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

NCT06070545 | Unknown

• 1 other identifier: E-66175679-514.99-1045359
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Retention

Keywords

Percutaneous Coronary Intervention; Patient Positioning; Urinary Elimination

Outcome Measures

Primary Outcomes (2)

• Time taken to reach first voiding function.

  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)

  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 Outcomes (5)

• It is the evaluation of initial voiding volume and urinary retention volume.

  Immediately after first urination.

• Change in pain as measured by Visual Analog Scale.

  İmmediately before percutaneous coronary intervention and immediately after the first voiding.

• Change in anxiety as measured by Visual Analog Scale (VAS-A).

  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.

  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.

  From the 6th hour to the 24th hour after the procedure.

Study Arms (2)

İntervention Group

EXPERIMENTAL

Modified supine position care

Other: Modified Supine Position

Control Group

NO INTERVENTION

Standard Care

Interventions

Modified Supine Position OTHER

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.

İntervention Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Basaksehir Cam ve Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (11)

• Abdollahi AA, Mehranfard S, Behnampour N, Kordnejad AM. Effect of Positioning and Early Ambulation on Coronary Angiography Complications: a Randomized Clinical Trial. J Caring Sci. 2015 Jun 1;4(2):125-34. doi: 10.15171/jcs.2015.013. eCollection 2015 Jun.

  PMID: 26171374 BACKGROUND

• Açıkel S, Atar İ, Bozbaş H, Aydınalp A, Bilgi M, Yıldırır A, Özin B ve Müderrisoğlu H. TGKD Femoral bölgede hematom. 2010; 14(3):11-116.

  BACKGROUND

• Alagöl B. İdrar retansiyonu: Üroloji 3. Baskı; Ed.: Osman İnci. Ankara: Güneş Kitabevi 2006; 1-5.

  BACKGROUND

• Bakan G. Perkütan koroner girişimlerde kanıta dayalı bakım uygulamaları. Turkish Journal of Cardiovascular Nursing. June 2016; 7(sup 1):26-34.

  BACKGROUND

• Liu YS, Wei S, Elliott M. The effects of a catheter clamping protocol on bladder function in neurosurgical patients: a controlled trial. Int J Nurs Pract. 2015 Feb;21(1):29-36. doi: 10.1111/ijn.12209. Epub 2013 Nov 13.

  PMID: 24219753 BACKGROUND

• Liu Y, Zhang Y, Wu Y, Elliott M. A Modified Supine Position Facilitates Bladder Function in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Controlled Clinical Trial. J Cardiovasc Nurs. 2018 Mar/Apr;33(2):152-159. doi: 10.1097/JCN.0000000000000436.

  PMID: 28723835 BACKGROUND

• Mohammady M, Atoof F, Sari AA, Zolfaghari M. Bed rest duration after sheath removal following percutaneous coronary interventions: a systematic review and meta-analysis. J Clin Nurs. 2014 Jun;23(11-12):1476-85. doi: 10.1111/jocn.12313. Epub 2013 Sep 13.

  PMID: 24028631 BACKGROUND

• Onat A. TEKHARF 2017 Tıp dünyasının kronik hastalılarına öncülük. Erişim Adresi: https://file.tkd.org.tr/PDFs/TEKHARF-2017.pdf. Erişim Tarihi: 25.06.2022.

  BACKGROUND

• Niknam Sarabi H, Farsi Z, Butler S, Pishgooie AH. Comparison of the effectiveness of position change for patients with pain and vascular complications after transfemoral coronary angiography: a randomized clinical trial. BMC Cardiovasc Disord. 2021 Feb 25;21(1):114. doi: 10.1186/s12872-021-01922-w.

  PMID: 33632127 BACKGROUND

• Türk kardiyoloji derneği girişimsel kardiyolojide yetkinlik kılavuzu. Erişim Adresi: https://tkd.org.tr/kilavuz/girisimsel_kilavuz.htm. Erişim Tarihi: 26.06.2022.

  BACKGROUND

• Uslu Y ve Yavuz M. Ameliyat sonrası üriner retansiyon ve yönetimi. Yeni Üroloji Dergisi - The New Journal of Urology. 2016; 11(1):48-53.

  BACKGROUND

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Esra Karagöz

CONTACT

05321722279; esragundogdu_88@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: October 6, 2023
• Study Start: October 9, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)