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Completed

NCT Number: NCT03611933

Effects of Position Change After PCI

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

position change applied at different times

Other

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°

Primary outcomes

  1. Respiratory rate (respiratory rate / min.)

    Time frame: 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

    physiological parameter - rate per minute

  2. body temperature (centigrade degree -°C)

    Time frame: 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

    physiological parameter - measured with the use of a electronic thermometer

  3. heart rate (min. / pulse)

    Time frame: from the first 5th minute to the 6th hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention

    physiological parameter - beats per minute

  4. systolic and diastolic blood pressure (mmHg)

    Time frame: 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

    physiological parameter - measured with the use of a blood-pressure monitor

  5. back pain

    Time frame: 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

    Visual Analog Scale (VAS) for pain- score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable".

  6. Bleeding (present or absent)

    Time frame: 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

    vascular complication:(a) dressing contaminant, (b) pressure required, (c) dressing contaminant + pressure required, and (d) blood transfusion required

  7. hematoma (cm)

    Time frame: 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

    vascular complication: 5 centimeters (cm) to greater hematoma, major hematoma; Less than 5 cm hematoma, minor hematoma

  8. Ecchymosis

    Time frame: 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

    vascular complication: blue-violet coloration of the skin as a result of subcutaneous tissue bleeding

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 2, 2018
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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