SHAPE Test for Preoperative Risk Stratification

NCT05743673 | Recruiting DMC FDA Device

• 1 other identifier: 2000033885
• Study Type: observational
• Target: 371
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

perioperative risk stratification; submaximal cardiopulmonary exercise testing; postoperative complications; perioperative complications

Outcome Measures

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

  0-30 days

Secondary Outcomes (3)

• Conventional measure of metabolic equivalents (METS)

  0-1 day

• Perioperative Morbidity Survey

  0-30 days

• Major postoperative outcomes

  0-30 days

Study Arms (1)

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.

Device: Shape II

Interventions

Shape II DEVICE

cardiopulmonary exercise testing apparatus

Validation Cohort

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

• Age \<60 years old
• Subjective METS \<4
• Inability to give independent informed consent
• Revised Cardiac Risk Index (RCRI) \>2
• Neurological impairment with motor limitations
• Mental impairment leading to inability to cooperate
• Recent NSTEMI or STEMI type myocardial infarction (within 6 months)
• Angina (stable or unstable, within 6 months)
• Uncorrected severe valvular heart disease (severe aortic, tricuspid, or mitral stenosis)
• Recent exacerbation of congestive heart failure (requiring hospitalization, within 6 months)
• Acute pulmonary embolism or deep vein thrombosis (within past 6 months)
• Uncontrolled pulmonary edema
• Uncontrolled symptomatic arrhythmias
• Active endocarditis
• Acute myocarditis or pericarditis

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

RECRUITING

Related Publications (16)

• Ackland GL, Abbott TEF, Minto G, Clark M, Owen T, Prabhu P, May SM, Reynolds JA, Cuthbertson BH, Wijeysundera D, Pearse RM; METS and POM-HR Study Investigators. Heart rate recovery and morbidity after noncardiac surgery: Planned secondary analysis of two prospective, multi-centre, blinded observational studies. PLoS One. 2019 Aug 21;14(8):e0221277. doi: 10.1371/journal.pone.0221277. eCollection 2019.

  PMID: 31433825 BACKGROUND

• Bennett H, Parfitt G, Davison K, Eston R. Validity of Submaximal Step Tests to Estimate Maximal Oxygen Uptake in Healthy Adults. Sports Med. 2016 May;46(5):737-50. doi: 10.1007/s40279-015-0445-1.

  PMID: 26670455 BACKGROUND

• Bernstein EJ, Mandl LA, Gordon JK, Spiera RF, Horn EM. Submaximal heart and pulmonary evaluation: a novel noninvasive test to identify pulmonary hypertension in patients with systemic sclerosis. Arthritis Care Res (Hoboken). 2013 Oct;65(10):1713-8. doi: 10.1002/acr.22051.

  PMID: 23740875 BACKGROUND

• Bohannon RW, Crouch RH. Two-Minute Step Test of Exercise Capacity: Systematic Review of Procedures, Performance, and Clinimetric Properties. J Geriatr Phys Ther. 2019 Apr/Jun;42(2):105-112. doi: 10.1519/JPT.0000000000000164.

  PMID: 29210933 BACKGROUND

• Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

  PMID: 7154893 BACKGROUND

• Cole CR, Blackstone EH, Pashkow FJ, Snader CE, Lauer MS. Heart-rate recovery immediately after exercise as a predictor of mortality. N Engl J Med. 1999 Oct 28;341(18):1351-7. doi: 10.1056/NEJM199910283411804.

  PMID: 10536127 BACKGROUND

• Devereaux PJ, Goldman L, Cook DJ, Gilbert K, Leslie K, Guyatt GH. Perioperative cardiac events in patients undergoing noncardiac surgery: a review of the magnitude of the problem, the pathophysiology of the events and methods to estimate and communicate risk. CMAJ. 2005 Sep 13;173(6):627-34. doi: 10.1503/cmaj.050011.

  PMID: 16157727 BACKGROUND

• Ferguson M, Shulman M. Cardiopulmonary Exercise Testing and Other Tests of Functional Capacity. Curr Anesthesiol Rep. 2022;12(1):26-33. doi: 10.1007/s40140-021-00499-6. Epub 2021 Nov 20.

  PMID: 34840532 BACKGROUND

• Gerson MC, Hurst JM, Hertzberg VS, Baughman R, Rouan GW, Ellis K. Prediction of cardiac and pulmonary complications related to elective abdominal and noncardiac thoracic surgery in geriatric patients. Am J Med. 1990 Feb;88(2):101-7. doi: 10.1016/0002-9343(90)90456-n.

  PMID: 2301435 BACKGROUND

• Grocott MP, Browne JP, Van der Meulen J, Matejowsky C, Mutch M, Hamilton MA, Levett DZ, Emberton M, Haddad FS, Mythen MG. The Postoperative Morbidity Survey was validated and used to describe morbidity after major surgery. J Clin Epidemiol. 2007 Sep;60(9):919-28. doi: 10.1016/j.jclinepi.2006.12.003. Epub 2007 May 7.

  PMID: 17689808 BACKGROUND

• Hansen D, Jacobs N, Thijs H, Dendale P, Claes N. Validation of a single-stage fixed-rate step test for the prediction of maximal oxygen uptake in healthy adults. Clin Physiol Funct Imaging. 2016 Sep;36(5):401-6. doi: 10.1111/cpf.12243. Epub 2015 Jun 5.

  PMID: 26046474 BACKGROUND

• Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989 Sep 15;64(10):651-4. doi: 10.1016/0002-9149(89)90496-7.

  PMID: 2782256 BACKGROUND

• Kallianos A, Rapti A, Tsimpoukis S, Charpidou A, Dannos I, Kainis E, Syrigos K. Cardiopulmonary exercise testing (CPET) as preoperative test before lung resection. In Vivo. 2014 Nov-Dec;28(6):1013-20.

  PMID: 25398794 BACKGROUND

• Khatri V, Neal JE, Burger CD, Lee AS. Prognostication in Pulmonary Arterial Hypertension with Submaximal Exercise Testing. Diseases. 2015 Feb 6;3(1):15-23. doi: 10.3390/diseases3010015.

  PMID: 28943605 BACKGROUND

• Carr ZJ, Charchaflieh J, Brenes-Bastos A, He H, Lin HM, Jankelovits A, Gu E, Zafar J, Ghali F, Tan WS, Heerdt P. Preoperative submaximal cardiopulmonary exercise testing and its association with early postoperative complications. BJA Open. 2025 Apr 24;14:100407. doi: 10.1016/j.bjao.2025.100407. eCollection 2025 Jun.

  PMID: 40421445 DERIVED

• Carr ZJ, Agarkov D, Li J, Charchaflieh J, Brenes-Bastos A, Freund J, Zafar J, Schonberger RB, Heerdt P. Implementation of Brief Submaximal Cardiopulmonary Testing in a High-Volume Presurgical Evaluation Clinic: Feasibility Cohort Study. JMIR Perioper Med. 2025 Feb 17;8:e65805. doi: 10.2196/65805.

  PMID: 39773953 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zyad J Carr, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zyad J Carr, M.D.

CONTACT

203-785-3689; zyad.carr@yale.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anesthesiology

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 24, 2023
• Study Start: May 3, 2023
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): May 29, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

US (1)