ankles, bend and straighten of the knee, flexion and extension of hip joints for patients who are at semi setting in angle of 30 degrees during 22 minutes. Above hemodynamic and ventilation parameters will record Immediately, 2 hour, 6 hour,12 hour, and one day after passive movement of lower extremity in each study group, and data will analyze and compare.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016041727444N1
Registration date: 2016-09-04, 1395/06/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Rahman Rezaei kia
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5144
Email address
rahman.rezaeikia@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice ‍Chancellor for research, Yasuj University of Medical Science
Expected recruitment start date
2016-05-14, 1395/02/25
Expected recruitment end date
2016-06-14, 1395/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of passive movement of lower extremity on hemodynamic and ventilation parameters in patients under ventilator in intensive care unit
Public title
Impact of movement on patient's physiological indices
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: lack of deep vein thrombosis of lower extremities; lack of active rheumatoid arthritis; lack of fracture or amputation of lower limbs; absence of congenital anomalies in lower extremities; lack of congestive heart failure; Lack of spine injury; completion of written informed consent by legal guardian; and exclusion criteria will :Lack of legal guardian’s motivation for continue the cooperation; exacerbation of patient’s condition that continuation of intervention won’t possible; patient’s transfer to another Hospital; incidence of dangerous dysrhythmia; incidence of symptoms of intracranial pressure increase; death of patient
Age
From 15 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The patients as research units will select from study population who will eligible according inclusion criteria using convenience sampling, then assignee to intervention group and control group by block random allocation.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Deputy of research and technology, Yasuj University of Medical Science, Shahid Motahari Blvd.
City
Yasuj
Postal code
7591741417
Approval date
2016-04-18, 1395/01/30
Ethics committee reference number
IR.YUMS.REC.1395.4

Health conditions studied

1

Description of health condition studied
patients under mechanical ventilation
ICD-10 code
Z51.9
ICD-10 code description
Medical care, unspecified

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day after intervention
Method of measurement
According to mmhg using Saadat vital sign monitoring equipment (saadat S740) made in iran

2

Description
Diastolic blood pressure
Timepoint
Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day after intervention
Method of measurement
According to mmhg using Saadat vital sign monitoring equipment (saadat S740) made in iran

3

Description
Mean arterial blood pressure
Timepoint
At the beBefore intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day after interventionginning of study
Method of measurement
According to mmhg using Saadat vital sign monitoring equipment (saadat S740) made in iran and insert amounts in formula: [(Systolic blood pressure+2 Diastolic blood pressure)/3]

4

Description
O2 saturation
Timepoint
Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day after intervention
Method of measurement
According to percentage using Saadat vital sign monitoring equipment (saadat S740) made in iran

5

Description
Pulse rate
Timepoint
Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day after intervention
Method of measurement
According to number per minute using Saadat vital sign monitoring equipment (saadat S740) made in iran

6

Description
Pulse pressure
Timepoint
Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day after intervention
Method of measurement
According to mmhg using Saadat vital sign monitoring equipment (saadat S740) made in iran and insert amounts in formula: (Systolic blood pressure- Diastolic blood pressure)

7

Description
Temperature
Timepoint
Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day after intervention
Method of measurement
According to centigrade using Saadat vital sign monitoring equipment (saadat S740) made in iran

8

Description
Respiration rate
Timepoint
Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day after intervention
Method of measurement
According to number per minute using Drager ventilator model Evita2 made in Germany

9

Description
Respiratory tidal volume
Timepoint
Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day after intervention
Method of measurement
According to ml using Drager ventilator model Evita2 made in Germany

10

Description
Respiratory minute volume
Timepoint
Before intervention; immediately; 2 hour after passive movement of lower extremity; 6 hour, 12 hour, and one day after intervention
Method of measurement
According to ml using Drager ventilator model Evita2 made in Germany

Secondary outcomes

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Intervention groups

1

Description
Intervention group: Applying protocol of passive movement of lower extremity consist of raising each legs, up and down and rotational movements at the ankles, flexion and extension of each knees and hip joints in addition to receiving routine treatment and usual care
Category
Treatment - Other

2

Description
Control group:giving routine treatment and usual care, but not giving research interventions
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr. Seyed Zaker Saieedinejad
Street address
Shahid Montazeri Street, Yasuj
City
Yasuj

2

Recruitment center
Name of recruitment center
Imam Sajjad Hospital
Full name of responsible person
Dr. Farzad Vafaie
Street address
Shahid Dr.Jalil Street, Yasuj
City
Yasuj

3

Recruitment center
Name of recruitment center
Shahid Rajaie Hospital
Full name of responsible person
Dr. Hayedeh Hafez Quran
Street address
Shafa Square, Parastar Street, Gachsaran
City
Gachsaran

4

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Amir Molaie
Street address
Sepah Street, Dehdasht
City
Dehdasht

5

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Dr. Reza Jouybar
Street address
Namazi Square, Zand Street , Shiraz
City
Shiraz

6

Recruitment center
Name of recruitment center
Shahid Faghihi(Saadi) Hospital
Full name of responsible person
Dr. Peyman Petramfar
Street address
Zand Street, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chanellor for research of Yasuj University of Medical Sciences
Full name of responsible person
Dr. Seyed Abdmohammad Mousavi
Street address
Vice Chancellor for research , Yasuj University of Medical Science, Shahid Motahari Blvd.
City
Yasuj
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanellor for research of Yasuj University of Medical Sciences
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
Yasuj University of Medical Sciences
Full name of responsible person
Dr. Mohammad Zoladl
Position
PhD of psychiatric nursing ; Associate Professor
Other areas of specialty/work
Street address
Faculty of Nursing and midwifery, Shahid Dr.Jalil Street
City
Yasuj
Postal code
7591994799
Phone
+98 74 3323 5144
Fax
Email
zoladl.mohammad@yums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Shahla Najafi Dolatabad
Position
Ms of medical surgical nursing, faculty member(lecturer)
Other areas of specialty/work
Street address
Faulty of nursing and midwifery of Yasuj University of Medical Science, Shahid Dr.Jalil Street, Yasuj
City
Yasuj
Postal code
7591994799
Phone
+98 74 3323 5144
Fax
Email
shahlaiss@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Rahman Rezaeikia
Position
Ms student of medical surgical nursing
Other areas of specialty/work
Street address
Faulty of nursing and midwifery of Yasuj University of Medical Science, Shahid Dr.Jalil Street
City
Yasuj
Postal code
7591994799
Phone
+98 74 3323 5144
Fax
Email
rahman.rezaeikia@yums.ac.ir; rahman.rezaei93@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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