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SHAPE Test for Preoperative Risk Stratification

NCT05743673 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 371

Last updated 2026-05-07

No results posted yet for this study

Summary

This study is looking at whether a simplified exercise test called the SHAPE-HF cardiopulmonary testing system can be used before surgery in older adults. Doctors often need to know how well a patient's heart, lungs, and body handle physical activity before moderate- to high-risk surgery. This information may help them better understand a patient's fitness for surgery and possible risk of complications afterward.

The study will enroll adults older than 60 years who are being evaluated before planned moderate- to high-risk noncardiac surgery. The first goal is to determine if this was feasible in older adults and to learn whether patients can be successfully recruited to complete this pre-surgery test. Secondly, the study will also look at how results from the SHAPE-HF system compare with common ways doctors now estimate fitness, such as asking patients about their physical activity and using a standard questionnaire.

Participants will attend one in-person study visit lasting about 35 minutes. During that visit, they will answer questions about their activity level and complete testing with the SHAPE-HF system. The test uses short periods of lower-intensity exercise to estimate aerobic fitness. After the visit, participants will be contacted by phone about 24 hours later to check for any problems related to the study test.

Lastly, researchers will also review information from the medical record for 30 days after surgery to see whether test results are related to recovery, short-term health problems after surgery, or major complications. No extra surgery or change in planned medical care is part of this study. The information learned may help improve how doctors evaluate older adults before surgery in the future.

Conditions

  • Perioperative/Postoperative Complications
  • Aerobic Capacity

Interventions

DEVICE

Shape II

cardiopulmonary exercise testing apparatus

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Zyad J Carr, M.D. · Yale University

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-03
Primary Completion
2026-05-29
Completion
2026-05-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05743673 on ClinicalTrials.gov