Preliminary Exploration of Factors Affecting Complete Hemostasis and Supine Time After Removal of Femoral Arterial Sheath in ICU Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Direct Inspection, medical records browsing.
- Who it may be relevant to
- Registry conditions: Removal of Femoral Arterial Sheath in ICU Patients, Complete Hemostasis, Coronary Artery Disease, Percutaneous Coronary Intervention. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Background:Following cardiac catheterization and arterial sheath removal, manual compression is applied until bleeding stops, after which a compression belt is used. Patients must lie supine for at least 6 hours, often experiencing discomfort including back pain, eating difficulties, and urinary problems. The compressed leg is restrained to prevent movement, adding to the discomfort. Despite adhering to this standard procedure, some patients still develop bleeding or hematomas after compression, requiring extended treatment. Current research on predicting compression duration and bleeding risk factors after femoral arterial sheath removal is limited and inconsistent. This study aims to identify factors that can more accurately predict necessary compression time after initial hemostasis, potentially reducing patient discomfort and complications such as prolonged bleeding, extended compression, and hematoma formation, which can impact vital signs. Purpose:To understand the factors influencing complete hemostasis and supine duration after femoral arterial sheath removal in ICU patients. Methods:Clinical data were collected through observation, and statistical analysis was performed using SPSS. Expected Outcomes:To identify factors that influence complete hemostasis and supine duration after femoral arterial sheath removal in ICU patients, and to develop a prediction model that allows clinical units to accurately assess the required supine compression time following femoral arterial sheath removal.
Interventions
- Diagnostic test Direct Inspection, medical records browsing
Inspect the puncture site directly and collect data from medical records.
Primary outcome measures
- To understand the factors influencing complete hemostasis and supine duration after femoral arterial sheath removal in ICU patients. [Time frame: This study is a correlational study, and its main objective is to identify the factors associated with the inability to achieve complete hemostasis within the standard time (defined as 6 hours).]
Eligibility criteria
Inclusion criteria
- Patients admitted to the cardiac intensive care unit of this hospital.
- Patients undergoing femoral arterial sheath removal.
- Age 20 years or older.
Exclusion criteria
- Patients unable to maintain supine position or refusing physical restraints.
- Patients with severe hematoma, vascular rupture, or other vascular complications present at the femoral arterial puncture site at the time of sheath insertion.
- Patients with a diagnosis of severe disseminated intravascular coagulation (DIC).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Publications
- Busca E, Airoldi C, Bertoncini F, Buratti G, Casarotto R, Gaboardi S, Faggiano F, Barisone M, White IR, Allara E, Dal Molin A. Bed rest duration and complications after transfemoral cardiac catheterization: a network meta-analysis. Eur J Cardiovasc Nurs. 2023 Jul 19;22(5):454-462. doi: 10.1093/eurjcn/zvac098. PMID 36256701
- Doyle BJ, Ting HH, Bell MR, Lennon RJ, Mathew V, Singh M, Holmes DR, Rihal CS. Major femoral bleeding complications after percutaneous coronary intervention: incidence, predictors, and impact on long-term survival among 17,901 patients treated at the Mayo Clinic from 1994 to 2005. JACC Cardiovasc Interv. 2008 Apr;1(2):202-9. doi: 10.1016/j.jcin.2007.12.006. PMID 19463301
- Marquis-Gravel G, Boivin-Proulx LA, Huang Z, Zelenkofske SL, Lincoff AM, Mehran R, Steg PG, Bode C, Alexander JH, Povsic TJ. Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary Intervention. J Am Heart Assoc. 2023 Jan 3;12(1):e025666. doi: 10.1161/JAHA.122.025666. Epub 2022 Dec 30. PMID 36583436
- 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
- Olson NC. Comparison of Head Elevation Protocols Following Femoral Artery Sheath Removal After Coronary Angiography. Crit Care Nurse. 2016 Jun;36(3):20-34. doi: 10.4037/ccn2016560. PMID 27252099
- Reich R, Helal L, Mantovani VM, Rabelo-Silva ER. Hemostasis after percutaneous transfemoral access: A protocol for systematic review. Medicine (Baltimore). 2020 Dec 24;99(52):e23731. doi: 10.1097/MD.0000000000023731. PMID 33350755
- Santos VB, Melo LME, Assis ARV, Moraes JB, Lopes CT, Lopes JL, Barros ALBL. Decreasing length of limb immobilisation following nonelective transfemoral percutaneous coronary intervention: A randomised clinical trial. J Clin Nurs. 2019 Sep;28(17-18):3140-3148. doi: 10.1111/jocn.14860. Epub 2019 Apr 24. PMID 30938903
- Sulzbach-Hoke LM, Ratcliffe SJ, Kimmel SE, Kolansky DM, Polomano R. Predictors of complications following sheath removal with percutaneous coronary intervention. J Cardiovasc Nurs. 2010 May-Jun;25(3):E1-8. doi: 10.1097/JCN.0b013e3181c83f4b. PMID 20357666
Identifiers
NCT: NCT07469397 · 202407183RINE