Preoperative Exercise Testing and Perioperative Outcomes

NCT07519733 | Recruiting

• 1 other identifier: 2000039292
• Study Type: observational
• Target: 992
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn whether results from a brief exercise test done before surgery can help identify adults who may be more likely to have problems after moderate- to high-risk noncardiac surgery. The study includes adults older than 45 years who are seen in a pre-surgical evaluation clinic and complete submaximal cardiopulmonary exercise testing, or smCPET, as part of their usual clinical care. The main questions it aims to answer are: Are smCPET measurements linked with early problems after surgery? Are smCPET measurements linked with later problems after surgery, including complications within 30 and 60 days, longer hospital stay, and death? Can smCPET add useful information to standard preoperative risk assessment? Researchers will observe and analyze information collected during routine care. No extra exercise testing or treatment will be done for research. Participants will:

• Complete routine preoperative evaluation in the Yale Pre-Surgical Evaluation Clinic.
• Undergo smCPET if it is ordered as part of standard clinical care.
• Allow researchers to collect information from the medical record and from the exercise test for the study repository, if they agree to participate. The study will collect de-identified information about each participant's health before surgery, exercise test results, details about the surgery and hospital stay, and problems that happen after surgery. This may include age, sex, body mass index, other medical conditions, routine lab and imaging results, heart rate, blood pressure, oxygen levels, smCPET measures such as peak oxygen uptake, anaerobic threshold, and breathing efficiency, and early and late postoperative outcomes. Researchers will look at short-term and later outcomes after surgery. These include problems identified during the hospital stay, such as heart, lung, kidney, nerve, blood, wound, and pain-related complications, as well as complications within 30 and 60 days after surgery. Researchers will also study hospital length of stay and death after surgery. This study is designed to help researchers understand whether a short, practical exercise test can improve the way surgical risk is assessed before an operation. Current preoperative assessment tools do not always measure how well the heart, lungs, and muscles work together during physical stress. smCPET may provide a more objective way to measure functional capacity and physiologic reserve in a busy clinic setting. This is a single-center study based in a preoperative evaluation clinic. The study has a prospective observational cohort component and a retrospective validation component. In the prospective part, adults who meet clinic criteria and complete smCPET during routine care may be asked to join the repository. In the retrospective part, researchers may also review historical data from patients evaluated before smCPET was put into routine use to help compare outcomes and validate findings. Because this is an observational repository study, participation does not change the care participants receive. The exercise test is done for clinical reasons, not because of the research study. The research team will not assign treatments or decide what surgery a participant has. Instead, the team will study how exercise test findings relate to outcomes that occur after surgery. The long-term aim of this study is to improve preoperative risk assessment and help clinicians better identify patients who may need closer monitoring, more evaluation, or more support around the time of surgery. If the findings are useful, they may support broader use of brief preoperative exercise testing in adults having higher-risk noncardiac surgery.

Conditions

Postoperative Complications (Cardiopulmonary)

Keywords

preoperative evaluation; submaximal cardiopulmonary exercise testing; major adverse cardiovascular events; preoperative risk stratification; high risk evaluation

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events

  Composite Cardiovascular death, acute heart failure, cardiac arrythymias, perioperative myocardia infarction/injury in the 30 days after surgical procedure.

  30 days

Secondary Outcomes (7)

• Early Postoperative Complications

  5 days

• Early Neurological Outcomes (Confusion Assessment Method (CMA) for the ICU-7 Delirium Severity Scale (CAM-ICU))

  Up to 5 days after surgical procedure; 0-5 scale (0=absent, 5=severe delirium)

• Early Renal Outcomes

  Postoperative Day 0-5

• Surgical Site Infection

  30 days

• Postoperative functional recovery (patient-centered outcome)

  30 days

Other Outcomes (5)

• Intraoperative hemodynamic stability

  Intraoperative time period

• Healthcare Utilization Indicator (Length of Stay)

  up to 30 days

• Cost effectiveness Analysis

  30 days

Study Arms (1)

Submaximal CPET guided high-risk preoperative evaluation

Patients from high-risk evaluation preoperative referrals

Diagnostic Test: Recruited participants receive preoperative rapid submaximal cardiopulmonary exercise testing within the current risk assessment framework of the pre-surgical evaluation clinic

Interventions

Recruited participants receive preoperative rapid submaximal cardiopulmonary exercise testing within the current risk assessment framework of the pre-surgical evaluation clinic DIAGNOSTIC_TEST

A six minute submaximal cardiopulmonary exercise test that is used to identify cardiopulmonary abnormalities associated with heart and lung disease. This seeks to aid the physician in prescribing preoperative interventions to reduce postoperative cardiopulmonary complications.

Also known as: submaximal cardiopulmonary exercise testing

Submaximal CPET guided high-risk preoperative evaluation

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The pool of participants for enrollment in this data repository will be patients that have met criteria for preoperative smCPET screening with EITHER a * Modified Duke Activity Status Index9 score of \<3 or Duke Activity Status Index \< or = 34 * A surgeon's request for preoperative evaluation to assess fitness for surgery * An anesthesiologist request for preoperative evaluation to assess fitness for surgery. * A consulting physician request for preoperative evaluation to assess fitness for surgery. * Or a revised cardiac risk index10 of \>2 with moderate to high risk features (coronary artery disease, cardiomyopathy, echocardiography with reduced ejection fraction, myocardial infarction w/in prior 12 months (but \>6 weeks from scheduled surgery).

You may qualify if:

• greater than 45 years old
• moderate to high-risk noncardiac surgery
• surgeon, anesthesiologist or other medical provider requested referral for preoperative high risk evaluation, or
• revised cardiac risk index \> or = 2, or
• Ambiguous, low or discordant functional capacity by either the Duke Activity status index (DASI \<34) or the modified Duke Activity status index (\< or =3) or
• Frailty Index \>1

You may not qualify if:

• Age \<45
• Absolute contraindication to submaximal cardiopulmonary exercise testing
• Impaired decision making capacity
• Prisoners
• Pregnancy
• Severe peripheral vascular disease
• Functional limitation precluding the performance of submaximal cardipulmonary exercise testing
• Severe active pulmonary disease

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital, Pre-Surgical Evaluation Clinic

New Haven, Connecticut, 06520, United States

RECRUITING

Related Publications (6)

• 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 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 BACKGROUND

• Snowden CP, Prentis JM, Anderson HL, Roberts DR, Randles D, Renton M, Manas DM. Submaximal cardiopulmonary exercise testing predicts complications and hospital length of stay in patients undergoing major elective surgery. Ann Surg. 2010 Mar;251(3):535-41. doi: 10.1097/SLA.0b013e3181cf811d.

  PMID: 20134313 BACKGROUND

• Older P, Hall A, Hader R. Cardiopulmonary exercise testing as a screening test for perioperative management of major surgery in the elderly. Chest. 1999 Aug;116(2):355-62. doi: 10.1378/chest.116.2.355.

  PMID: 10453862 BACKGROUND

• Wijeysundera DN, Pearse RM, Shulman MA, Abbott TEF, Torres E, Ambosta A, Croal BL, Granton JT, Thorpe KE, Grocott MPW, Farrington C, Myles PS, Cuthbertson BH; METS study investigators. Assessment of functional capacity before major non-cardiac surgery: an international, prospective cohort study. Lancet. 2018 Jun 30;391(10140):2631-2640. doi: 10.1016/S0140-6736(18)31131-0.

  PMID: 30070222 BACKGROUND

• Beckerleg W, Kobewka D, Wijeysundera DN, Sood MM, McIsaac DI. Association of Preoperative Medical Consultation With Reduction in Adverse Postoperative Outcomes and Use of Processes of Care Among Residents of Ontario, Canada. JAMA Intern Med. 2023 May 1;183(5):470-478. doi: 10.1001/jamainternmed.2023.0325.

  PMID: 36972037 BACKGROUND

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: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anesthesiology

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 9, 2026
• Study Start: July 23, 2025
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: January 1, 2028 - January 1, 2030
• Access Criteria: De-identified individual participant data will be made available only to qualified investigators upon reasonable request and after approval by the Principal Investigator or repository oversight group. Investigators must submit a written proposal describing the research question, analytic plan, institutional affiliation, and applicable ethics oversight. Approved requestors will receive access only to the minimum necessary de-identified dataset required to address the approved aims. Supporting materials, including the protocol, data dictionary, variable definitions, and analytic code where available, may also be provided. Access will be contingent upon execution of a data use agreement prohibiting re-identification, unauthorized sharing, and use outside the approved scope. Data will be shared using secure, institutionally approved transfer or controlled-access mechanisms.

Locations

US (1)