Studies
| 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. |
Conditions
| 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. |
Keywords
| 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 |
Sponsors
| 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 |
Eligibilities
| 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 |
Designs
| Sequence: | 30397561 |
| Observational Model | Cohort |
| Time Perspective | Prospective |
Responsible Parties
| Sequence: | 28764047 |
| Responsible Party Type | Sponsor |