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POPE: Development & Validation of Preoperative Objective Physiological Evaluation

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05092126
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
11.2
Anticipated Duration (Months)
8.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
All subjects will be asked to complete the exercise test and the fitness questionnaireAll subjects will be asked to complete the exercise test and the fitness questionnaire
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Development & Validation of Preoperative Objective Physiological Evaluation
Actual Study Start Date :
Nov 23, 2021
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Total amount of oxygen consumed per minute [Up to 15 minutes]

    Oxygen consumption measured in mL/min

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Health System Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: David MacLeod, FRCA, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05092126
Other Study ID Numbers:
  • Pro00108789
First Posted:
Oct 25, 2021
Last Update Posted:
Jul 20, 2022
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Duke University
areobic power
cardiopulmonary exercise testing
exercise capacity
functional capacity
physical activity

Study Results

No Results Posted as of Jul 20, 2022