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Development & Validation of Preoperative Objective Physiological Evaluation

Development & Validation of Preoperative Objective Physiological Evaluation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05092126
Acronym
POPE
Enrollment
100
Registered
2021-10-25
Start date
2021-11-23
Completion date
2027-03-01
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiorespiratory Fitness

Keywords

areobic power, cardiopulmonary exercise testing, exercise capacity, functional capacity, physical activity

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALExercise

Calculate oxygen consumption

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

All subjects will be asked to complete the exercise test and the fitness questionnaire

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total amount of oxygen consumed per minuteUp to 15 minutesOxygen consumption measured in mL/min

Countries

United States

Contacts

CONTACTDavid MacLeod, FRCA
david.macleod@duke.edu919-812-3201
CONTACTAshley Burke, BS
PRINCIPAL_INVESTIGATORDavid MacLeod, FRCA

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026