SHAPE Test for Preoperative Risk Stratification

Perioperative/Postoperative Complications Clinical Trial

— SHAPEPAT  

Official title:

A Feasibility Study of the SHAPE™ Test of Aerobic Fitness in Older Adults Presenting for Moderate to High-risk Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05743673
• Other study ID #: 2000033885
• Status: Recruiting
• Start date: May 3, 2023
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: Zyad J Carr, M.D.
• Phone: 203-785-3689
• Email: zyad.carr[@]yale.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aerobic Capacity
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Device:
• Shape II
cardiopulmonary exercise testing apparatus

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. Erratum In: PLoS One. 2019 Dec 5;14(12):e0226379. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	0-1 day
Secondary	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.	0-30 days
Secondary	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)	0-30 days