SHAPE Test for Preoperative Risk Stratification

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05743673
Status
Recruiting
Apply to this trial

Conditions

  • Aerobic Capacity
  • Perioperative/Postoperative Complications

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Shape II — DEVICE
    cardiopulmonary exercise testing apparatus

Study Details

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.

Key Dates

Start date
May 3, 2023
Status verified
Apr 2026
Primary completion
May 29, 2026
Completion
May 29, 2026

Study Design

Enrollment
371 participants (estimated)

Arms

  • Arm: Validation Cohort
    Older subjects (\>60 years old) presenting for moderate to high-risk surgical procedure with reported subjective metabolic equivalents of \>4 METS and with a score of \<4 on the revised cardiac risk index (RCRI) undergoing submaximal exercise testing.

Primary Outcome Measure

Recruitment Success [ Time Frame: 0-30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06520-

Find similar trials in New Haven, CT

By research site
Yale New Haven Hospital· New Haven, CT

Related Studies