Cardiac SurgeryPRO-CARDSNCT05684354
Patient Reported Outcome (PRO) in CARDiac Surgery.
An observational study of Cardiac Surgery, run by Rennes University Hospital at 1 site in France.
Trial summary
The use of Patient Reported Outcomes (PROs) in anaesthesia provides a measure of the patient's quality of postoperative recovery based on his/her own experience. The Quality-Of-Recovery-15 (QoR-15) is a widely used questionnaire which has never been validated in cardiac surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Patient Reported Outcomes (PROs)
- How many people
- 156 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2022to 20 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients scheduled for cardiac surgery under CPB including valve surgery, coronary artery bypass, ascending aorta surgery, combined procedure, and had given oral informed consent. Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty, patients unable to complete the questionnaire independently (cognitive deficit or poor French comprehension) and pregnant or breastfeeding women were not included
Who may be able to join
- Patients over 18 years old
- Hospitalized for planned cardiac surgery among: coronary artery bypass grafting, valve plasty, valve replacement or ascending aortic surgery
- Patient not opposing his participation in the research
- Non-inclusion criteria:
- Adults subject to legal protection (safeguard of justice, curatorship, guardianship)
- Persons deprived of liberty
- Patient unable to complete the questionnaire independently (cognitive deficit or patient who does not speak French)
- Pregnant or breastfeeding women
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Quality of Recovery-15 Score in Cardiac Surgery: The PROCARDS Study
The use of Patient Reported Outcomes (PROs) in anaesthesia provides a measure of the patient's quality of postoperative recovery based on his/her own experience. The Quality-Of-Recovery-15 (QoR-15) is a widely used questionnaire which has never been validated in cardiac surgery patients.
This study aimed at validating the French version of the QoR-15 scale in a cohort of cardiac surgical patients. The QoR-15 scale would have similar psychometric properties and interpretability in assessing postoperative recovery in this population than in general surgery patients.
Read the detailed description
The French version of the QoR-15 scale as validated by Demumieux et al was used in this study. Eligible patients were given oral and written information the day before or the morning before surgery. After patient agreed to participate, the first QoR-15 scale was distributed by one of the investigators. The patient filled in the questionnaire alone or could be helped by one of the investigators in case of questions or difficulties.
The second QoR-15 scale was distributed the day before or the day of discharge from the hospital and at the same time the patient was asked to rate his global recovery on a visual analog scale (VAS) graduated from 0 to 100 with 0 being the worst recovery and 100 the best recovery.
Patient demographic characteristics were collected including age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) physical status score, preoperative status of diabetes, hypertension, smoking status. Following perioperative data were recorded: type of surgery, duration of CPB, need for cardiac pacing or dobutamine support at the end of surgery, number of pleural and mediastinal chest tubes.
Postoperative complications were also recorded: surgical revision, atrial fibrillation requiring antiarrhythmic medication or anticoagulation, pulmonary oedema requiring depletion, drained pleural effusion, drained pneumothorax, radiological atelectasis, radiologic pneumonia, stroke with radiological diagnosis, sepsis as defined by Third International Consensus Definitions for Sepsis and Septic Shock [Sepsis-3], Heparin-induced thrombocytopenia (HIT) documented by Serotonin release assay test. Total dose of morphine used in ICU, length of stay (LOS) in ICU and hospital, duration of surgical drains and mortality at day 28 were also assessed.
Statistical analysis Sample size was The sample size was estimated at 150 patients and based on previous published studies(7,8) and guidelines recommending at least 10 subjects per item on the instrument scale(15). Data were reported as mean, median (inter-quartile range), or number (percentage) as appropriate. Correlations were calculated with Pearson correlation coefficient for Gaussian data or with Spearman correlation coefficient for non-Gaussian data. Factors associated with the QOR-15 score were searched by Analysis of Variance (ANOVA) for qualitative parameters and by linear regression for quantitative parameters. The null hypothesis was rejected if two-tailed P-value was inferior to 0.05
- Conditions
- Cardiac Surgery
- Being tested
- Patient Reported Outcomes (PROs)
- Keywords
- cardiac, surgery, postoperative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Reported Outcomes (PROs)Other
The day before or the morning before surgery, the patient filled the first QoR-15 scale alone or could be helped by one of the investigators in case of questions or difficulties.
The second QoR-15 scale was distributed the day before or the day of discharge from the hospital
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the validity of QoR-15 in the post-operative period of cardiac surgery
Validity (the accuracy of a scale - does the QoR-15 measure what is intended: the quality of postoperative recovery). Convergent validity was tested by the hypothesis that there would be a positive correlation between the postoperative QoR-15 score and the global recovery assessment by the patient, or between the QoR-15 (postoperative-preoperative QoR-15 scores) and the global recovery assessment. Construct validity was tested by the hypothesis that there would be a negative association between the QoR-15 score and various known determinants of postoperative recovery
Measured: Day 5
Secondary outcomes (3)
Assess the Reliability of QoR-15 in the post-operative period of cardiac surgery
Reliability (the consistency of a scale) was tested by internal consistency (Cronbach's alpha)
Measured: Day 5
Assess the Responsiveness of QoR-15 in the post-operative period of cardiac surgery
Responsiveness (ability of a scale to detect clinically important change) was assessed by Cohen size effect and standardized response mean.
Measured: Day 5
Assess the Feasibility of QoR-15 in the post-operative period of cardiac surgery
Feasibility (applicability of a scale in practice) was evaluated by the successful completion rate
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start27 Jul 2022
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grégoire LE GAC, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684354
- Sponsor's protocol ID
- 35RC22_3088 PROCARDS
- Acronym
- PRO-CARDS
- Status last verified
- Jan 2023
- First submitted
- 5 Jan 2023
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Quality of Recovery-15 Score in Cardiac Surgery: The PROCARDS Study
- ClinicalTrials.gov ID
- NCT05684354
- Acronym / sponsor ID
- PRO-CARDS / 35RC22_3088 PROCARDS
- Conditions
- Cardiac Surgery
- Keywords
- cardiac, surgery, postoperative care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 13 Jan 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.
The use of Patient Reported Outcomes (PROs) in anaesthesia provides a measure of the patient's quality of postoperative recovery based on his/her own experience. The Quality-Of-Recovery-15 (QoR-15) is a widely used questionnaire which has never been validated in cardiac surgery patients.
This study aimed at validating the French version of the QoR-15 scale in a cohort of cardiac surgical patients. The QoR-15 scale would have similar psychometric properties and interpretability in assessing postoperative recovery in this population than in general surgery patients.
Detailed description
The French version of the QoR-15 scale as validated by Demumieux et al was used in this study. Eligible patients were given oral and written information the day before or the morning before surgery. After patient agreed to participate, the first QoR-15 scale was distributed by one of the investigators. The patient filled in the questionnaire alone or could be helped by one of the investigators in case of questions or difficulties.
The second QoR-15 scale was distributed the day before or the day of discharge from the hospital and at the same time the patient was asked to rate his global recovery on a visual analog scale (VAS) graduated from 0 to 100 with 0 being the worst recovery and 100 the best recovery.
Patient demographic characteristics were collected including age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) physical status score, preoperative status of diabetes, hypertension, smoking status. Following perioperative data were recorded: type of surgery, duration of CPB, need for cardiac pacing or dobutamine support at the end of surgery, number of pleural and mediastinal chest tubes.
Postoperative complications were also recorded: surgical revision, atrial fibrillation requiring antiarrhythmic medication or anticoagulation, pulmonary oedema requiring depletion, drained pleural effusion, drained pneumothorax, radiological atelectasis, radiologic pneumonia, stroke with radiological diagnosis, sepsis as defined by Third International Consensus Definitions for Sepsis and Septic Shock [Sepsis-3], Heparin-induced thrombocytopenia (HIT) documented by Serotonin release assay test. Total dose of morphine used in ICU, length of stay (LOS) in ICU and hospital, duration of surgical drains and mortality at day 28 were also assessed.
Statistical analysis Sample size was The sample size was estimated at 150 patients and based on previous published studies(7,8) and guidelines recommending at least 10 subjects per item on the instrument scale(15). Data were reported as mean, median (inter-quartile range), or number (percentage) as appropriate. Correlations were calculated with Pearson correlation coefficient for Gaussian data or with Spearman correlation coefficient for non-Gaussian data. Factors associated with the QOR-15 score were searched by Analysis of Variance (ANOVA) for qualitative parameters and by linear regression for quantitative parameters. The null hypothesis was rejected if two-tailed P-value was inferior to 0.05
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients scheduled for cardiac surgery under CPB including valve surgery, coronary artery bypass, ascending aorta surgery, combined procedure, and had given oral informed consent. Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty, patients unable to complete the questionnaire independently (cognitive deficit or poor French comprehension) and pregnant or breastfeeding women were not included
Key inclusion criteria (8 listed)
- Patients over 18 years old
- Hospitalized for planned cardiac surgery among: coronary artery bypass grafting, valve plasty, valve replacement or ascending aortic surgery
- Patient not opposing his participation in the research
- Adults subject to legal protection (safeguard of justice, curatorship, guardianship)
- Persons deprived of liberty
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Reported Outcomes (PROs)The day before or the morning before surgery, the patient filled the first QoR-15 scale alone or could be helped by one of the investigators in case of questions or difficulties. The second QoR-15 scale was distributed the day before or the day of discharge from the hospital | Other | – |
Primary outcome
Assess the validity of QoR-15 in the post-operative period of cardiac surgery
Time frame: Day 5
Validity (the accuracy of a scale - does the QoR-15 measure what is intended: the quality of postoperative recovery). Convergent validity was tested by the hypothesis that there would be a positive correlation between the postoperative QoR-15 score and the global recovery assessment by the patient, or between the QoR-15 (postoperative-preoperative QoR-15 scores) and the global recovery assessment. Construct validity was tested by the hypothesis that there would be a negative association between the QoR-15 score and various known determinants of postoperative recovery
3 secondary outcomes
Assess the Reliability of QoR-15 in the post-operative period of cardiac surgery
Time frame: Day 5
Assess the Responsiveness of QoR-15 in the post-operative period of cardiac surgery
Time frame: Day 5
Assess the Feasibility of QoR-15 in the post-operative period of cardiac surgery
Time frame: Day 5
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 13 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
Grégoire LE GAC principal investigator
Rennes University Hospital
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 Cardiac Surgery, run by Rennes University Hospital at 1 site in France.
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 8 inclusion and 0 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 13 Jan 2023. 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 France. 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?
Assess the validity of QoR-15 in the post-operative period of cardiac surgery (time frame: Day 5). 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 13 Jan 2023.