Preoperative submaximal exercise testing to predict outcomes after moderate- to high-risk noncardiac surgery

Submaximal Cardiopulmonary Exercise Testing in Adults Presenting for Moderate to High-risk Surgery and Perioperative Outcomes

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
• Enrollment: 992 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: Yale University (other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT07519733 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

New Haven, Connecticut

• 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.

Conditions: Postoperative Complications, preoperative evaluation, submaximal cardiopulmonary exercise testing, major adverse cardiovascular events, preoperative risk stratification, high risk evaluation