A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Individuals scheduled for elective major intrabdominal surgery or pelvic surgeries surgeries (e.g. gastrectomy, esophagectomy, pancreatectomy, radical cystectomy, radical transabdominal debulking with or without intrabdominal hyperthermic perfusion, pelvic exenteration, retroperitoneal lymph node dissections, and low anterior resection).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cardiopulmonary Exercise Testing (CPET)
Other interventionPedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Cardiopulmonary Exercise Testing (CPET)1 intervention
Trial outcomes
Primary outcomes
1
Patient Perioperative Risk
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
Time frame
Baseline + 30 days postoperatively monitoring for morbid eventsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov