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Effects of Position Change After PCI

Primary Purpose

Percutaneous Coronary Intervention, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
position change applied at different times
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Percutaneous Coronary Intervention focused on measuring Back pain, patient positioning, vascular complications, vital signs

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group (CG)

    Experimental group (EG)

    Arm Description

    Patients in the CG were provided with routine nursing care, as practiced in the clinic, including restricted bed rest. For this purpose, patients were given supine position in which the HOB was elevated 15° for 6-10 h; the patient's leg on the of the side of intervention was kept straight.

    Patients in the EG were applied position changes between the first minute and sixth hour. During the initial six hours a supportive, thin pillow, 4 x 40 x 100 cm in size, was placed between the patient's shoulders and gluteals; this reduced the pressure on local tissues and muscle groups.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 9, 2018
    Last Updated
    October 6, 2023
    Sponsor
    Kirsehir Ahi Evran University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03611933
    Brief Title
    Effects of Position Change After PCI
    Official Title
    The Effect of Position Change on Vital Signs, Back Pain and, Vascular Complications Following Percutaneous Coronary Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kirsehir Ahi Evran University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Percutaneous Coronary Intervention, Coronary Artery Disease
    Keywords
    Back pain, patient positioning, vascular complications, vital signs

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized-controlled quasi experimental study
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    232 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group (CG)
    Arm Type
    No Intervention
    Arm Description
    Patients in the CG were provided with routine nursing care, as practiced in the clinic, including restricted bed rest. For this purpose, patients were given supine position in which the HOB was elevated 15° for 6-10 h; the patient's leg on the of the side of intervention was kept straight.
    Arm Title
    Experimental group (EG)
    Arm Type
    Experimental
    Arm Description
    Patients in the EG were applied position changes between the first minute and sixth hour. During the initial six hours a supportive, thin pillow, 4 x 40 x 100 cm in size, was placed between the patient's shoulders and gluteals; this reduced the pressure on local tissues and muscle groups.
    Intervention Type
    Other
    Intervention Name(s)
    position change applied at different times
    Intervention Description
    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 Outcome Measure Information:
    Title
    Respiratory rate (respiratory rate / min.)
    Description
    physiological parameter - rate per minute
    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
    Title
    body temperature (centigrade degree -°C)
    Description
    physiological parameter - measured with the use of a electronic thermometer
    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
    Title
    heart rate (min. / pulse)
    Description
    physiological parameter - beats per minute
    Time Frame
    from the first 5th minute to the 6th hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
    Title
    systolic and diastolic blood pressure (mmHg)
    Description
    physiological parameter - measured with the use of a blood-pressure monitor
    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
    Title
    back pain
    Description
    Visual Analog Scale (VAS) for pain- score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable".
    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
    Title
    Bleeding (present or absent)
    Description
    vascular complication:(a) dressing contaminant, (b) pressure required, (c) dressing contaminant + pressure required, and (d) blood transfusion required
    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
    Title
    hematoma (cm)
    Description
    vascular complication: 5 centimeters (cm) to greater hematoma, major hematoma; Less than 5 cm hematoma, minor hematoma
    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
    Title
    Ecchymosis
    Description
    vascular complication: blue-violet coloration of the skin as a result of subcutaneous tissue bleeding
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30367542
    Citation
    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.
    Results Reference
    result
    Links:
    URL
    http://pubmed.ncbi.nlm.nih.gov/30367542/
    Description
    Pubmed

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    Effects of Position Change After PCI

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