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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
50
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Bolu、トルコ（Türkiye）
- Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
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.
|
|
介入なし：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of Recovery-40 (QoR-40) Score
時間枠：one month
|
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
|
one month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cardiac Surgery-Related Symptom Score
時間枠：one month
|
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.
|
one month
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
State-Trait Anxiety Inventory Score
時間枠：1 month
|
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.
|
1 month
|
|
Postoperative Delirium
時間枠：One month
|
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
|
One month
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Aynur Ülkü、Karabuk Universty
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年10月30日
一次修了 (実際)
2024年10月30日
研究の完了 (実際)
2025年5月30日
試験登録日
最初に提出
2026年9月8日
QC基準を満たした最初の提出物
2026年9月8日
最初の投稿 (実際)
2026年9月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月14日
QC基準を満たした最後の更新が送信されました
2026年9月8日
最終確認日
2024年10月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- KarabukU-AUlku-1
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。