EFFECTS OF ERAS PROTOCOLS ON PATIENT OUTCOMES IN CARDIOVASCULAR SURGERY
8 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Bolu, Turquía (Türkiye)
- Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of Recovery-40 (QoR-40) Score
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cardiac Surgery-Related Symptom Score
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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State-Trait Anxiety Inventory Score
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Aynur Ülkü, Karabuk Universty
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
30 de octubre de 2024
Finalización primaria (Actual)
30 de octubre de 2024
Finalización del estudio (Actual)
30 de mayo de 2025
Fechas de registro del estudio
Enviado por primera vez
8 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de septiembre de 2026
Publicado por primera vez (Actual)
14 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de septiembre de 2026
Última verificación
1 de octubre de 2024
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Desordenes mentales
- Complicaciones Postoperatorias
- Procesos Patológicos
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor Postoperatorio
- Desórdenes de ansiedad
- Calidad, acceso y evaluación de la atención médica
- Terapéutica
- Procedimientos quirúrgicos, operativo
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Características del estudio epidemiológico
- Atención perioperatoria
- Recuperación mejorada después de la cirugía
- Protocolos clínicos
Otros números de identificación del estudio
- KarabukU-AUlku-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .