Submaximal Cardiopulmonary Exercise Testing in Adults Presenting for Moderate to High-risk Surgery and Perioperative Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 992
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular events
研究概览
简要总结
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.
详细描述
Submaximal Cardiopulmonary Exercise Testing in Adults Presenting for Moderate- to High-risk Surgery and Perioperative Outcomes (SAMPO) is a single-center prospective observational cohort repository with a retrospective validation component designed to evaluate whether measures derived from brief, clinically integrated submaximal cardiopulmonary exercise testing (smCPET) are associated with perioperative outcomes in adults undergoing moderate- to high-risk noncardiac surgery. The repository is being developed in the Yale New Haven Hospital Pre-Surgical Evaluation Clinic to support systematic collection, curation, and analysis of exercise-derived physiologic data obtained during routine preoperative care, together with clinical, perioperative, and postoperative outcome data. The overall purpose is to determine whether smCPET variables can improve perioperative risk stratification, identify patients at increased risk for postoperative complications, and generate a scalable framework for future perioperative risk modeling and implementation studies.
Perioperative complications remain common after major noncardiac surgery and are associated with increased morbidity, prolonged recovery, higher readmission rates, greater resource use, and higher health care costs. Current preoperative risk assessment often relies on history, comorbidity burden, procedural risk classification, and subjective estimates of functional capacity. Although formal cardiopulmonary exercise testing has demonstrated value for perioperative prognostication, broad adoption has been limited by the time, personnel, technical, and infrastructure requirements of conventional maximal testing. A brief submaximal approach may offer a more pragmatic alternative in the preoperative clinic setting. Early implementation work by the investigators suggests that rapid smCPET can be integrated into routine workflow, produces technically usable data in a high proportion of patients, and may yield physiologic measures associated with early postoperative morbidity. This repository is intended to extend that work by creating a structured dataset that allows more rigorous assessment of the relationship between preoperative smCPET findings and clinically meaningful postoperative outcomes.
The central scientific premise of the repository is that preoperative physiologic response to submaximal exercise reflects cardiopulmonary reserve and integrative functional capacity in ways not fully captured by routine clinical history or conventional screening instruments. Variables such as peak oxygen uptake achieved during submaximal effort, anaerobic threshold, ventilatory efficiency, heart rate response, and slope-based exercise measures may identify latent vulnerability before surgery. If those measures show meaningful associations with early and later postoperative complications, they may support more objective risk assessment, perioperative triage, allocation of optimization resources, and selection of patients for enhanced monitoring or future interventional studies. The repository is therefore designed not merely as a passive data storage effort, but as an analytic infrastructure for validating clinically feasible physiologic markers in the perioperative setting.
The study includes a prospective component and a retrospective component. In the prospective component, adult participants undergoing routine preoperative evaluation in the Yale Pre-Surgical Evaluation Clinic who are referred for or complete smCPET as part of clinical care are approached for consent for inclusion in the repository. smCPET is not performed for research purposes; rather, the study captures data already generated during standard clinical assessment and links those data to perioperative and postoperative outcomes. The planned initial enrollment period is 36 months with follow-up extending through the perioperative period and including later outcome ascertainment. The protocol also describes an overall study duration of 48 months and a single study site.
The retrospective component consists of historical data from the period before clinical implementation of smCPET, including approximately 24 months of historical control data to support validation, comparison, matched cohort analyses, and evaluation of outcomes, costs, and resource utilization patterns. This aspect of the study is intended to contextualize the prospective findings and allow comparison between patients evaluated in the era of smCPET-enabled preoperative assessment and an earlier period without routine smCPET integration. Together, the two components create a hybrid repository structure: a prospective observational cohort of clinically evaluated patients supplemented by retrospective clinical data for validation and comparison.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Submaximal CPET guided high-risk preoperative evaluation
Patients from high-risk evaluation preoperative referrals
干预措施: Recruited participants receive preoperative rapid submaximal cardiopulmonary exercise testing within the current risk assessment framework of the pre-surgical evaluation clinic (Diagnostic Test)
结局指标
主要结局
Major adverse cardiovascular events
时间窗: 30 days
Composite Cardiovascular death, acute heart failure, cardiac arrythymias, perioperative myocardia infarction/injury in the 30 days after surgical procedure.
次要结局
- 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)
- Readmission(30 days)
- Healthcare Utilization Indicator: ICU admission duration(30 days)
研究者
Zyad Carr
Associate Professor, Department of Anesthesiology
Yale University
