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NCT Number: NCT07062432

Continuous Comprehensive Nursing for Post-CABG Recovery

This study evaluates the effectiveness of a continuous comprehensive nursing (CCN) system compared to routine care for patients after coronary artery bypass graft (CABG) surgery. The primary goal is to determine if the CCN system improves postoperative hemoglobin levels. The study also investigates the effects on quality of life, mental health (anxiety and depression), red blood cell indices, immune markers, and patient satisfaction.

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Key information

Conditions

Coronary Heart Disease (CHD) Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

About this study

Coronary artery bypass surgery (CABG) is a major procedure, and the postoperative recovery process is complex, often impacting patients' hemoglobin levels and quality of life. Standard nursing care is often limited to the inpatient period. A continuous comprehensive nursing (CCN) system is a holistic, patient-centered model that extends care beyond hospital discharge. This model includes preoperative education, continuous monitoring, personalized care plans, psychological support, rehabilitation guidance, and structured follow-up. While the benefits of comprehensive nursing are recognized, its specific impact on hemoglobin recovery and quality of life after CABG has not been extensively studied. This randomized controlled trial was designed to compare the outcomes of patients receiving a CCN plan with those receiving routine postoperative care to provide evidence for optimizing post-CABG nursing strategies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 70 years.
  • Confirmed diagnosis of coronary heart disease and evidence of coronary artery illness requiring CABG.
  • Ability to understand the purpose and procedures of the study.
  • Willingness to sign the informed consent form.

Exclusion criteria

  • Presence of serious complications such as unstable myocardial ischemia or significant arrhythmia.
  • Severe lung diseases (e.g., chronic obstructive pulmonary disease GOLD stage III/IV).
  • Severe kidney diseases (e.g., chronic kidney disease Stage 4/5).
  • Significantly impaired left ventricular ejection fraction (EF < 30%).
  • Concurrent participation in other clinical trials or receiving other interventions.
  • Presence of severe mental illnesses or cognitive impairments.

Treatment and study plan

Continuous Comprehensive Nursing System

Behavioral

A multi-faceted nursing plan delivered by trained cardiac nurses, extending from the preoperative phase to 3 months post-discharge. In addition to routine inpatient care, the intervention included: preoperative education and psychological support; postoperative individualized rehabilitation guidance; and a continuous post-discharge program. The post-discharge phase involved structured follow-up (monthly phone calls, one 6-week outpatient visit), ongoing psychological support, reinforcement of education on medication adherence, diet, and activity progression, and guidance on a structured home-based exercise program.

Routine Postoperative Care

Other

Standard institutional postoperative care for patients after Coronary Artery Bypass Graft (CABG) surgery. This care was primarily focused on the inpatient period and included monitoring of vital signs, wound and drainage tube management, respiratory and circulatory support, and progressive diet guidance. The care concluded with standard discharge instructions and did not include the structured, continuous, or extended follow-up provided to the intervention group.

Primary outcomes

  1. Change in Hemoglobin (Hb) Levels from Baseline to Day 7 Post-Surgery

    Time frame: Baseline (preoperatively) and Day 7 post-surgery.

    The change in hemoglobin concentration (g/L) was measured from the preoperative baseline value to the value at 7 days after the surgery. Venous blood samples were analyzed using an automatic biochemical analyzer.

Secondary outcomes

  1. Change in Hemoglobin (Hb) Levels at Other Time Points

    Time frame: Baseline, 12 hours, 72 hours, and 14 days post-surgery.

    Hemoglobin concentration (g/L) measured at multiple time points to assess the recovery trajectory.

  2. Red Blood Cell Indices

    Time frame: Day 7 post-surgery.

    Measurement of Mean Corpuscular Volume (MCV, in fL), Red Blood Cell Distribution Width (RDW, in %), and Hematocrit (HCT, in %).

  3. Levels of Immune-Related Inflammatory Markers

    Time frame: Day 7 post-surgery.

    Levels of Interleukin-2 (IL-2, in pg/mL) and Interleukin-6 (IL-6, in pg/mL) in peripheral blood, quantified using an ELISA kit.

  4. Quality of Life (QoL)

    Time frame: Day 14 post-surgery.

    Assessed using the World Health Organization Quality of Life BREF (WHOQOL-BREF) scale. This scale evaluates four domains: physical health, psychological health, social relationships, and environment. Higher scores indicate better quality of life.

  5. Depressive Symptoms

    Time frame: Day 14 post-surgery.

    Assessed using the Center for Epidemiologic Studies Depression Scale (CES-D). The scale ranges from 0 to 60, with higher scores indicating more severe depressive symptoms.

  6. Anxiety Symptoms

    Time frame: Day 14 post-surgery.

    Assessed using the Self-Rating Anxiety Scale (SAS). The scale ranges from 20 to 80, with higher scores reflecting more severe anxiety symptoms.

  7. Patient Satisfaction

    Time frame: Up to 14 days post-surgery (at time of hospital discharge).

    Assessed using a study-specific satisfaction questionnaire. Responses were categorized as "very satisfied," "satisfied," "average," or "dissatisfied" based on a scoring system from 1-100.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

Evaluating the Efficacy of a Continuous Comprehensive Nursing System on Postoperative Hemoglobin Levels and Quality of Life in Patients Undergoing Coronary Artery Bypass Surgery

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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