Development, Validation and Clinical Application of a Recovery Scale After Cardiac Surgery: the Fuwai-CRS (Fuwai- Cardiac Recovery Scale)

Completed

• Conditions: Postoperative Recovery; Cardiac Surgery; PROM

• Registration Number: NCT05782036
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

Improving patient recovery after cardiac surgery is a critical priority. While improved surgical techniques have substantially reduced procedural mortality over the past decades, the inherent physiological insult of median sternotomy, cardiopulmonary bypass, and myocardial manipulation continues to impose significant challenges in patient's recovery experience, such as pain, sleep disorders. Paradoxically, this critical recovery phase remains underexplored, as traditional outcome metrics predominantly focus on mortality and major morbidity endpoints. However, no cardiac surgery-specific tools currently exist to adequately capture postoperative recovery experience, creating barriers to optimal care. Accordingly, the investigators aim to develop and validate a recovery scale after cardiac surgery and evaluate its clinical performance compared to the generic scale (QoR-15)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-03-23
• Study Start: 2023-05-16
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3043

Inclusion Criteria

• Elective cardiac surgery

Exclusion Criteria

• Emergency surgery
• Age ≤ 18 years
• Refuse to participate in this study
• prolonged postoperative mechanical ventilation exceeding 24 hours reoperation or perioperative death

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death or unplanned readmission	3-month post operative

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality	From surgery to discharge, up to 7 days	Occurrence of death during hospitalization
In-hospital stroke	From surgery to discharge, up to 7 days	Occurrence of stroke during hospitalization
In-hospital myocardial infarction	From surgery to discharge, up to 7 days	Occurrence of myocardial infarction during hospitalization
In-hospital acute renal failure	From surgery to discharge, up to 7 days	Occurrence of acute renal failure during hospitalization
In-hospital sternal wound infection	From surgery to discharge, up to 7 days	Occurrence of sternal wound infection during hospitalization
In-hospital reoperation	From surgery to discharge, up to 7 days	Occurrence of reoperation during hospitalization
Length of hospital stay	Approximately 7 days	Length of hospital stay

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, Beijing, China