RecruitingNCT05743673

SHAPE Test for Preoperative Risk Stratification

A Feasibility Study of the SHAPE™ Test of Aerobic Fitness in Older Adults Presenting for Moderate to High-risk Surgery

Sponsor

Yale University

Enrollment

371 participants

Start Date

May 3, 2023

Study Type

OBSERVATIONAL

Conditions

Perioperative/Postoperative Complications

Summary

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.

Eligibility

Min Age: 60 Years

Inclusion Criteria4

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 Criteria21

Age \<60 years old
Subjective METS \<4
Inability to give independent informed consent
Revised Cardiac Risk Index (RCRI) \>2
Neurological impairment with motor limitations
Mental impairment leading to inability to cooperate
Recent 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 edema
Uncontrolled symptomatic arrhythmias
Active endocarditis
Acute myocarditis or pericarditis
Active wheezing or home oxygen use
Recent 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 irregularities
Diagnosis of vertigo
Known 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.