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Effects of Position Change After PCI

The Effect of Position Change on Vital Signs, Back Pain and, Vascular Complications Following Percutaneous Coronary Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03611933
Enrollment
232
Registered
2018-08-02
Start date
2014-07-31
Completion date
2014-11-30
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Percutaneous Coronary Intervention

Keywords

Back pain, patient positioning, vascular complications, vital signs

Brief 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).

Detailed 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.

Interventions

OTHERposition 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°

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Intervention model description

Randomized-controlled quasi experimental study

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Respiratory rate (respiratory rate / min.)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 Interventionphysiological parameter - rate per minute
body temperature (centigrade degree -°C)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 Interventionphysiological parameter - measured with the use of a electronic thermometer
heart rate (min. / pulse)from the first 5th minute to the 6th hour from the first 5th minute to the 6th hour after Percutaneous Coronary Interventionphysiological parameter - beats per minute
systolic and diastolic blood pressure (mmHg)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 Interventionphysiological parameter - measured with the use of a blood-pressure monitor
back painThe 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 InterventionVisual Analog Scale (VAS) for pain- score range = 0 - 10. 0 corresponds to no pain and 10 indicates worst pain imaginable.
Bleeding (present or absent)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 Interventionvascular complication:(a) dressing contaminant, (b) pressure required, (c) dressing contaminant + pressure required, and (d) blood transfusion required
hematoma (cm)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 Interventionvascular complication: 5 centimeters (cm) to greater hematoma, major hematoma; Less than 5 cm hematoma, minor hematoma
EcchymosisThe 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 Interventionvascular complication: blue-violet coloration of the skin as a result of subcutaneous tissue bleeding

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026