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

NCT05782036 | Completed DMC

• 1 other identifier: 2022-1882
• Study Type: observational
• Target: 3,043
• Locations: 1 country
• Sites: 1

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)

Conditions

Postoperative Recovery; Cardiac Surgery; PROM

Outcome Measures

Primary Outcomes (1)

• Death or unplanned readmission

  3-month post operative

Secondary Outcomes (7)

• In-hospital mortality

  From surgery to discharge, up to 7 days

• In-hospital stroke

  From surgery to discharge, up to 7 days

• In-hospital myocardial infarction

  From surgery to discharge, up to 7 days

• In-hospital acute renal failure

  From surgery to discharge, up to 7 days

• In-hospital sternal wound infection

  From surgery to discharge, up to 7 days

Study Arms (3)

Cohort 1: Item generation

Cohort 2: Item finalization and validation

Cohort 3: Clinical application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient aged 18 years or older, undergoing elective cardiac surgery.

You may qualify if:

• Elective cardiac surgery

You may not qualify if:

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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100032, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 23, 2023
• Study Start: May 16, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

CN (1)