Development & Validation of Preoperative Objective Physiological Evaluation

Cardiorespiratory Fitness Clinical Trial

— POPE  

Official title:

Development & Validation of Preoperative Objective Physiological Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05092126
• Other study ID #: Pro00108789
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2021
• Est. completion date: January 1, 2026

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: David MacLeod, FRCA
• Phone: 919-812-3201
• Email: david.macleod[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiorespiratory Fitness

Intervention

Behavioral:
• Exercise
Calculate oxygen consumption

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of oxygen consumed per minute	Oxygen consumption measured in mL/min	Up to 15 minutes