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CompletedNCT03303040Updated Jun 26, 2024Results posted

Effect of Diaphragm Stimulation During Surgery

An interventional study of Electrical stimulation of hemidiaphragm in Mechanical Ventilation Complication and Diaphragm Injury, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-06-26.

Sponsored by University of Florida · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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 leads to weaning failure. VIDD includes reduced mitochondrial respiration and increased oxidative stress, muscle fiber damage and decreased diaphragm force production.

In animal models, intermittent diaphragm contraction during MV support attenuates VIDD. However, there are only limited data addressing this problem in humans. Here, the study team propose to directly test the hypothesis that intermittent electrical stimulation (ES) of the human hemidiaphragm during prolonged cardiac surgeries with MV support prevents/attenuates VIDD in the active hemidiaphragm. Mitochondrial function is central to energy metabolism and skeletal muscle function in a chronically active muscle, such as the diaphragm. Although abnormal mitochondrial function is thought to precipitate VIDD in animal models, limited data are available concerning mitochondrial contributions to VIDD in humans. Of even greater importance, there are no interventions available to attenuate these defects in humans. Here, the study team will test the impact of an innovative experimental treatment, intermittent electrical stimulation (ES) of the hemidiaphragm during prolonged surgeries with MV, on mitochondrial function, single fiber contractile properties and catabolic muscle pathways in human diaphragm. Using a within-subjects experimental design, muscle samples from a stimulated hemidiaphragms will be compared with samples from the unstimulated hemidiaphragm. The study team will investigate mitochondrial dysfunction and oxidative stress during prolonged CTS/MV, and the potential of ES to attenuate or prevent VIDD. Next, the study team will investigate the effects of ES on single fiber contractile properties and Titin integrity. Finally, the study team will study the effect of ES on proteolytic pathways (caspase, calpain and ubiquitin-proteasome) and ribosomal RNA markers of decreased protein synthesis implicated in VIDD.

02

Conditions studied

  • Mechanical Ventilation Complication
  • Diaphragm Injury

Keywords

  • Mechanical ventilation
  • Diaphragm weakness
  • Difficulty weaning from mechanical ventilation
  • Diaphragm stimulation
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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,
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Stimulation

    Electrical stimulation of hemidiaphragm

    Other: Electrical stimulation of hemidiaphragm

  • No intervention
    Control

    No stimulation of hemidiaphragm

Interventions

  • OtherElectrical stimulation of hemidiaphragm

    Electrical impulses

05

What researchers measure

Primary outcomes

  1. Mitochondrial Respiration

    High-resolution respirometry will be used to assess mitochondrial respiration of permeablilized diaphragm bundles. Addition of substrate medium to the Oroboros O2K respirometry instrument enables quantification of leak respiration and peak uncoupled respiration, expressed as pmol oxygen/sec/mg wet weight.

    Time frame: Up to eight hours

  2. Aconitase Activity

    In order to evaluate mitochondrial damage, actonitase activity will be measured spectrophotometrically. It will be quantified as units/mg protein.

    Time frame: Up to eight hours

  3. Lipid Peroxidation

    Lipid peroxidation will be assessed by measuring 4-hydroxy-2-nonenal-modified proteins. It will be quantified as arbitrary optical density units.

    Time frame: Up to eight hours

  4. Citrate Cynthase Activity

    Changes in electron transport chain will be assessed by measuring citrate cynthase activity. It will be quantified as nmol/mg protein/min.

    Time frame: Up to eight hours

  5. Single Diaphragm Fiber, Specific Force

    Specific force of single diaphragm fibers represents the force generated per unit area.

    Time frame: Up to eight hours

  6. Single Diaphragm Fiber, Rate of Tension Redevelopment

    Single diaphragm fiber mechanical force properties will be measured. The rate of tension redevelopment is quantified as s\^(-1).

    Time frame: Up to eight hours

  7. Calcium Sensitivity (pCa50)

    The pCa50 value is the logarithmic scale of pCa (sensitivity of Ca+2) at which half-maximal force generation was obtained. The pCa value is calculated as the -log10\[Ca (nm)\]; the pCa50 is the -log10\[Ca (nm)\] at which half-maximal force is generated.

    Time frame: Up to eight hours

  8. Difference in Total Titin to Myosin Heavy Chain Ratio

    The quantities of total titin protein and myosin heavy chain protein content in homogenized diaphragm fiber specimens were measured and then calculated as a ratio of total titin to myosin heavy chain content (unitless value). The statistical approach was selected apriori as the difference of the ratio between the stimulated and unstimulated sides.

    Time frame: Up to eight hours

  9. Difference in Titin Exon Composition

    The composition of titin exons will be assessed and quantified via real-time polymerase chain reaction (qPCR). The N2A and tT2 will be calculated as a percentage of total titin.

    Time frame: Up to eight hours

  10. Difference in Titin Binding Protein Content

    The content of titin binding proteins will be quantified via Western blot. It will be normalized to a reference protein (GAPDH) and presented as optical intensity (AU).

    Time frame: Up to eight hours

  11. Difference in Calpain 1 Protein Content

    Calpain 1 (mu-calpain) will be measured with Western Blot analysis and will be presented as percent of total intensity in stimulated and unstimulated hemidiaphragms

    Time frame: Up to eight hours

  12. Difference in Calpain 2 Protein Content

    Calpain 2 will be measured with automated, capillary-based immunoassay using a Jess System, normalized to total protein, and will be presented as an area of corrected peak (AU) in stimulated and unstimulated hemidiaphragms.

    Time frame: Up to eight hours

  13. Difference in Calpain 3 Protein Content

    Calpain 3 will be measured with Western Blot analysis and will be presented as a ratio of cleaved to total calpain 3 (unitless value) in stimulated and unstimulated hemidiaphragms.

    Time frame: Up to eight hours

  14. Difference in Caspase-3 Protein Content

    Caspase-3 will be measured with Western Blot analysis, normalized to total protein loaded in each lane, and will be presented as an area of corrected peak (AU) in stimulated and unstimulated hemidiaphragm muscle fibers.

    Time frame: Up to eight hours

  15. Atrogin 1

    Atrogin 1 will be measured with Jess protein immunoassay analysis, normalized to total protein, and will be presented as the corrected peak area (AU) in stimulated and unstimulated hemidiaphragm muscle fibers.

    Time frame: Up to eight hours

Other outcomes

  1. Mitochondrial Reactive Oxygen Species Production

    Mitochondrial reactive oxygen species (ROS) production will be assessed using an in situ approach to measure hydrogen peroxide production in permeabilized diaphragm skeletal muscle fiber bundles. It will be quantified as pmol/min/mg dry weight.

    Time frame: Up to eight hours

  2. Cytochrome c Oxidase (COX) Activity

    Changes in electron transport chain will be assessed by measuring cytochrome c oxidase (COX) activity. It will be quantifed as Units/mcg protein.

    Time frame: Up to eight hours

  3. Nuclear DNA Mutation Frequency

    Long-Amplicon quantitative PCR will be used to measure the frequency of nuclear DNA mutations. It will be quantified as number of lesions/10 kilobases.

    Time frame: Up to eight hours

  4. Titin Size

    Titin integrity will be assessed. A relative titin size will be quantified in nm.

    Time frame: Up to eight hours

  5. Caspase-9

    Caspase-9 will be measured with Western Blot anaylsis and will be presented as percent difference in expression.

    Time frame: Up to eight hours

  6. 20S Proteasome

    20S proteasome will be measured with Western Blot anaylsis and will be presented as percent difference in expression.

    Time frame: Up to eight hours

  7. 26S Proteasome

    26S proteasome will be measured with Western Blot anaylsis and will be presented as percent difference in expression.

    Time frame: Up to eight hours

  8. 28SrRNA

    28SrRNA will be measured with Western Blot anaylsis and will be presented as percent difference in expression.

    Time frame: Up to eight hours

  9. 18SrRNA

    18SrRNA will be measured with Western Blot anaylsis and will be presented as percent difference in expression.

    Time frame: Up to eight hours

  10. Foxo-3

    Foxo-3 will be measured with Western Blot anaylsis and will be presented as percent difference in expression.

    Time frame: Up to eight hours

  11. 45S Pre-rRNA

    45S pre-rRNA will be measured with Western Blot anaylsis and will be presented as percent difference in expression.

    Time frame: Up to eight hours

  12. Mitochondrial DNA Mutation Frequency

    Long-Amplicon quantitative PCR will be used to measure the frequency of mitochondrial DNA mutations. It will be quantified as number of lesions/10 kilobases.

    Time frame: Up to eight hours

  13. MurF1

    MurF1 will be measured with Western Blot anaylsis and will be presented as percent difference in expression.

    Time frame: Up to eight hours

06

Results

Posted May 30, 2024

Participant flow

Participant flow — Overall Study
MilestoneParticipants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater
Started25
Completed21
Not completed4

Outcome measures

PrimaryMitochondrial Respiration

High-resolution respirometry will be used to assess mitochondrial respiration of permeablilized diaphragm bundles. Addition of substrate medium to the Oroboros O2K respirometry instrument enables quantification of leak respiration and peak uncoupled respiration, expressed as pmol oxygen/sec/mg wet weight.

Time frame:
Up to eight hours
Reported as:
Mean · pmol/s/mg wwt
Mitochondrial Respiration
pmol/s/mg wwtControlStimulation
Leak Respiration3.5 ± 0.72.9 ± 0.6
ECI+II31.1 ± 3.527.1 ± 2.1
PrimaryAconitase Activity

In order to evaluate mitochondrial damage, actonitase activity will be measured spectrophotometrically. It will be quantified as units/mg protein.

Time frame:
Up to eight hours
Reported as:
Mean · mU/mg protein
Aconitase Activity
mU/mg proteinStimulationControl
Aconitase Activity0.175 ± 0.010.196 ± 0.01
PrimaryLipid Peroxidation

Lipid peroxidation will be assessed by measuring 4-hydroxy-2-nonenal-modified proteins. It will be quantified as arbitrary optical density units.

Time frame:
Up to eight hours
Reported as:
Mean · Arbitrary optical density units (U)
Lipid Peroxidation
Arbitrary optical density units (U)StimulationControl
Lipid Peroxidation1.037 ± 0.1451.061 ± 0.134
PrimaryCitrate Cynthase Activity

Changes in electron transport chain will be assessed by measuring citrate cynthase activity. It will be quantified as nmol/mg protein/min.

Time frame:
Up to eight hours
Reported as:
Mean · nmol/mg protein/min
Citrate Cynthase Activity
nmol/mg protein/minControlStimulation
Citrate Cynthase Activity0.084 ± 0.0060.082 ± 0.004
PrimarySingle Diaphragm Fiber, Specific Force

Specific force of single diaphragm fibers represents the force generated per unit area.

Time frame:
Up to eight hours
Reported as:
Mean · kN/m2
Single Diaphragm Fiber, Specific Force
kN/m2StimulationControl
Slow Fibers102.64 ± 2.3895.85 ± 4.62
Fast Fibers124.5 ± 2.39126.93 ± 4.3
PrimarySingle Diaphragm Fiber, Rate of Tension Redevelopment

Single diaphragm fiber mechanical force properties will be measured. The rate of tension redevelopment is quantified as s\^(-1).

Time frame:
Up to eight hours
Reported as:
Mean · per second (force recovery rate)
Single Diaphragm Fiber, Rate of Tension Redevelopment
per second (force recovery rate)StimulationControl
Slow Fibers1.102 ± 0.2691.143 ± 0.236
Fast Fibers4.744 ± 1.3224.777 ± 1.369
PrimaryCalcium Sensitivity (pCa50)

The pCa50 value is the logarithmic scale of pCa (sensitivity of Ca+2) at which half-maximal force generation was obtained. The pCa value is calculated as the -log10\[Ca (nm)\]; the pCa50 is the -log10\[Ca (nm)\] at which half-maximal force is generated.

Time frame:
Up to eight hours
Reported as:
Mean · -log10[Ca2+]
Calcium Sensitivity (pCa50)
-log10[Ca2+]StimulationControl
Slow Muscle Fibers5.805 ± 0.1585.797 ± 0.161
Fast Muscle Fibers5.888 ± 0.1155.887 ± 0.121
PrimaryDifference in Total Titin to Myosin Heavy Chain Ratio

The quantities of total titin protein and myosin heavy chain protein content in homogenized diaphragm fiber specimens were measured and then calculated as a ratio of total titin to myosin heavy chain content (unitless value). The statistical approach was selected apriori as the difference of the ratio between the stimulated and unstimulated sides.

Time frame:
Up to eight hours
Reported as:
Mean · Total titan/MHC Ratio
Difference in Total Titin to Myosin Heavy Chain Ratio
Total titan/MHC RatioControlStimulated
Difference in Total Titin to Myosin Heavy Chain Ratio0.111 ± 0.0420.103 ± 0.044
PrimaryDifference in Titin Exon Composition

The composition of titin exons will be assessed and quantified via real-time polymerase chain reaction (qPCR). The N2A and tT2 will be calculated as a percentage of total titin.

Time frame:
Up to eight hours
Reported as:
Mean · Percent of total titin
Difference in Titin Exon Composition
Percent of total titinControlStimulated
Percentage N2A96.1 ± 9.396.3 ± 6.9
Percentage tT23.9 ± 9.33.7 ± 6.9
PrimaryDifference in Titin Binding Protein Content

The content of titin binding proteins will be quantified via Western blot. It will be normalized to a reference protein (GAPDH) and presented as optical intensity (AU).

Time frame:
Up to eight hours
Reported as:
Mean · AU
Difference in Titin Binding Protein Content
AUControlStimulated
ANKRD10.0165 ± 0.02790.0167 ± 0.025
ANKRD21.39 ± 0.441.28 ± 0.52
PrimaryDifference in Calpain 1 Protein Content

Calpain 1 (mu-calpain) will be measured with Western Blot analysis and will be presented as percent of total intensity in stimulated and unstimulated hemidiaphragms

Time frame:
Up to eight hours
Reported as:
Mean · Percent of total Intensity
Difference in Calpain 1 Protein Content
Percent of total IntensityControlStimulated
Full length (80 kDa) CLP1 isoform74 ± 5.472.4 ± 5.4
Truncated (76 kDa) CLP1 isoform14.1 ± 2.615 ± 3
PrimaryDifference in Calpain 2 Protein Content

Calpain 2 will be measured with automated, capillary-based immunoassay using a Jess System, normalized to total protein, and will be presented as an area of corrected peak (AU) in stimulated and unstimulated hemidiaphragms.

Time frame:
Up to eight hours
Reported as:
Mean · AU
Difference in Calpain 2 Protein Content
AUControlStimulated
Difference in Calpain 2 Protein Content274938 ± 118636357182 ± 219400
PrimaryDifference in Calpain 3 Protein Content

Calpain 3 will be measured with Western Blot analysis and will be presented as a ratio of cleaved to total calpain 3 (unitless value) in stimulated and unstimulated hemidiaphragms.

Time frame:
Up to eight hours
Reported as:
Mean · ratio of cleaved/total calpain 3
Difference in Calpain 3 Protein Content
ratio of cleaved/total calpain 3ControlStimulated
Difference in Calpain 3 Protein Content2.98 ± 1.353.21 ± 1.9
PrimaryDifference in Caspase-3 Protein Content

Caspase-3 will be measured with Western Blot analysis, normalized to total protein loaded in each lane, and will be presented as an area of corrected peak (AU) in stimulated and unstimulated hemidiaphragm muscle fibers.

Time frame:
Up to eight hours
Reported as:
Mean · AU
Difference in Caspase-3 Protein Content
AUControlStimulated
Difference in Caspase-3 Protein Content274328 ± 70600317726 ± 164524
PrimaryAtrogin 1

Atrogin 1 will be measured with Jess protein immunoassay analysis, normalized to total protein, and will be presented as the corrected peak area (AU) in stimulated and unstimulated hemidiaphragm muscle fibers.

Time frame:
Up to eight hours
Reported as:
Mean · AU
Atrogin 1
AUControlStimulated
Atrogin 1634046 ± 377885675965 ± 379914
Other pre-specifiedMitochondrial Reactive Oxygen Species Production

Mitochondrial reactive oxygen species (ROS) production will be assessed using an in situ approach to measure hydrogen peroxide production in permeabilized diaphragm skeletal muscle fiber bundles. It will be quantified as pmol/min/mg dry weight.

Time frame:
Up to eight hours

No measurements were reported for this outcome.

Other pre-specifiedCytochrome c Oxidase (COX) Activity

Changes in electron transport chain will be assessed by measuring cytochrome c oxidase (COX) activity. It will be quantifed as Units/mcg protein.

Time frame:
Up to eight hours

No measurements were reported for this outcome.

Other pre-specifiedNuclear DNA Mutation Frequency

Long-Amplicon quantitative PCR will be used to measure the frequency of nuclear DNA mutations. It will be quantified as number of lesions/10 kilobases.

Time frame:
Up to eight hours

No measurements were reported for this outcome.

Other pre-specifiedTitin Size

Titin integrity will be assessed. A relative titin size will be quantified in nm.

Time frame:
Up to eight hours

No measurements were reported for this outcome.

Other pre-specifiedCaspase-9

Caspase-9 will be measured with Western Blot anaylsis and will be presented as percent difference in expression.

Time frame:
Up to eight hours

No measurements were reported for this outcome.

Other pre-specified20S Proteasome

20S proteasome will be measured with Western Blot anaylsis and will be presented as percent difference in expression.

Time frame:
Up to eight hours

No measurements were reported for this outcome.

Other pre-specified26S Proteasome

26S proteasome will be measured with Western Blot anaylsis and will be presented as percent difference in expression.

Time frame:
Up to eight hours

No measurements were reported for this outcome.

Other pre-specified28SrRNA

28SrRNA will be measured with Western Blot anaylsis and will be presented as percent difference in expression.

Time frame:
Up to eight hours

No measurements were reported for this outcome.

Other pre-specified18SrRNA

18SrRNA will be measured with Western Blot anaylsis and will be presented as percent difference in expression.

Time frame:
Up to eight hours

No measurements were reported for this outcome.

Other pre-specifiedFoxo-3

Foxo-3 will be measured with Western Blot anaylsis and will be presented as percent difference in expression.

Time frame:
Up to eight hours

No measurements were reported for this outcome.

Other pre-specified45S Pre-rRNA

45S pre-rRNA will be measured with Western Blot anaylsis and will be presented as percent difference in expression.

Time frame:
Up to eight hours

No measurements were reported for this outcome.

Other pre-specifiedMitochondrial DNA Mutation Frequency

Long-Amplicon quantitative PCR will be used to measure the frequency of mitochondrial DNA mutations. It will be quantified as number of lesions/10 kilobases.

Time frame:
Up to eight hours

No measurements were reported for this outcome.

Other pre-specifiedMurF1

MurF1 will be measured with Western Blot anaylsis and will be presented as percent difference in expression.

Time frame:
Up to eight hours

No measurements were reported for this outcome.

Adverse events

Collected over From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Participants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater0/21 (0%)14/21 (66.7%)21/21 (100%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventParticipants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater
ArrhythmiasCardiac disorders10/21
AnemiaBlood and lymphatic system disorders3/21
DysphagiaGeneral disorders3/21
Acute respiratory failureRespiratory, thoracic and mediastinal disorders2/21
Methycillin sensitive staph aureus infectionInfections and infestations2/21
Acute Kidney InjuryRenal and urinary disorders1/21
Acute respiratory insufficiencyRespiratory, thoracic and mediastinal disorders1/21
Near-syncopeCardiac disorders1/21
Low cardiac indexCardiac disorders1/21
Sternal wound infectionInfections and infestations1/21
Most frequent other events
Showing 10 of 14
Most frequent other events
EventParticipants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater
Postoperative PainGeneral disorders20/21
AnemiaBlood and lymphatic system disorders17/21
Pleural effusionRespiratory, thoracic and mediastinal disorders10/21
HyperglycemiaMetabolism and nutrition disorders10/21
AtelectasisRespiratory, thoracic and mediastinal disorders9/21
LeukocytosisBlood and lymphatic system disorders6/21
Acute kidney injuryRenal and urinary disorders4/21
HypotensionVascular disorders4/21
BradycardiaCardiac disorders4/21
ThrombocytopeniaBlood and lymphatic system disorders3/21

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Participants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater
<=18 years0
Between 18 and 65 years15
>=65 years6
Age, Continuous
Age, Continuous(Number)Participants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater
Mean59 ± 11.4
Sex: Female, Male
Sex: Female, Male(Participants)Participants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater
Female9
Male12
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Participants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater
Hispanic or Latino2
Not Hispanic or Latino19
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Participants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American2
White18
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Participants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater
United States21
Number of stimulations
Number of stimulations(Number of Stimulations)Participants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater
Mean6.2 ± 1.9
Stimulation Current Intensity
Stimulation Current Intensity(mA)Participants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater
Mean18.0 ± 5.4

9 further baseline measures are reported on the registry.

07

Study locations

1 site
  • University of Florida
    Gainesville, Florida 32610, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 3, 2020

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03303040
Lead sponsor
University of Florida
Collaborators
National Institutes of Health (NIH), University of Arizona, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Responsible party
Sponsor
First posted
Oct 5, 2017
Start date
Feb 14, 2018
Primary completion
May 31, 2022
Completion
Dec 31, 2023
Results posted
May 30, 2024
Last update
Jun 26, 2024

Study contacts

Anatole D Martin, PhD
principal investigator · University of Florida
Thomas M Beaver, MD
principal investigator · University of Florida
Barbara Smith, PhD, PT
principal investigator · University of Florida

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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