NCT07519733 · Yale University
Preoperative Exercise Testing and Perioperative Outcomes
(SAMPO)
What this study is about
The goal of this observational study is to learn whether results from a brief exercise test done before surgery can help identify adults who may be more likely to have problems after moderate- to high-risk noncardiac surgery.
View original scientific description
The goal of this observational study is to learn whether results from a brief exercise test done before surgery can help identify adults who may be more likely to have problems after moderate- to high-risk noncardiac surgery. The study includes adults older than 45 years who are seen in a pre-surgical evaluation clinic and complete submaximal cardiopulmonary exercise testing, or smCPET, as part of their usual clinical care. The main questions it aims to answer are: Are smCPET measurements linked with early problems after surgery? Are smCPET measurements linked with later problems after surgery, including complications within 30 and 60 days, longer hospital stay, and death? Can smCPET add useful information to standard preoperative risk assessment? Researchers will observe and analyze information collected during routine care. No extra exercise testing or treatment will be done for research. Participants will: * Complete routine preoperative evaluation in the Yale Pre-Surgical Evaluation Clinic. * Undergo smCPET if it is ordered as part of standard clinical care. * Allow researchers to collect information from the medical record and from the exercise test for the study repository, if they agree to participate. The study will collect de-identified information about each participant's health before surgery, exercise test results, details about the surgery and hospital stay, and problems that happen after surgery. This may include age, sex, body mass index, other medical conditions, routine lab and imaging results, heart rate, blood pressure, oxygen levels, smCPET measures such as peak oxygen uptake, anaerobic threshold, and breathing efficiency, and early and late postoperative outcomes. Researchers will look at short-term and later outcomes after surgery. These include problems identified during the hospital stay, such as heart, lung, kidney, nerve, blood, wound, and pain-related complications, as well as complications within 30 and 60 days after surgery. Researchers will also study hospital length of stay and death after surgery. This study is designed to help researchers understand whether a short, practical exercise test can improve the way surgical risk is assessed before an operation. Current preoperative assessment tools do not always measure how well the heart, lungs, and muscles work together during physical stress. smCPET may provide a more objective way to measure functional capacity and physiologic reserve in a busy clinic setting. This is a single-center study based in a preoperative evaluation clinic. The study has a prospective observational cohort component and a retrospective validation component. In the prospective part, adults who meet clinic criteria and complete smCPET during routine care may be asked to join the repository. In the retrospective part, researchers may also review historical data from patients evaluated before smCPET was put into routine use to help compare outcomes and validate findings. Because this is an observational repository study, participation does not change the care participants receive. The exercise test is done for clinical reasons, not because of the research study. The research team will not assign treatments or decide what surgery a participant has. Instead, the team will study how exercise test findings relate to outcomes that occur after surgery. The long-term aim of this study is to improve preoperative risk assessment and help clinicians better identify patients who may need closer monitoring, more evaluation, or more support around the time of surgery. If the findings are useful, they may support broader use of brief preoperative exercise testing in adults having higher-risk noncardiac surgery.
Interventions
DIAGNOSTIC_TEST
Recruited participants receive preoperative rapid submaximal cardiopulmonary exercise testing within the current risk assessment framework of the pre-surgical evaluation clinic
A six minute submaximal cardiopulmonary exercise test that is used to identify cardiopulmonary abnormalities associated with heart and lung disease. This seeks to aid the physician in prescribing preoperative interventions to reduce postoperative cardiopulmonary complications.
Primary outcome measures
Major adverse cardiovascular events
Time frame: 30 days
Composite Cardiovascular death, acute heart failure, cardiac arrythymias, perioperative myocardia infarction/injury in the 30 days after surgical procedure.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- greater than 45 years old
- moderate to high-risk noncardiac surgery
- surgeon, anesthesiologist or other medical provider requested referral for preoperative high risk evaluation, or
- revised cardiac risk index \> or = 2, or
- Ambiguous, low or discordant functional capacity by either the Duke Activity status index (DASI \<34) or the modified Duke Activity status index (\< or =3) or
- Frailty Index \>1
Exclusion criteria
- Absolute contraindication to submaximal cardiopulmonary exercise testing
- Impaired decision making capacity
- Severe peripheral vascular disease
- Functional limitation precluding the performance of submaximal cardipulmonary exercise testing
- Severe active pulmonary disease
Where
- New Haven, Connecticut
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2026 · Source of record for eligibility and locations