SHAPE Test for Preoperative Risk Stratification

Launched by YALE UNIVERSITY · Feb 14, 2023

Keywords

ClinConnect Summary

The SHAPE clinical trial is studying a new way to assess the fitness of older adults before they undergo moderate to high-risk surgeries. The main goal is to see if a simpler breathing test, called the SHAPE test, can effectively identify patients who may be at higher risk for complications during or after their surgery. This test will be compared to traditional methods of evaluation to determine how well it works.

To be eligible for the trial, participants need to be over 60 years old and scheduled for surgery. They should have a specific score indicating they are at low risk for heart problems based on their medical history. If you join the study, you will undergo the SHAPE test along with other standard tests to help doctors better understand your health before surgery. This trial is currently looking for participants, so if you or a loved one fit the criteria and are interested, it could be a valuable opportunity to contribute to medical research that aims to improve patient care.

Gender

ALL

Eligibility 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.