Clinical trial · Observational
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
NCT00493688CI-TRIAL-00118012recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To validate a new method for assessing perioperative risk in the cancer patient undergoing major cancer surgery. In this proposed study researchers will: 1. Measure preoperative energy reserve capacity (fitness) 2. Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Cancer | Malignant Abdominal Neoplasm | ALIAS | 0.90 |
| Pelvic Cancer | Malignant Pelvic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiopulmonary Exercise Testing (CPET) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cardiopulmonary Exercise Testing (CPET)
- interventionNames
- Other: Cardiopulmonary Exercise Testing (CPET)
Primary outcomes (1)
- measure
- Patient Perioperative Risk
- timeFrame
- Baseline + 30 days postoperatively monitoring for morbid events
- description
- Measure preoperative energy reserve capacity (fitness) using perioperative energy dynamics where fitness is defined by gas exchange data during cardiopulmonary exercise testing as method of assessing perioperative risk
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants 18 years of age or older. * Participants with newly diagnosed esophageal and lung cancer undergoing neoadjuvant chemotherapy, radiation therapy, and/or immunotherapy. * Participants who have signed the consent form to participate in the study. * Participants must have been evaluated in the Perioperative Evaluation and Management (POEM) Center or by a staff Anesthesiologist. * All laboratory and diagnostic evaluations required or used to evaluate the patient must be completed. All participants must be approved to undergo anesthesia by the standards of the POEM Center. * No samples belonging to vulnerable populations (children, pregnant women, cognitively impaired adults or prisoners) will be allowed from participation. Exclusion Criteria: * Participant is under age 18. * Participant is unwilling to sign consent. * Participant is unable to exercise (bedridden or wheel chair bound). * Participant is enrolled in another study deemed by the investigator to affect oxygen metabolic efficiency and not presently the standard of care at MDACC. * Participant's condition is deemed unsatisfactory for surgery after the preanesthetic evaluation. * Participant has had a myocardial infarction within three months of the preanesthetic evaluation or presents with new or unstable angina. * Participant has a history of a cerebrovascular accident or transit ischemic attacks within three months of the preanesthetic evaluation. * Participant has a history of a pulmonary embolic event within three months of the preanesthetic evaluation. * Participant is known to have acute or chronic deep vein thrombosis. * Participant is pregnant.
References
Publications (0)
Data not yet available
No reference posted for this study.