SHAPE Test for Preoperative Risk Stratification

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorYale University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Age <60 years old

Subjective METS <4

Inability to give independent informed consent

Revised Cardiac Risk Index (RCRI) >2

Trial population

The overall goal is the 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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Shape II

    Device

    cardiopulmonary exercise testing apparatus

Treatment groups

371 Participants
are divided into 1 treatment group
Group A: Validation Cohort1 intervention

Trial outcomes

Primary outcomes

1

Recruitment Success

The primary objective for the study is a study enrollment rate of 25% of eligible candidates. Within the parameters of a feasibility study, the following questions will also be addressed: * Physical capacity of clinic to handle the number of participants in the study. * Adequate communication and time frame to efficiently perform abbreviated cardiopulmonary exercise testing in high-volume preoperative testing environment. * Adequate software and hardware to capture and use data obtained from abbreviated cardiopulmonary exercise testing. * Determination of adequate institutional, departmental and clinical support to maintain and perform abbreviated cardiopulmonary exercise testing as an adjunct for preoperative testing. * Does abbreviated cardiopulmonary testing in a preoperative testing environment improve access to care in a diverse and at-risk surgical population

Time frame
0-30 days

Secondary outcomes

1

Conventional measure of metabolic equivalents (METS)

If conventional measures of METS (subjective METS, Duke Activity Status Index) compare favorably to the SHAPE testing performance variables.

Time frame
0-1 day
2

Perioperative Morbidity Survey

• If SHAPE™ performance variables predict a higher risk of postoperative morbidity after surgery using the Postoperative Operative Morbidity Survey (POMS), a short-term measure of postoperative morbidity after major elective surgery.

Time frame
0-30 days
3

Major postoperative outcomes

• If SHAPE™ performance variables predict a higher risk of postoperative major morbidity as measured by traditional major 30-day complications (myocardial infarction, stroke, atrial fibrillation, surgical site infection, postoperative pulmonary complications)

Time frame
0-30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.