EFFECTS OF ERAS PROTOCOLS ON PATIENT OUTCOMES IN CARDIOVASCULAR SURGERY
2026年9月8日 更新者：Aynur Ülkü、Karabuk University
THE EFFECTS OF ERAS PROTOCOLS ON PATIENT OUTCOMES IN CARDIOVASCULAR SURGERY
A randomized controlled experimental study has been conducted to determine the effects of Enhanced Recovery After Surgery (ERAS) protocols on patient outcomes in the Cardiovascular Surgery Clinic.
研究概览
详细说明
This randomized controlled trial was conducted to evaluate the effects of an Enhanced Recovery After Surgery (ERAS) protocol on postoperative recovery and patient outcomes in patients undergoing elective coronary artery bypass grafting (CABG) surgery.
The study was conducted in the Cardiovascular Surgery Clinic of Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital.
A total of 50 patients who met the eligibility criteria were included in the study and randomly assigned to either the ERAS group (n=25) or the control group (n=25).
Patients in the ERAS group received a comprehensive perioperative care program based on ERAS principles.
The ERAS program included preoperative oral carbohydrate loading, multimodal analgesia, prevention of postoperative nausea and vomiting, early extubation, respiratory exercises, coughing exercises, early mobilization, and other evidence-based perioperative interventions.
Patients in the control group received routine perioperative care according to standard clinical practice.
The primary outcomes included quality of recovery and postoperative clinical outcomes.
Quality of recovery was assessed using the Quality of Recovery-40 (QoR-40) questionnaire.
Secondary outcomes included anxiety, pain intensity, nutritional risk, postoperative delirium, and cardiovascular surgery-related symptoms.
Clinical recovery outcomes included time to extubation, duration of intensive care unit stay, duration of surgical drain use, time to urinary catheter removal, time to first bowel movement, time to first oral intake, and length of hospital stay.
Patients were evaluated at multiple time points throughout the postoperative recovery process.
Assessments were performed during the intensive care unit stay, after transfer to the surgical ward, at hospital discharge, and at one week and one month after discharge.
These repeated assessments were used to evaluate changes in quality of recovery, anxiety, pain, cardiovascular surgery-related symptoms, and other patient outcomes over time.
The study aimed to determine whether implementation of a comprehensive ERAS protocol could improve quality of recovery, reduce postoperative symptoms and anxiety, facilitate earlier recovery, shorten intensive care unit and hospital stays, and contribute to improved clinical outcomes in patients undergoing cardiovascular surgery.
研究类型
介入性
注册 (实际的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Bolu、土耳其（türkiye）
- Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Being admitted for their first planned coronary artery bypass graft (CABG) surgery;
- Undergoing off-pump coronary artery bypass (OPCAB) surgery without the use of a cardiopulmonary bypass machine;
- Not undergoing any additional surgical procedure during CABG surgery;
- Having no abnormalities in preoperative laboratory parameters, including hemoglobin, albumin, and electrolytes;
- Having no cognitive impairment;
- Having no psychological or mental disorder;
- Being able to speak Turkish and communicate effectively;
- Being at least literate;
- Being 18 years of age or older;
- Being reachable by telephone during the follow-up period; and
- Providing informed consent to participate in the study.
Exclusion Criteria:
- Having previously undergone CABG surgery;
- Undergoing CABG surgery using cardiopulmonary bypass with the heart arrested;
- Undergoing any additional surgical procedure during CABG surgery;
- Having electrolyte abnormalities in preoperative laboratory parameters;
- Having cognitive impairment;
- Having a psychological or mental disorder;
- Being unable to speak Turkish, communicate effectively, or provide consent to participate in the study;
- Being unable to read and write;
- Being younger than 18 years of age;
- Being unreachable by telephone during the follow-up period;
- Withdrawing from the study after initially agreeing to participate;
- Undergoing any surgical operation after hospital admission; or
- Dying during the study intervention or follow-up period.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：ENHANCED RECOVERY AFTER SURGERY (ERAS) GROUP
Patients in the ERAS group received a multimodal enhanced recovery program covering the preoperative, intraoperative, and postoperative periods.
Interventions included patient education and counseling, nutritional assessment and support when indicated, preoperative oral carbohydrate loading, appropriate fasting, and avoidance of mechanical bowel preparation.
Intraoperative interventions included multimodal anesthesia, lung-protective ventilation, maintenance of normothermia, antimicrobial prophylaxis, blood conservation, and minimization of surgical drains.
Postoperative care included early extubation, respiratory physiotherapy, incentive spirometry, coughing and leg exercises, early mobilization and oral intake, multimodal analgesia, thromboprophylaxis, glycemic control, wound care, delirium screening, and early removal of chest tubes and urinary catheters when clinically appropriate.
Quality of recovery, anxiety, pain, and cardiovascular surgery-related symptoms were assessed during
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A comprehensive 31-factor Enhanced Recovery After Surgery (ERAS) program was implemented throughout the perioperative period in patients undergoing elective coronary artery bypass grafting (CABG) surgery.
The program included patient education and counseling, nutritional assessment, preoperative oral carbohydrate loading, appropriate fasting, avoidance of mechanical bowel preparation, multimodal anesthesia and analgesia, lung-protective ventilation, normothermia, antimicrobial prophylaxis, blood conservation, prevention of postoperative nausea and vomiting, early extubation, respiratory physiotherapy, incentive spirometry, coughing and leg exercises, early mobilization and oral intake, thromboprophylaxis, glycemic control, systematic delirium screening, wound care, and early removal of chest tubes and urinary catheters when clinically appropriate.
Quality of recovery, anxiety, pain, and cardiovascular surgery-related symptoms were assessed at predefined postoperative time points.
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无干预：CONTROL GROUP
Patients in the control group received routine perioperative care according to standard clinical practice.
No specific Enhanced Recovery After Surgery (ERAS) protocol was applied.
Patients received standard preoperative, intraoperative, and postoperative care, including routine monitoring, pain management, respiratory care, mobilization, nutritional management, and other clinical interventions as indicated by the treating healthcare team.
Patient outcomes were assessed at the same time points as in the ERAS group.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of Recovery-40 (QoR-40) Score
大体时间：one month
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The scale is a 5-point Likert-type scale, and the total score ranges from 40 to 200 based on the sum of all items.
A higher total score indicates that the patients' emotional and physical well-being is at the expected and favorable level following surgery, whereas a lower score indicates that their well-being has been adversely affected.
With a Cronbach's alpha value of 0.936, the questionnaire is a valid and reliable instrument for assessing recovery following
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one month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cardiac Surgery-Related Symptom Score
大体时间：one month
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The inventory is unidimensional and consists of 35 items.
It is a Likert-type instrument, with each item scored from 0 to 4. The total score ranges from 0 to 140, with higher scores indicating greater symptom severity.
The inventory has a total Cronbach's alpha coefficient of 0.961, and the total item correlations for all items are positive.
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one month
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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State-Trait Anxiety Inventory Score
大体时间：1 month
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The State-Trait Anxiety Inventory (STAI) was developed to assess individuals' state and trait anxiety levels separately.
The scale consists of two sections and 40 items.
The first section, the State Anxiety Inventory, assesses how the individual feels at a particular moment, whereas the second section, the Trait Anxiety Inventory, assesses the individual's general feelings and anxiety tendency.
Higher total anxiety scores indicate higher levels of anxiety.
The scale has a Cronbach's alpha coefficient of 0.76.
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1 month
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Postoperative Delirium
大体时间：One month
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The scale assesses eight domains: attention deficit, altered level of consciousness, hallucinations, psychosis, delusions, disorientation, psychomotor retardation or agitation, inappropriate affect or speech, sleep-wake cycle disturbance, and fluctuating course of symptoms.
Negative findings are scored as 0, while positive findings are scored as 1.
Patients with a total score of 4 or higher are considered to have delirium
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One month
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Aynur Ülkü、Karabuk Universty
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年10月30日
初级完成 (实际的)
2024年10月30日
研究完成 (实际的)
2025年5月30日
研究注册日期
首次提交
2026年9月8日
首先提交符合 QC 标准的
2026年9月8日
首次发布 (实际的)
2026年9月14日
研究记录更新
最后更新发布 (实际的)
2026年9月14日
上次提交的符合 QC 标准的更新
2026年9月8日
最后验证
2024年10月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- KarabukU-AUlku-1
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant-level data will not be shared publicly due to patient privacy and confidentiality requirements.
However, the aggregated results of the study will be reported and made available through scientific publication.
No personally identifiable patient information will be included in the published results.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.