POM-MP: PeriOp Metabolic & Mitochondrial Phenotype


Study First Submitted Date 2021-04-27
Study First Posted Date 2021-04-29
Last Update Posted Date 2023-07-03
Start Month Year October 2023
Primary Completion Month Year June 2024
Verification Month Year June 2023
Verification Date 2023-06-30
Last Update Posted Date 2023-07-03

Detailed Descriptions

Sequence: 20646376
Description Cardiorespiratory fitness (CRF) is a measure of the efficiency to use oxygen. One method used to measure CRF is the cardiopulmonary exercise test (CPET), otherwise known as 'VO2 max'. Previous studies have shown that individuals assessed with CPET-derived parameters, such as VO2 max or anaerobic threshold (AT), below specific thresholds are at greater risk of post-operative complications, which can occur in up to 40% of surgical patients. This study wants to determine if other methods of fitness or well-being, such as mitochondrial oxygen consumption and muscle ultrasound to determine muscle characteristics, can be combined with CPET assessment to improve the ability to identify surgical patients who develop postoperative complications, as measured by the validated tool, POMS. The objective of the study is to create a method to identify the metabolic and mitochondrial phenotype of the perioperative patient, termed the POM-MP.


Sequence: 51975993 Sequence: 51975994 Sequence: 51975995
Name Surgical Complications From Surgery Name Surgical Complications From Bladder Surgery Name Surgical Complications From Bowel Surgery
Downcase Name surgical complications from surgery Downcase Name surgical complications from bladder surgery Downcase Name surgical complications from bowel surgery

Id Information

Sequence: 40006728
Id Source org_study_id
Id Value Pro00108362

Design Groups

Sequence: 55377439
Title High-risk colon or bladder surgical patients
Description Patients who are diagnosed with colon or bladder cancer requiring surgical resection.


Sequence: 79561957 Sequence: 79561958 Sequence: 79561959
Name Surgery Name Complication Name Preoperative
Downcase Name surgery Downcase Name complication Downcase Name preoperative

Design Outcomes

Sequence: 176684708 Sequence: 176684709 Sequence: 176684710 Sequence: 176684711
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary
Measure Number of participants with post-operative complications as measured by Postoperative Morbidity Survey (POMS) Measure Change in the highest oxygen consumption (VO2 peak) as measured by wearable face mask Measure Change in MuscleSound %iMAT as measured by portable ultrasound Measure Change in mitochondrial oxygen consumption as measured by blood analysis
Time Frame Up to 30 days post-op Time Frame Baseline (preop) and Post-op (up to 30 days) Time Frame Baseline (preop), postop Days 0, 1, 3 & 5, and Post-op (up to 30 days) Time Frame Baseline (preop), postop Days 0, 1, 3 & 5, and Post-op (up to 30 days)
Description Nine-domain tool used to assess the presence (or absence) of clinically significant changes using specified criteria. Confirmation of yes in any domain represents post-operative morbidity. Description Measured in milliliters of oxygen per min Description The parameter is derived using a proprietary algorithm applied to the ultrasound image to estimate the amount of intramuscular adipose tissue, presented as percentage Description The change between baseline and maximal oxygen consumption when maximum induced by additon of chemicals in vivo


Sequence: 48136384
Agency Class OTHER
Lead Or Collaborator lead
Name Duke University

Overall Officials

Sequence: 29173566
Role Principal Investigator
Name David B MacLeod, FRCA
Affiliation Duke University


Sequence: 30650690
Sampling Method Non-Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Population Surgical patients identified in surgical clinic as candidates for bladder or bowel resection.
Criteria Inclusion Criteria: Adults aged >18 undergoing bladder or bowel resection Able to speak English Ambulatory (assistive devices OK) Able to consent Willing to perform Cardiopulmonary Exercise Testing Exclusion Criteria: Unable to perform CPET Pregnant Prisoner Patients with diagnosed Dementia Unable to ambulate independently
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254253639
Registered In Calendar Year 2021
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 4


Sequence: 30397561
Observational Model Cohort
Time Perspective Prospective

Responsible Parties

Sequence: 28764047
Responsible Party Type Sponsor