SHAPE Test for Preoperative Risk Stratification

Primary Objective Characterizing precise functional capacity in surgical patients is critical for risk stratification and identification of patients at high risk for perioperative complications. The primary objective for the study is to evaluate the feasibility of effective subject recruitment of an FDA-approved simplified cardiopulmonary exercise testing apparatus in adults >60 years old prior to moderate to high-risk surgery. In addition, by development of a validation cohort of older adults, defined as >60 years old, self-reporting >4 METS and with a score of <2 on the revised cardiac risk index (RCRI)1 we will compare its effectiveness when compared to conventional preoperative evaluation measures (METS determination by standard scoring and Duke Activity Status Index) to SHAPE™ testing.

Inclusion Criteria:Aged >60 yearsScheduled 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 formExclusion Criteria:Age <60 years oldSubjective METS <4Inability to give independent informed consentRevised Cardiac Risk Index (RCRI) >2Neurological impairment with motor limitationsMental impairment leading to inability to cooperateRecent NSTEMI or STEMI type myocardial infarction (within 6 months)Angina (stable or unstable, within 6 months)Uncorrected severe valvular heart disease (severe aortic, tricuspid, or mitral stenosis)Recent exacerbation of congestive heart failure (requiring hospitalization, within 6 months)Acute pulmonary embolism or deep vein thrombosis (within past 6 months)Uncontrolled pulmonary edemaUncontrolled symptomatic arrhythmiasActive endocarditisAcute myocarditis or pericarditisActive wheezing or home oxygen useRecent exacerbation of chronic obstructive pulmonary disease or asthma or pneumonia (requiring hospitalization, within 6 months)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 irregularitiesDiagnosis of vertigoKnown allergic reactions to components of the SHAPE medical system apparatus disposable mouthpiece.Active enrollment in an interventional clinical trial within the enrollment period of the study.