N/A N=25 Prevention

Effect of Diaphragm Stimulation During Surgery

Mechanical Ventilation Complication · Diaphragm Injury

Bottom Line

View on ClinicalTrials.gov: NCT03303040 ↗

Enrolled (actual)

Serious AEs

66.7%

Results posted

May 2024

Primary outcome: Primary: Mitochondrial Respiration — 3.5; 2.9; 31.1; 27.1 pmol/s/mg wwt

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Electrical stimulation of hemidiaphragm (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Mitochondrial Respiration	3.5; 2.9; 31.1; 27.1	—
PRIMARY Aconitase Activity	0.175; 0.196	—
PRIMARY Lipid Peroxidation	1.037; 1.061	—
PRIMARY Citrate Cynthase Activity	0.084; 0.082	—
PRIMARY Single Diaphragm Fiber, Specific Force	102.64; 95.85; 124.5; 126.93	—
PRIMARY Single Diaphragm Fiber, Rate of Tension Redevelopment	1.102; 1.143; 4.744; 4.777	—
PRIMARY Calcium Sensitivity (pCa50)	5.805; 5.797; 5.888; 5.887	—
PRIMARY Difference in Total Titin to Myosin Heavy Chain Ratio	0.111; 0.103	—
PRIMARY Difference in Titin Exon Composition	96.1; 96.3; 3.9; 3.7	—
PRIMARY Difference in Titin Binding Protein Content	0.0165; 0.0167; 1.39; 1.28	—
PRIMARY Difference in Calpain 1 Protein Content	74; 72.4; 14.1; 15	—
PRIMARY Difference in Calpain 2 Protein Content	274938; 357182	—
PRIMARY Difference in Calpain 3 Protein Content	2.98; 3.21	—
PRIMARY Difference in Caspase-3 Protein Content	274328; 317726	—
PRIMARY Atrogin 1	634046; 675965	—

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 also prevents the patient from moving to prevent any potential surgical error. At the same time general anesthesia makes it impossible for the patient to breathe. To help the patient breathe a breathing tube is placed into the patient's airway and connected to the mechanical ventilator. A mechanical ventilator is an artificial breathing pump, which delivers gas into a patient's airways. The purpose of this research study is to determine if brief periods of diaphragm stimulation can prevent diaphragm problems caused by the use of mechanical ventilators and surgery. To answer this question the changes in the genes responsible for maintaining diaphragm function will be studied. A gene is the code present in each cell in your body and controls the behavior of that cell. In addition, the changes in the contractile properties of muscle fibers will be studied. The results from this study may help develop new treatments to prevent diaphragm weakness resulting from mechanical ventilation use.

Eligibility Criteria

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 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,

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03303040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.