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Search / Trial NCT05092126

Development & Validation of Preoperative Objective Physiological Evaluation

Launched by DUKE UNIVERSITY · Oct 12, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Areobic Power Cardiopulmonary Exercise Testing Exercise Capacity Functional Capacity Physical Activity

ClinConnect Summary

This clinical trial is studying how well we can measure a person’s fitness before surgery by comparing two methods: one that involves a simple exercise test to measure oxygen consumption (VO2) and another that uses a questionnaire about physical activity. The goal is to see if the questionnaire can reliably estimate a patient’s fitness level, which is important for planning safe surgeries.

To join this study, participants need to be at least 18 years old, able to speak English, and can walk with or without help. They should be scheduled for a preoperative assessment and have a specific score on a fitness questionnaire. However, people with certain health issues, like recent heart problems or severe high blood pressure, can't participate. If you join, you can expect to do a short exercise test and answer some questions about your physical activity. This study is an important step in improving how we assess patients' fitness before surgery, which can help ensure safer surgical experiences.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age 18 and older
  • Able to speak English
  • Ambulatory \[assistive devices ok\]
  • Preoperative Anesthesia and Surgical Screening (PASS) clinic patient with DASI score \<34
  • Able to provide informed consent
  • Exclusion Criteria:
  • Acute myocardial infarction (3-5 days)
  • Unstable angina
  • Severe untreated arterial hypertension at rest (\>200 mm Hg systolic, \>120 mm Hg diastolic)
  • Resting heart rate \> 120 bpm
  • Room air desaturation at rest on room air \<85%
  • Inmate of correctional facility (i.e. prisoner)
  • Diagnosed history of dementia
  • Inability to ambulate independently
  • Considered inappropriate to participate by Principal Investigator

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

David MacLeod, FRCA

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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