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This study examines the effect of electrical stimulation of the diaphragm muscle during long, complex operations. It was designed for patients undergoing complex, elective surgeries usually lasting 5-8 hours or longer, such as lung transplants. The study was conducted as a trial without an assigned phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * 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 Criteria: * 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,