Development & Validation of Preoperative Objective Physiological Evaluation

Not Applicable

Recruiting

• Conditions: Cardiorespiratory Fitness
• Interventions: Behavioral: Exercise

• Registration Number: NCT05092126
• Lead Sponsor: Duke University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-25
• Study Start: 2021-11-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09
• Primary Completion: 2025-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
6MST VO2	Exercise	Completion of 6MST exercise protocol
DASI VO2	Exercise	Completion of DASI fitness activity questionnaire

Primary Outcome Measures

Name	Time	Method
Total amount of oxygen consumed per minute	Up to 15 minutes	Oxygen consumption measured in mL/min

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States