The Effect of Modified Supine Position on Urinary Elimination After Percutaneous Coronary Intervention

September 30, 2023 updated by: Esra Karagoz, Istanbul University - Cerrahpasa (IUC)
Urinary retention is also a frequent complication after percutaneous coronary intervention applied via the femoral artery. The inability to manage this situation effectively leads to serious complications in the long term, prolonging the length of hospital stay and increasing the cost, as well as impairing the participants's comfort. In the investigators's country, no study has been found in which the effectiveness of an appropriate and effective lying position in performing urinary drainage in the bed in order to ensure urinary emptying and to minimize possible complications in participants undergoing percutaneous coronary intervention has been found. One study states that the modified supine position is an effective intervention on the amount of urine output in participants. In another study, it was determined that different degrees of bed height and position changes would be safe and effective in reducing regional pain and vascular complications (hematoma, bleeding, thrombosis, bruising, etc.). In this context, the aim of the study is to reveal the effect of the modified supine position on providing effective urinary drainage (hourly and 24-hour urine output) and preventing possible complications (urinary retention) in participants undergoing percutaneous coronary intervention.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular diseases are an important health problem in the world and in the investigators's country, and are among the leading causes of death in adults. According to the 2017 data of the Coronary Heart Disease and Risk Factors in Turkish Adults (TEKHARF) study, it is estimated that there are approximately 3.5 million coronary heart patients in the investigators country, this number increases by 4% per year in the investigators aging population, and 210 thousand individuals die from coronary heart disease annually.

Percutaneous coronary intervention is a revascularization method used in the treatment of coronary artery disease. Complications related to vascular access sites occur in 5-7% of patients undergoing percutaneous coronary intervention. The most common coronary vascular intervention complications are; hematoma, bleeding at the vascular access site, arterial pseudoaneurysm and arteriovenous fistula development. According to the latest guidelines and literature, bed rest ranges from 6 to 24 hours, especially after percutaneous coronary intervention applied via femoral route in order to prevent bleeding-related complications.

Another complication encountered after percutaneous coronary intervention applied through the femoral artery is difficulties in urinary drainage. Having long rest periods in the supine position and being able to urinate only in the supine position, without allowing knee bending, in order to prevent complications that may develop at the application site during this period; It can cause difficulty in emptying urine, incomplete emptying of the urine from the bladder, and retention.

In our country, no study has been found in which the effectiveness of an appropriate and effective lying position in performing urinary drainage in the bed in order to ensure urinary emptying and to minimize possible complications in patients undergoing percutaneous coronary intervention has been found. One study, states that the modified supine position is an effective intervention on the amount of urine output in patients. In another study, it was determined that different degrees of bed height and position changes would be safe and effective in reducing regional pain and vascular complications (hematoma, bleeding, thrombosis, bruising, etc.). In this context, the aim of the study is to reveal the effect of the modified supine position on providing effective urinary drainage (hourly and 24-hour urine output) and preventing possible complications (urinary retention) in patients undergoing percutaneous coronary intervention.

Formation of the Experimental Group and Interventions:

Written and verbal consent will be obtained from participants who agree to participate in the study. Among the participants in the control group, for whom consent was obtained, the standard clinical procedure including supine after percutaneous coronary intervention (0 degrees flat on the back) will be provided, and for the participants in the experimental group, care including the modified supine position will be provided. The modified supine position is a position in which participants lie on their back with the head of the bed elevated at an angle of 20 degrees, with a pillow between the soles of their feet and the end of the bed. Both study groups will be required to lie supine in bed for 6 hours and stay in bed for 12 hours before ambulation is allowed in order not to increase the risk of local bleeding, as required by the clinical procedure. For this reason, these measurements determined for urinary excretion will be followed by the investigator for 6 hours. In addition, participants in the experimental and control groups will be encouraged to drink and urinate within 2 hours after percutaneous coronary intervention in order to facilitate the elimination of contrast material, and the amount of fluid ingested and excreted for 6 hours will be recorded by the investigator. The primary outcome variables of the study in determining bladder function will be time to first urgency and voiding function. participants with the feeling of urination will call the investigative nurse with the call bell and the time will be followed from the moment the slider/duck/voiding bottle is placed until the end of urination. This time will give the first urination time and will be evaluated at 4 levels. These 4 levels; Level 0: Urinating within 1 minute Level 1: Urinating within 1 to 30 minutes Level 2: Urinating within 1 to 30 minutes and needing assistance such as massage or heat pack to do so Level 3: Self or other It is stated that he cannot urinate with help methods and needs a urinary catheter. Levels 2 to 3 are considered impaired voiding. Secondary research variables are initial voiding volume and assessment of urinary retention volume. The first voiding volume will be measured, and for urinary retention, the volume of urine remaining in the bladder will be measured and recorded with a portable ultrasound device. For this measurement, the investigator nurse nurse will receive training on how to measure the volume of urine remaining in the bladder with an ultrasound device. The need for catheterization within the first 24 hours after percutaneous coronary intervention will be defined as urinary retention.

To evaluate the safety of the modified supine position, the presence/absence of complications such as back pain, deep vein thrombosis, hematoma, ecchymosis and pseudoaneurysm that may develop after percutaneous coronary intervention will be recorded. Pain; Before and immediately after the procedure, participants will be assessed by the Visual Analogue Scale (VAS) for pain at the puncture site or back. Anxiety will be measured as they are risk factors for post-intervention urinary retention. In addition, anxiety levels will be evaluated before the procedure in order to ensure conjugation in the experimental and control groups. Vascular intervention complications such as thrombosis, hematoma, ecchymosis and pseudoaneurysm will be observed for 6 hours and recorded in case of change. The dorsalis pedis pulse, foot color and temperature change will be evaluated to detect thrombosis. In addition, the bladder diary (voiding/day, nocturia/day, time between voiding-min, mean voiding volume-ml) and the amount of fluid ingested and excreted during the discharge of the participants will be given by the investigator 24 hours after the procedure by phone monitoring. The participant will provide training to the participant and his or her relatives who are primarily responsible for their care in filling out this diary.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Basaksehir Cam ve Sakura City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Diagnosed with cardiovascular disease,
  • Elective hospitalizations and transfemoral percutaneous coronary intervention,
  • Ability to urinate without problems and express the desire to urinate,
  • Able to communicate verbally,
  • Not having any disability in terms of consciousness and sensory organs (Mini Mental Score 25 and above),
  • Adult patients who volunteer to participate in the study will be included.

Exclusion Criteria:

•Participants who underwent intraoperative foley catheterization, who had a history of prostate hyperplasia, prostate carcinoma, urinary tract infection, urological disease, sensory disorders or neurological problems, who had the procedure performed under spinal or epidural anesthesia, who cannot tolerate the supine position according to the clinical procedure, and who cannot communicate in Turkish will not be included.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: İntervention Group
Modified supine position care
Other: Modified Supine Position
Among the patients in the control group, for whom consent was obtained, the standard clinical procedure including supine after percutaneous coronary intervention (0 degrees flat on the back) will be provided, and for the patients in the experimental group, care including the modified supine position will be provided. The modified supine position is a position in which patients lie on their back with the head of the bed elevated at a 20-degree angle, with a pillow between the soles of their feet and the end of the bed. Both study groups will be required to lie supine in bed for 6 hours and stay in bed for 12 hours before ambulation is allowed in order not to increase the risk of local bleeding, as required by the clinical procedure.
No Intervention: Control Group
Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time taken to reach first voiding function.
Time Frame: Measurement of the time from the moment the bedpan/duck/urine bottle was placed to the end of urination in participants who felt the urge to urinate within the first 6 hours after coronary angiography.
This time will give the first urination time and will be evaluated at 4 levels. These 4 levels; Level 0: Urinating within 1 minute, Level 1: Urinating within 1 to 30 minutes, Level 2: Urinating within 1 to 30 minutes and needing assistance such as massage or heat pack to do so, Level 3: Unable to urinate by self or other means of assistance and needs a urinary catheter. Levels 2 to 3 are considered impaired voiding.
Measurement of the time from the moment the bedpan/duck/urine bottle was placed to the end of urination in participants who felt the urge to urinate within the first 6 hours after coronary angiography.
Standardized Mini Mental State Examination (SMMSE)
Time Frame: İmmediately before percutaneous coronary intervention, baseline.
SMMSE scores of 23 and below are considered to be indicative of cognitive impairment. In this study, patients with 25 points and above will be included in the study.
İmmediately before percutaneous coronary intervention, baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
It is the evaluation of initial voiding volume and urinary retention volume.
Time Frame: Immediately after first urination.
The first voiding volume will be measured, and for urinary retention, the volume of urine remaining in the bladder will be measured and recorded with a portable ultrasound device.
Immediately after first urination.
Change in pain as measured by Visual Analog Scale.
Time Frame: İmmediately before percutaneous coronary intervention and immediately after the first voiding.
Measured using the Visual Analog Scale for pain, on a scale of 0 to 10, in which a higher score means an increased level of pain.
İmmediately before percutaneous coronary intervention and immediately after the first voiding.
Change in anxiety as measured by Visual Analog Scale (VAS-A).
Time Frame: İmmediately before percutaneous coronary intervention and immediately after the first voiding.
Measured using the Visual Analog Scale for anxiety, on a scale of 0 to 10, in which a higher score means an increased level of anxiety.
İmmediately before percutaneous coronary intervention and immediately after the first voiding.
Evaluation of the presence of thrombosis in the extremity where the femoral artery is located where percutaneous coronary intervention is performed.
Time Frame: The first 6 hours after the procedure.
The presence of thrombosis will be accepted if at least one of the following conditions is present: absence of dorsalis pedis pulse, cyanosis of the extremity, increase in extremity diameter and temperature.
The first 6 hours after the procedure.
Follow-up of post-procedure fluid intake and urine output as measured by the European Association of Urology bladder diary.
Time Frame: From the 6th hour to the 24th hour after the procedure.
The European Association of Urology bladder diary includes information about the participant's hourly fluid intake, urine output, and urination characteristics.
From the 6th hour to the 24th hour after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 9, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 30, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

September 30, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-66175679-514.99-1045359

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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