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

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.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new physical fitness test called the SHAPE test as a way to predict cardiac risk in older patients who are preparing for moderate to high-risk non-cardiac surgery. Before major surgery, doctors try to assess how well a patient's heart and lungs can handle the physical stress of the procedure. The SHAPE test involves a series of physical maneuvers and is intended as a quick, practical alternative to more expensive or complex cardiac stress testing — helping identify patients who are at risk of serious heart events during or after surgery. Participants must be over 60 years old, scheduled for pre-surgical evaluation for a moderate or high-risk procedure, and have a Revised Cardiac Risk Index (RCRI) below 2 (meaning they don't already have obvious high cardiac risk). People with recent heart attacks, unstable angina, severe valve disease, recent heart failure, current lung conditions, or physical limitations that prevent performing the SHAPE test are excluded. This research matters because cardiac complications are a leading cause of death after major non-cardiac surgery, and better pre-operative risk stratification could save lives. Many patients currently undergo unnecessary — and expensive — cardiac testing, while others are undertested. A simple, accurate, and low-cost functional test like SHAPE could improve efficiency and accuracy in surgical preparation, helping anesthesiologists and surgeons make better, more personalized decisions about timing and approach.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEShape II

cardiopulmonary exercise testing apparatus


Locations(1)

Yale New Haven Hospital

New Haven, Connecticut, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05743673


Related Trials