Development & Validation of Preoperative Objective Physiological Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-23

Study Completion Date

2026-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiorespiratory Fitness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

All subjects will be asked to complete the exercise test and the fitness questionnaire

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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6MST VO2

Completion of 6MST exercise protocol

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

Calculate oxygen consumption

DASI VO2

Completion of DASI fitness activity questionnaire

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

Calculate oxygen consumption

Interventions

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Exercise

Calculate oxygen consumption

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No