Development of a Nursing Care Protocol for the Prevention of Deep Vein Thrombosis and Its Impact on Patient Outcomes Following Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- The primary endpoint is the incidence of symptomatic or confirmed deep-vein thrombosis (DVT) and/or pulmonary embolism (PE) within the 3-month follow-up period. Secondary endpoints include: adherence to the prophylaxis protocol, occurrence of prophylaxis
研究概览
简要总结
The primary focus of this research proposal is to examine the efficacy of a nursing care protocol in preventing the occurrence of deep vein thrombosis (DVT) in patients undergoing on-pump cardiac surgery. The investigation will encompass an experimental group that will be subjected to a specific intervention, alongside a control group that will adhere to conventional care procedures. The central objective is to exhibit a statistically significant decrease in the incidence of DVT within the experimental group in comparison to the control group. The secondary outcomes involve assessing the severity of DVT instances and the development of associated complications.
The proposed research strategy entails delineating the criteria for selecting participants, outlining methodologies for gathering data, and detailing statistical approaches for analysis. The amassed data will undergo scrutiny through suitable statistical examinations, including chi-square tests, t-tests, or Mann-Whitney U tests, as well as logistic regression analysis. The process of data analysis will involve descriptive statistics, comparative assessments, regression analysis, and subgroup scrutiny. The interpretation of outcomes will be contextualized within the framework of the research objectives and pre-existing scientific knowledge.
The ultimate objective of this study is to enhance the existing understanding of DVT prevention, provide clinically grounded recommendations supported by evidence, and elevate the quality and safety of patient care.
详细描述
General Information Regarding the Thesis Topic Deep vein thrombosis (DVT) stands as a frequent complication encountered among patients undergoing on-pump cardiac surgery. A variety of interventions and protocols have been explored to forestall DVT, encompassing strategies like pharmacological prophylaxis, intermittent pneumatic leg compression, active toe movement, and supplementary measures. The objective of this survey of recent literature is to present the most current research related to nursing care protocols' impact on DVT prevention within the context of on-pump cardiac surgery patients.
Kakkos et al. (2022) undertook a thorough systematic examination, culminating in the determination that the combined utilization of intermittent pneumatic leg compression and pharmacological prophylaxis constitutes an efficacious approach for averting venous thromboembolism, encompassing DVT. Their conclusions resoundingly advocate for the integration of this dual strategy into a nursing care protocol to forestall DVT in on-pump cardiac surgery patients.
Abruzzo, Gorantla, and Thomas (2022) undertook a distinct systematic review with a focus on venous thromboembolic events in adults undergoing extracorporeal membrane oxygenation (ECMO) support. While the review did not exclusively center on on-pump cardiac surgery patients, it does offer valuable insights for managing individuals undergoing cardiac procedures. The review underlines the significance of acknowledging thromboembolic events in patients relying on ECMO support, and it underscores the importance of enacting appropriate prophylactic strategies to stave off DVT.
An, Phan, Levy, and Bruce (2016) conducted a systematic review and meta-analysis specifically focusing on hip and knee arthroplasty. Despite the different study population, their findings regarding the use of aspirin as thromboprophylaxis may have implications for on-pump cardiac surgery patients. The review emphasizes the potential of aspirin as a pharmacological intervention for preventing DVT.
In a prospective randomized study, Hickey et al. (2017) investigated the impact of active toe movement (AToM) on both calf pump function and the occurrence of DVT in patients with acute foot and ankle trauma who were treated with a cast. Although the study did not specifically target individuals undergoing on-pump cardiac surgery, it illuminates the potential advantages of integrating AToM into nursing care strategies to enhance venous return and thwart DVT. The outcomes suggest that incorporating AToM into nursing care protocols for on-pump cardiac surgery patients could hold promising benefits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Patients will be eligible for participation in the study if they meet all of the following criteria:
- •Adult patients aged 18 years or older.
- •Patients scheduled to undergo elective or urgent on-pump cardiac surgery using cardiopulmonary bypass (e.g., coronary artery bypass grafting, valve replacement or repair, or combined procedures).
- •Both male and female patients.
- •Patients admitted to the participating cardiac surgery unit during the study period.
- •Patients with no evidence of preoperative deep vein thrombosis (DVT) or pulmonary embolism (PE) as confirmed by clinical assessment and/or Doppler ultrasonography when indicated.
- •Patients who are hemodynamically stable postoperatively and eligible to receive mechanical and/or pharmacological thromboprophylaxis.
- •Patients able to understand the study procedures and provide written informed consent (or consent obtained from a legal representative when applicable).
- •Patients expected to survive for at least three months postoperatively, allowing completion of the follow-up period.
排除标准
- •Exclusion Criteria
- •Patients will be excluded from the study if they meet any of the following criteria:
- •History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the previous six months.
- •Known congenital or acquired coagulation disorders, including but not limited to hemophilia, thrombophilia, or antiphospholipid syndrome.
- •Patients receiving long-term therapeutic anticoagulation (e.g., warfarin, direct oral anticoagulants) for other medical indications prior to surgery.
- •Contraindications to pharmacological thromboprophylaxis, such as:
- •Active bleeding
- •Severe thrombocytopenia (platelet count <50,000/µL)
- •History of heparin-induced thrombocytopenia (HIT)
- •Contraindications to mechanical prophylaxis, including:
- •Severe peripheral arterial disease
- •Skin ulcers, infections, or recent lower-limb surgery preventing device application
- •Patients undergoing off-pump cardiac surgery or minimally invasive cardiac procedures not requiring cardiopulmonary bypass.
- •Emergency surgery requiring immediate intervention where preoperative assessment and consent cannot be obtained.
- •Pregnant or postpartum women.
- •Patients with severe renal or hepatic failure that may interfere with anticoagulant metabolism or increase bleeding risk.
- •Patients with documented malignancy under active treatment associated with a markedly elevated thrombotic risk.
- •Patients unwilling or unable to comply with the study protocol or follow-up schedule.
研究组 & 干预措施
Nursing Care Protocol The nursing care protocol designed for this study is a structured, evidence-ba
Nursing Care Protocol The nursing care protocol designed for this study is a structured, evidence-based guideline specifically tailored for on-pump cardiac surgery patients. It differs from existing DVT prevention protocols by integrating four core components: individualized risk stratification (using Padua and Caprini scores), combined pharmacological and mechanical prophylaxis, an early mobilization regimen adapted to post-cardiac surgery tolerance, and a structured patient education component. Unlike generic thromboprophylaxis guidelines, this protocol standardizes nursing-led interventions and monitoring across preoperative, intraoperative, and postoperative stages.
Follow-Up Schedule and Time-Points
Follow-Up Time-Points:
- Day 0 (Start of prophylaxis / Baseline)
- Day 3 (Early in-hospital monitoring)
- Day 7 (or just before discharge)
- Week 2 (Outpatient follow-up)
- Month 3 (Long-term follow-up)
干预措施: IPC devices facilitate venous return by simulating the physiological effects of muscle contraction, reducing venous stasis. (Device)
结局指标
主要结局
The primary endpoint is the incidence of symptomatic or confirmed deep-vein thrombosis (DVT) and/or pulmonary embolism (PE) within the 3-month follow-up period. Secondary endpoints include: adherence to the prophylaxis protocol, occurrence of prophylaxis
时间窗: 3 MUNTHS
次要结局
未报告次要终点
研究者
Abdallah Ibraheem Abdallah Halahla
Development of a Nursing Care Protocol for the Prevention of Deep Vein Thrombosis and Its Impact on Patient Outcomes Following Cardiac Surgery
Near East University, Turkey