Postoperative RecoveryNCT05782036
Development, Validation and Clinical Application of a Recovery Scale After Cardiac Surgery: the Fuwai-CRS (Fuwai- Cardiac Recovery Scale)
An observational study of Postoperative Recovery and Cardiac Surgery, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Recovery, Cardiac Surgery, PROM
- How many people
- 3,043 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient aged 18 years or older, undergoing elective cardiac surgery.
Who may be able to join
- Elective cardiac surgery
Who cannot join
- Emergency surgery
- Age ≤ 18 years
- Refuse to participate in this study
- prolonged postoperative mechanical ventilation exceeding 24 hours reoperation or perioperative death
Trial locations and contacts
1 site in 1 country.
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Item generation | Not described | |
| Cohort 2: Item finalization and validation | Not described | |
| Cohort 3: Clinical application | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or unplanned readmission
Measured: 3-month post operative
Secondary outcomes (7)
In-hospital mortality
Occurrence of death during hospitalization
Measured: From surgery to discharge, up to 7 days
In-hospital stroke
Occurrence of stroke during hospitalization
Measured: From surgery to discharge, up to 7 days
In-hospital myocardial infarction
Occurrence of myocardial infarction during hospitalization
Measured: From surgery to discharge, up to 7 days
In-hospital acute renal failure
Occurrence of acute renal failure during hospitalization
Measured: From surgery to discharge, up to 7 days
In-hospital sternal wound infection
Occurrence of sternal wound infection during hospitalization
Measured: From surgery to discharge, up to 7 days
In-hospital reoperation
Occurrence of reoperation during hospitalization
Measured: From surgery to discharge, up to 7 days
Length of hospital stay
Length of hospital stay
Measured: Approximately 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start16 May 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative RecoveryStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,043 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782036
- Sponsor's protocol ID
- 2022-1882
- Status last verified
- Apr 2025
- First submitted
- 17 Feb 2023
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Validation and Clinical Application of a Recovery Scale After Cardiac Surgery: the Fuwai-CRS (Fuwai- Cardiac Recovery Scale)
- ClinicalTrials.gov ID
- NCT05782036
- Acronym / sponsor ID
- 2022-1882
- Conditions
- Postoperative Recovery, Cardiac Surgery, PROM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,043 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 16 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Item generation | – | – |
| Cohort 2: Item finalization and validation | – | – |
| Cohort 3: Clinical application | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient aged 18 years or older, undergoing elective cardiac surgery.
Key inclusion criteria (1 listed)
- Elective cardiac surgery
Key exclusion criteria (4 listed)
- Emergency surgery
- Age ≤ 18 years
- Refuse to participate in this study
- prolonged postoperative mechanical ventilation exceeding 24 hours reoperation or perioperative death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death or unplanned readmission
Time frame: 3-month post operative
7 secondary outcomes
In-hospital mortality
Time frame: From surgery to discharge, up to 7 days
In-hospital stroke
Time frame: From surgery to discharge, up to 7 days
In-hospital myocardial infarction
Time frame: From surgery to discharge, up to 7 days
In-hospital acute renal failure
Time frame: From surgery to discharge, up to 7 days
In-hospital sternal wound infection
Time frame: From surgery to discharge, up to 7 days
In-hospital reoperation
Time frame: From surgery to discharge, up to 7 days
Length of hospital stay
Time frame: Approximately 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Recovery and Cardiac Surgery, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or unplanned readmission (time frame: 3-month post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.