- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07817264
EFFECTS OF ERAS PROTOCOLS ON PATIENT OUTCOMES IN CARDIOVASCULAR SURGERY
2026년 9월 8일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
50
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Bolu, 터키 (Türkiye)
- Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Quality of Recovery-40 (QoR-40) Score
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Cardiac Surgery-Related Symptom Score
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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State-Trait Anxiety Inventory Score
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Aynur Ülkü, Karabuk Universty
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2024년 10월 30일
기본 완료 (실제)
2024년 10월 30일
연구 완료 (실제)
2025년 5월 30일
연구 등록 날짜
최초 제출
2026년 9월 8일
QC 기준을 충족하는 최초 제출
2026년 9월 8일
처음 게시됨 (실제)
2026년 9월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 8일
마지막으로 확인됨
2024년 10월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- KarabukU-AUlku-1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .