Development & Validation of Preoperative Objective Physiological Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise.
- Who it may be relevant to
- Registry conditions: Cardiorespiratory Fitness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Exercise
Calculate oxygen consumption
Primary outcome measures
- Total amount of oxygen consumed per minute [Time frame: Up to 15 minutes]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Duke University Health System — Durham
Identifiers
NCT: NCT05092126 · Pro00108789