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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03611933
Other study ID # 16214662/050.01.04/85
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2014
Est. completion date November 2014

Study information

Verified date July 2018
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

Percutaneous coronary intervention (PCI) is an interventional procedure used to diagnose and treat chronic coronary artery disease. The recommended period of bed rest following a PCI is reported by Rolley et al. (2011) as being 2-4 hours (h). According to evidence-based guidelines in relevant literature, however, the bed rest was reported from 2-24 h; in these instances the supine position (SP) was used, which leads to movement limitation.

Among the patient-care goals during the post-procedural period, sustaining tissue perfusion and heart and vascular system operation, regulating vital signs, reducing pain, and supporting movement are important. According to such a procedure, the nurse's independent role is to provide the safest position for the patient, thereby positively affecting vital signs after PCI and reducing vascular complications and back pain.

Recently, similar nursing studies have reported the effect of position change after PCI on back pain, as well as vascular complications after PCI, the effect of position change on certain vital signs and vascular complications, the effect of position change regarding pain, patient comfort and certain vital signs, and the effect of positional change on intervention pain and all vital signs. Some studies have also looked into the effect of positional changes on back pain, certain vital signs, and vascular complication.

Prolonged bed rest in a SP has become tradition, but it can have negative effects. Comprehensive studies in the existing literature that can be applied to the post-PCI nursing care process—and which study the effect of the most reliable positional change on all vital signs, vascular complications, and, back pain—display a numerical inadequacy. Consequently, the authors intend the current study to be an experimental investigation of the effect of position change on vital signs, vascular complications, and back pain.


Recruitment information / eligibility

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 and older
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

Study Design


Intervention

Other:
position change applied at different times
Time 1 - in the first fifth minute after the procedure supine position in which the HOB was elevated 15° Time 2 - in the first hour low fowler's position were given in which the HOB was elevated 15-30° Time 3 - in the third hour semi high fowler's position were given in which the HOB was elevated 30-45° Time 4 - in the fourth hour left or right lateral position were given in which the HOB was elevated 15° Time 5 - in the fifth hour low fowler's position were given in which the HOB was elevated 15-30° Time 6 - in the sixth hour standard fowler's position were given in which the HOB was elevated 45-60°

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli University

Outcome

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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