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Recruiting

NCT Number: NCT05092126

Development & Validation of Preoperative Objective Physiological Evaluation

This study will compare the measured oxygen consumption (VO2) obtained during sub-maximal exercise testing with the estimated VO2 derived from a non-exercise questionnaire.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

David B MacLeod, FRCA

CONTACT

[email protected]

919-812-3201

David B MacLeod, FRCA

PRINCIPAL_INVESTIGATOR

About this study

All surgical patients presenting at the Preoperative Anesthesia & Surgical Screening (PASS Clinic) will complete the Duke Activity Status Index (DASI) self-reported questionnaire as standard of care. If the DASI score is 34 or greater, the patients will not be considered for the study. If the DASI score is 33 or lower, the patient will be considered as a potential study participant. Eligible study participants will then complete a sub-maximal exercise test (Six Minute Step Test, 6MST) with measured VO2.

The VO2 is an integral part of preoperative assessment of cardiorespiratory fitness (CRF). A low CRF is associated with a higher incidence of post-operative complications and mortality. The study will evaluate the ability to estimate VO2 from exercise-derived measurement with questionnaire-derived estimation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Calculate oxygen consumption

Primary outcomes

  1. Total amount of oxygen consumed per minute

    Time frame: Up to 15 minutes

    Oxygen consumption measured in mL/min

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Burke, BS

CONTACT

David MacLeod, FRCA

CONTACT

[email protected]

919-812-3201

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: POPE

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Oct 25, 2021
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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