Development & Validation of Preoperative Objective Physiological Evaluation (POPE)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiorespiratory Fitness
• Intervention / Treatment: Behavioral: Exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David MacLeod, FRCA; Phone Number: 919-812-3201; Email: david.macleod@duke.edu
• Study Contact Backup: Name: Ashley Burke, BS

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Health System
      • Contact: David B MacLeod, FRCA; Phone Number: 919-812-3201; Email: david.macleod@duke.edu
      • Principal Investigator: David B MacLeod, FRCA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 6MST VO2; Completion of 6MST exercise protocol	Behavioral: Exercise; Calculate oxygen consumption
Active Comparator: DASI VO2; Completion of DASI fitness activity questionnaire	Behavioral: Exercise; Calculate oxygen consumption

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of oxygen consumed per minute	Oxygen consumption measured in mL/min	Up to 15 minutes

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: David MacLeod, FRCA, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; exercise capacity; functional capacity; cardiopulmonary exercise testing; areobic power
• Other Study ID Numbers: Pro00108789

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No