Effects of Position Change After PCI

NCT03611933 | Completed

• 1 other identifier: 16214662/050.01.04/85
• Study Type: interventional
• Target: 232
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Percutaneous Coronary Intervention; Coronary Artery Disease

Keywords

Back pain; patient positioning; vascular complications; vital signs

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Control group (CG)

NO INTERVENTION

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.

Experimental group (EG)

EXPERIMENTAL

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.

Other: position change applied at different times

Interventions

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°

Experimental group (EG)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Related Publications (1)

• 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.

  PMID: 30367542 RESULT

Related Links

• Pubmed

MeSH Terms

Conditions

Coronary Artery Disease; Back Pain

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Dr.

Model Details: Randomized-controlled quasi experimental study

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 2, 2018
• Study Start: July 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share