Development & Validation of Preoperative Objective Physiological Evaluation (POPE)

Duke University

Status: Enrolling

Conditions: Cardiorespiratory Fitness

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05092126

Pro00108789

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

6MST VO2

Active Comparator group

Description:

Completion of 6MST exercise protocol

Treatment:

Behavioral: Exercise

DASI VO2

Active Comparator group

Description:

Completion of DASI fitness activity questionnaire

Treatment:

Behavioral: Exercise