SHAPE Test for Preoperative Risk Stratification

Recruiting

• Conditions: Perioperative/Postoperative Complications; Aerobic Capacity
• Interventions: Device: Shape II

• Registration Number: NCT05743673
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

The submaximal heart and pulmonary evaluation (SHAPE™) test is an FDA approved cardiopulmonary exercise testing (CPET) system that provides a rapid and non-invasive way of characterizing cardiopulmonary reserve in a variety of medical conditions3,4. Traditional CPET testing has demonstrated predictive power in the assessment of postoperative mortality, hospital length of stay and other postoperative complications after lung resection, abdominal aortic aneurysm repair and liver transplants5-7. A unique advantage of SHAPE™ testing is that functional capacity variables are both obtained at rest and during sub-maximal exercise, potentially mimicking elicited conditions associated with surgical stress, as well as assist in determining the specific component of the physiological system under duress during testing (cardiac vs. pulmonary). Additionally, unlike conventional CPET, a maximum exercise effort is not required, making it an attractive option for patients with cardiopulmonary or musculoskeletal disorders and elderly patients who are unable to undergo the higher intensity exercise testing associated with traditional CPET. Finally, investigation of unique SHAPE™ variables (e.g. GXcap/Δend-tidal C02) which have been observed to be sensitive performance indicators for a variety of cardiovascular diseases such as heart failure with preserved ejection fraction, may prove more sensitive to traditional CPET variables or conventional echocardiography3.

This is a prospective, non-randomized feasibility study to evaluate the effectiveness of subject recruitment of an FDA-approved simplified cardiopulmonary exercise testing apparatus in adults \>60 years old prior to moderate to high-risk surgery. Pre-screened research subjects will be approached by telephone or in-person within the pre-surgical evaluation clinic prior to their surgery. We hypothesize that \>25% of eligible subjects will be recruited in the investigation. A single 35 minute in-person session will be performed where subjective metabolic equivalents will be assessed, and experimental session of the SHAPE™ medical system testing apparatus. Research subjects will then be released after survey. A follow-up telephone call at 24 hours will assess any adverse events related to the experimental session. For the period of 30 days after their scheduled surgery, minor and major postoperative complications will be extracted from the electronic medical record.

Study Timeline

• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-24
• Study Start: 2023-05-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-06
• Primary Completion: 2026-05-29
• Study Completion: 2026-05-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion 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

Exclusion Criteria

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Validation Cohort	Shape II	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 \<2 on the revised cardiac risk index (RCRI) undergoing submaximal exercise testing.

Primary Outcome Measures

Name	Time	Method
Recruitment Success	0-30 days	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

Secondary Outcome Measures

Name	Time	Method
Conventional measure of metabolic equivalents (METS)	0-1 day	If conventional measures of METS (subjective METS, Duke Activity Status Index) compare favorably to the SHAPE testing performance variables.
Major postoperative outcomes	0-30 days	• 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)
Perioperative Morbidity Survey	0-30 days	• 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.

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States