Evaluating a new test for assessing surgical risks in older patients
A Feasibility Study of the SHAPE™ Test of Aerobic Fitness in Older Adults Presenting for Moderate to High-risk Surgery
This study is testing a new exercise test called SHAPE™ to see if it can better predict surgery risks for older adults than the usual methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 371 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05743673 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the feasibility of using the SHAPE™ test, an FDA-approved cardiopulmonary exercise testing system, to evaluate functional capacity in adults over 60 years old scheduled for moderate to high-risk surgeries. The study will compare the effectiveness of SHAPE™ testing against traditional preoperative evaluation measures, focusing on its ability to predict postoperative complications. By recruiting a validation cohort of older adults, the research seeks to enhance risk stratification and improve patient outcomes during surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 60 years old who are scheduled for moderate to high-risk surgical procedures and have a revised cardiac risk index score of less than 2.
Not a fit: Patients under 60 years old or those with significant cardiac or pulmonary conditions that exceed the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better identification of high-risk surgical patients, potentially reducing postoperative complications and improving recovery outcomes.
How similar studies have performed: Other studies have shown success with similar cardiopulmonary exercise testing approaches, indicating potential for this method to be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged \>60 years * Scheduled for pre-surgical evaluation for moderate to high-risk surgical procedure. * RCRI \<2 based on screening of preoperative co-morbidities. * Provision of signed and dated informed consent form Exclusion Criteria: 1. Age \<60 years old 2. Subjective METS \<4 3. Inability to give independent informed consent 4. Revised Cardiac Risk Index (RCRI) \>2 5. Neurological impairment with motor limitations 6. Mental impairment leading to inability to cooperate 7. Recent NSTEMI or STEMI type myocardial infarction (within 6 months) 8. Angina (stable or unstable, within 6 months) 9. Uncorrected severe valvular heart disease (severe aortic, tricuspid, or mitral stenosis) 10. Recent exacerbation of congestive heart failure (requiring hospitalization, within 6 months) 11. Acute pulmonary embolism or deep vein thrombosis (within past 6 months) 12. Uncontrolled pulmonary edema 13. Uncontrolled symptomatic arrhythmias 14. Active endocarditis 15. Acute myocarditis or pericarditis 16. Active wheezing or home oxygen use 17. Recent exacerbation of chronic obstructive pulmonary disease or asthma or pneumonia (requiring hospitalization, within 6 months) 18. Inability to perform components of the SHAPE test (severe hip flexion limitation, severe osteoarthritis of knee or hip, limb immobilization, ambulation with a walker, can or crutches, baseline balance irregularities 19. Diagnosis of vertigo 20. Known allergic reactions to components of the SHAPE medical system apparatus disposable mouthpiece. 21. Active enrollment in an interventional clinical trial within the enrollment period of the study.
Where this trial is running
New Haven, Connecticut
- Yale New Haven Hospital — 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.