Coronary Artery Disease Clinical Trial
Official title:
The Effect of Position Change on Vital Signs, Back Pain and, Vascular Complications Following Percutaneous Coronary Intervention
Verified date | March 2024 |
Source | Kocaeli University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aims and objectives: To determine the effect of position change that is applied after percutaneous coronary intervention on vital signs, back pain, and vascular complications. Background: In order to minimize the post-procedure complications, patients are restricted to prolonged bed rest that is always accompanied by back pain and and hemodynamic instability. Design: Randomized-controlled quasi experimental study Methods: The study sample chosen for this study included 200 patients who visited a hospital in Turkey between July 2014 and November 2014. Patients were divided into two groups by randomization. Patients in the control group (CG, n = 100) were put in a supine position, in which the head of the bed (HOB) was elevated to 15°, the patient's leg on the side of the intervention was kept straight and immobile; positional change was applied to patients in the experimental group (EG, n = 100).
Status | Completed |
Enrollment | 232 |
Est. completion date | November 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 18-80 years of age - a 6-7 F catheter - must be able to lie in a supine position (without breathing problems) - must be in balance hemodynamically Exclusion Criteria: - hypotension - hyperthermia or hypothermia - no procedure except for PCI - coagulation disorder - decompensated heart failure - diastolic blood pressure (DBP) > 100 mmHg - systolic blood pressure (SBP) > 180 mmHg - vascular complications - the femoral artery damage - body mass index = 35 kg/m2 - pre-treatment back pain - vertebral disc disease |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Kocaeli University |
Mert Boga S, Oztekin SD. The effect of position change on vital signs, back pain and vascular complications following percutaneous coronary intervention. J Clin Nurs. 2019 Apr;28(7-8):1135-1147. doi: 10.1111/jocn.14704. Epub 2018 Nov 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Respiratory rate (respiratory rate / min.) | physiological parameter - rate per minute | The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention | |
Primary | body temperature (centigrade degree -°C) | physiological parameter - measured with the use of a electronic thermometer | The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention | |
Primary | heart rate (min. / pulse) | physiological parameter - beats per minute | from the first 5th minute to the 6th hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention | |
Primary | systolic and diastolic blood pressure (mmHg) | physiological parameter - measured with the use of a blood-pressure monitor | The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention | |
Primary | back pain | Visual Analog Scale (VAS) for pain- score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable". | The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention | |
Primary | Bleeding (present or absent) | vascular complication:(a) dressing contaminant, (b) pressure required, (c) dressing contaminant + pressure required, and (d) blood transfusion required | The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention | |
Primary | hematoma (cm) | vascular complication: 5 centimeters (cm) to greater hematoma, major hematoma; Less than 5 cm hematoma, minor hematoma | The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention | |
Primary | Ecchymosis | vascular complication: blue-violet coloration of the skin as a result of subcutaneous tissue bleeding | The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention |
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