RECRUITING

SHAPE Test for Preoperative Risk Stratification

Description

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.

Conditions

Perioperative/Postoperative ComplicationsAerobic Capacity
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Related Conditions:

Perioperative/Postoperative ComplicationsAerobic Capacity

Study Overview

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Study Details

Study overview

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.

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

SHAPE Test for Preoperative Risk Stratification

Condition
Perioperative/Postoperative Complications
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale New Haven Hospital, New Haven, Connecticut, United States, 06520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Yale University,

Zyad J Carr, M.D., PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2026-05-29