Protocol summary

Study aim
The aim of this study was to determine the effect of nursing interventions based on the results of Wells comparisons on the incidence of deep vein thrombosis in patients admitted to the intensive care unit. According to previous studies in Iran and the world, the assessment of the risk of patients at risk for deep vein thrombosis is based on a doctor's own judgment and experience, which puts these patients at risk of developing pulmonary embolism that could expose the lives of patients. It also increases the length of hospitalization and patient costs.
Design
In this study, 72 patients admitted to the intensive care unit with a study entry age range of 18 to 65 years of age with no prostate thrombosis and pulmonary embolism are selected. Participants were randomly assigned to two groups of intervention (36) and control group (36).
Settings and conduct
This study is a non-blind clinical trial without placebo, in which patients with a minimum of 10 days admission to the intensive care unit will be selected.
Participants/Inclusion and exclusion criteria
Patients aged between 18 and 65 years with no prostate thrombosis and pulmonary embolism will be excluded and will be excluded if they fail to cooperate or die.
Intervention groups
After entering the study, patients will be divided into two non-hazardous (less than 1) and at risk levels (grade 2 and more), deep vein thrombosis, and will be studied for 10 days, based on the Wells scoring scale. Took In the intervention group, according to the Wells scale risk assessment, in the non-risk group, nursing interventions such as exercise (flexion and dorsal flexion of the lower extremity), respiratory exercises, effective cough, and maintaining the lower extremity above the heart level will be performed. In the at-risk group, in addition to the nursing interventions mentioned, the mechanical preventive measures (anti-embolism socks) and drug prevention (anaxaparin based on the prescribing dose of the physician) will be used. In the control group, patients will receive routine care according to the physician's instructions. Then, both interventional and control groups for the detection of deep vein thrombosis in the first, fifth and tenth days will be examined by the D-dimer test and Doppler sonography.
Main outcome variables
Patient evaluation can be beneficial by using a clinical predictive scale (Wells scale) for rapid identification of patients; Early identification of at-risk patients and nursing care can reduce mortality, hospitalization time, and patient costs.

General information

Reason for update
Acronym
DVT
IRCT registration information
IRCT registration number: IRCT20170624034723N1
Registration date: 2018-01-05, 1396/10/15
Registration timing: retrospective

Last update: 2018-01-05, 1396/10/15
Update count: 0
Registration date
2018-01-05, 1396/10/15
Registrant information
Name
Morteza Habibi Moghadam
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 4232 1360
Email address
moghadam.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences and health Services
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nursing interventions based on Wells scale results on the incidence of deep vein thrombosis in patients admitted to the intensive care unit
Public title
The effect of nursing interventions based on Wells scale results in the incidence of deep vein thrombosis
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
The age range is 18 to 65 years Patients with a minimum shelf-life of 10 days in Intensive Unit
Exclusion criteria:
Deep Vein Thrombosis or pulmonary embolism. take drugs that lead to blood coagulation, such as Tranexamic Acid. chronic disease that affects the treatment process, such as severe vascular disease, kidney failure. having chronic alcohol consumption history Pregnancy. In the event of any hemodynamic disorder (such as severe rhythm instability, septic shock and instability in blood pressure). Patients with coronary artery disease in the acute phase. Detect an imminent death by a doctor. Failure to co-operate with the patient or his supervisor.
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
Participants were randomly assigned and randomly divided into two intervention groups (36) and a control group (36) using a randomized design designed by a statistic consultant.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ethics Committee, Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15749
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
IR.AJUMS.REC.1396.378

Health conditions studied

1

Description of health condition studied
Deep Vein Thrombosis
ICD-10 code
I82
ICD-10 code description
Formation of thrombosis in the deep veins

Primary outcomes

1

Description
Incidence of deep vein thrombosis
Timepoint
Days 1, 5, 10
Method of measurement
Wells scale, d-dimer, Doppler ultrasound

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, patients who are on a Wells scale fall into an unprotected group. Nursing interventions include exercise (flexion and dorsiliation of the lower limb flexion), respiratory exercises, effective cough, and maintaining lower limbs above the cardiac level. Patients who are considered to be at high risk of developing deep vein thrombosis based on the Wells scale, in addition to nursing interventions, will use mechanical preventive measures (anti-embolic socks) and drug prevention (Enoxaparin Sodium based on the prescribing dose of the physician).
Category
Prevention

2

Description
In the control group (n = 36) after the classification of patients according to Wells scale to two levels of no-risk (18 cases) and at high risk (18 cases), deep vein thrombosis involved patients with routine care interventions including: exercise ( Respiratory exercises, effective cough, and lower extremity maintenance are higher than the heart rate, according to the instructions of the respective physician.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Gonjavian Hospital
Full name of responsible person
Morteza Habibi Moghadam
Street address
Andimeshk Dezful Road, Dezful
City
Dezful
Province
Khouzestan
Postal code
64619-16118
Phone
+98 61 4232 1360
Email
habibi.morteza94@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Behzad Makmalzadeh
Street address
Golestan st, Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15749
Phone
+98 61 4232 1360
Email
habibi.morteza94@gmail.com
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, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Morteza Habibi Moghadam
Position
Master of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Golestan st, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15749
Phone
+98 61 3373 8396
Fax
Email
habibi.morteza94@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Marzieh Asadizaker
Position
Phd of Nursing, Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan st, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15749
Phone
+98 61 3373 8396
Fax
Email
marziyehasadizaker@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Morteza Habibi moghadam
Position
Master of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Golestan st, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
61619-16118
Phone
+98 61 4232 1360
Fax
Email
habibi.morteza94@gmail.com
Web page address

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
Loading...