Continuous Comprehensive Nursing for Post-CABG Recovery

July 10, 2025 updated by: Beibei Xing, The First Hospital of Hebei Medical University

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

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The First Hospital of Hebei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous Comprehensive Nursing (CCN) System

Participants received a continuous comprehensive care plan delivered by specifically trained cardiac nurses. This plan included:

  • Preoperative Phase: Comprehensive education about the surgery, risks, and expected outcomes, along with psychological support.
  • Intraoperative Phase: Standard intraoperative nursing care including close monitoring.
  • Postoperative Inpatient Phase: In addition to routine care, this phase focused on pain management, wound care, and individualized rehabilitation guidance.
  • Post-Discharge Continuous Phase (3 months): This phase included regular follow-up (monthly phone calls, one outpatient visit at 6 weeks), ongoing psychological support, continuous education (medication adherence, diet, activity), structured home-based rehabilitation training, and periodic evaluation of quality of life.
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.
Active Comparator: Routine Care

Participants received standard institutional postoperative care for CABG, which primarily focused on the inpatient period. Key elements included:

  • Monitoring of vital signs, consciousness, and peripheral circulation.
  • Management of respiratory tract patency and urinary catheters.
  • Hourly monitoring of drainage tubes initially.
  • Wound care and monitoring for bleeding.
  • Body temperature monitoring and oral care.
  • Guidance on progressing from liquid diets.
  • Standard discharge instructions without structured post-discharge follow-up.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (preoperatively) and Day 7 post-surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 hours, 72 hours, and 14 days post-surgery.
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 %).
Day 7 post-surgery.
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.
Day 7 post-surgery.
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.
Day 14 post-surgery.
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.
Day 14 post-surgery.
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.
Day 14 post-surgery.
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.
Up to 14 days post-surgery (at time of hospital discharge).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

July 2, 2025

First Submitted That Met QC Criteria

July 10, 2025

First Posted (Actual)

July 14, 2025

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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