Preoperative submaximal exercise testing to predict outcomes after moderate- to high-risk noncardiac surgery
Official title: Submaximal Cardiopulmonary Exercise Testing in Adults Presenting for Moderate to High-risk Surgery and Perioperative Outcomes
Run by Yale University · NCT07519733 · Data updated 2026-11-12
This study will test whether a brief submaximal cardiopulmonary exercise test done before moderate- to high-risk noncardiac surgery can help predict which adults over 45 are more likely to have problems after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 45 Years and up |
| Sex | All |
| Enrollment | 992 (estimated) |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Status | Recruiting |
| Started | July 23, 2025 |
| Main results expected | January 30, 2028 |
| Study ends | July 30, 2028 |
| Registry record updated | April 9, 2026 |
| Trial ID | NCT07519733 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults older than 45 who are scheduled for moderate- to high-risk noncardiac surgery and referred for high-risk preoperative evaluation or who meet criteria such as RCRI ≥2, low/ambiguous functional capacity (DASI <34 or modified DASI ≤3), or frailty index >1 are ideal candidates.
✕Probably not a fit
People under 45, those having low-risk procedures, or patients who cannot perform smCPET because of contraindications, severe active pulmonary disease, or major functional limitations are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center prospective observational cohort collects routinely obtained brief submaximal cardiopulmonary exercise testing (smCPET) data from adults presenting to a pre-surgical evaluation clinic and links those measurements to perioperative outcomes. Researchers will combine exercise-derived physiologic measures with clinical, perioperative, and postoperative outcome data to see whether smCPET variables relate to complications within 30 and 60 days, length of stay, and mortality. No additional testing or interventions are performed for the research; all data come from routine care and chart review, with a retrospective validation component. The repository is designed to support development of scalable perioperative risk models that could be applied in future implementation studies.
Why it matters
Potential benefit: If successful, adding brief smCPET to routine preoperative evaluation could help clinicians identify higher-risk patients so they can plan tailored perioperative care and monitoring.
How similar studies have gone: Formal, full cardiopulmonary exercise testing has shown predictive value for perioperative risk, but brief clinically integrated submaximal CPET in routine preoperative clinics is less validated and represents a partially novel, pragmatic approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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: * Age \<45 * Absolute contraindication to submaximal cardiopulmonary exercise testing * Impaired decision making capacity * Prisoners * Pregnancy * Severe peripheral vascular disease * Functional limitation precluding the performance of submaximal cardipulmonary exercise testing * Severe active pulmonary disease
Where it's running
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Yale New Haven Hospital, Pre-Surgical Evaluation Clinic
New Haven, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Zyad J Carr, M.D. — Yale University
- Study coordinator: Zyad J Carr, M.D.
- Email: zyad.carr@yale.edu
- Phone: 203.785.3689
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.