Status:
COMPLETED
Effect of Diaphragm Stimulation During Surgery
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institutes of Health (NIH)
University of Arizona
Conditions:
Mechanical Ventilation Complication
Diaphragm Injury
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
During major surgical procedures general anesthesia is used to make the patient unconscious. General anesthesia insures that the patient is unaware of any pain caused by surgery. General anesthesia al...
Detailed Description
Although mechanical ventilation (MV) is life-sustaining, it comes with a cost. MV dramatically reduces diaphragm contractility, induces ventilator-induced diaphragm dysfunction (VIDD) and sometimes le...
Eligibility Criteria
Inclusion
- Patients undergoing complex, elective prolonged surgeries, usually lasting 5-8 hours or longer, including lung transplants (e.g. valveoplasty, coronary artery bypass and/or aortic repairs)
Exclusion
- history of prior surgery to the diaphragm or pleura;
- a diagnosis of COPD will be determined from a clinical history consistent with chronic bronchitis and/or emphysema, a long history of cigarette smoking, and pulmonary function tests consistent with irreversible airflow obstruction (FEV1 \< 40% predicted, according to European Respiratory Society criteria \[will not apply to transplant patients\]
- a diagnosis of chronic heart failure (NYHA class IV)
- clinical diagnosis of other lung disease (cystic fibrosis, bronchiectasis, lung cancer; etc.) \[will not apply to transplant patients\]
- renal insufficiency (serum creatinine \> 1.6 mg/dl);
- severe hepatic disease (any liver function tests \> 1.5 times the upper limit of normal);
- undernourishment (body mass index \< 20 kg/m2),
- chronic uncontrolled or poorly controlled metabolic diseases (e.g., diabetes, hypo- or hyperthyroidism)
- orthopedic diseases, suspected paraneoplastic or myopathic syndromes,
- if in the surgeons' judgment the patients' clinical status warrants, diaphragm stimulation will be stopped and biopsies will not be obtained,
Key Trial Info
Start Date :
February 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03303040
Start Date
February 14 2018
End Date
December 31 2023
Last Update
June 26 2024
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610