Phase
Condition
N/ATreatment
pdSTIM System Therapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is 18 years or older.
Subject, or subject's Legally Authorized Representative, understands studyrequirements, study visits, and is willing and able to provide written informedconsent prior to study specific procedures or testing.
Subject has been on mechanical ventilation for ≥ 96 hours prior to randomization (intubation or tracheostomy).
Subject has failed at least 1 weaning attempt (e.g., site directed spontaneousbreathing trial(s) did not result in liberation).
At the time of enrollment, the subject is likely to be ventilated for an additional 48 hours, at minimum, in the opinion of the investigator.
Exclusion
Exclusion Criteria:
Subject has been on invasive mechanical ventilation for > 45 days.
Subject failed to wean due to pre-existing neurological or neuromuscular issuesaffecting the respiratory muscles (e.g., ALS, phrenic nerve paralysis, inflammatorymuscle disease, underlying myopathy, myasthenia gravis, cervical spinal injury).
Subject's medical history, known anatomy or investigator's inability to visualizenecessary anatomical landmarks that could prevent the safe placement of the pdSTIMleads.
Subject is at risk of significant hemorrhage or is currently receiving a full doseof systemic anticoagulation (e.g., IV heparin, high dose of subcutaneous heparin.Subjects on prophylactic anticoagulation or daily aspirin regimen on their own arenot excluded unless other exclusion criteria apply).
Subject has an implant or external electrical device that may interact or interferewith the pdSTIM System (examples may include cardiac pacemaker, implantabledefibrillator, vagal nerve stimulator, spinal cord stimulator, gastric stimulator,diaphragmatic stimulator).
Subject has been diagnosed and has been treated for neck cancer within the past 5years or subject had any prior radiation treatment to the neck.
Subject currently has hemodynamic instability due to any cause (e.g., severe sepsis,hemorrhagic shock, or septic shock) with vasopressor support > 0.1 mg/kg/min ofnorepinephrine or epinephrine, or equivalent, or is actively being titrated.
Subject has a local infection at or around the proposed pdSTIM Lead insertion site.
Subject is neutropenic or has signs of significant immunocompromise. (Subjectsintubated for respiratory failure due to COVID-19 are not excluded unless otherexclusion criteria apply).
Subject has severe COPD as indicated by evidence of significant expiratoryobstruction on the ventilator flow waveform or, where ventilator flow waveforms arenot utilized, has a FEV1 ≤ 30%.
Subject has pre-existing severe chronic pulmonary fibrosis.
Subject has pleural effusion occupying greater than 1/3 of the pleural space oneither side.
Subject is currently on or expected to begin neuromuscular blockades.
Subject is anticipating withdrawal of life support and/or shift to palliation as thegoal of care with less than 6-months life expectancy.
Subject is known or suspected to be pregnant or lactating.
Subject is currently enrolled in or exited early from a) any investigational drugstudy or b) an investigational device study that may impact the ability to wean oris directly related to the lungs or diaphragm.
Study Design
Study Description
Connect with a study center
University of South Alabama
Mobile, Alabama 36617
United StatesActive - Recruiting
Chandler Regional Medical Center
Chandler, Arizona 85224
United StatesActive - Recruiting
Abrazo West Health
Goodyear, Arizona 85395
United StatesActive - Recruiting
HonorHealth Research Institute
Scottsdale, Arizona 85260
United StatesActive - Recruiting
Northeast Georgia Medical Center
Gainesville, Georgia 30501
United StatesActive - Recruiting
University of Illinois Chicago
Chicago, Illinois 60612
United StatesActive - Recruiting
RML Specialty Hospital
Hinsdale, Illinois 60521
United StatesActive - Recruiting
University of Louisville
Louisville, Kentucky 40202
United StatesActive - Recruiting
Tulane University Medical Center
New Orleans, Louisiana 70112
United StatesActive - Recruiting
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana 71103
United StatesActive - Recruiting
University of Michigan Health - West
Wyoming, Michigan 49519
United StatesActive - Recruiting
Bryan Medical Center
Lincoln, Nebraska 68506
United StatesSite Not Available
Northwell South Shore University Hospital
Bay Shore, New York 11706
United StatesActive - Recruiting
University at Buffalo
Buffalo, New York 14203
United StatesActive - Recruiting
Atrium Health
Charlotte, North Carolina 28203
United StatesActive - Recruiting
WakeMed Health
Raleigh, North Carolina 27610
United StatesActive - Recruiting
Forsyth Medical Center
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
Baptist Clinical Research Institute, Inc.
Memphis, Tennessee 38120
United StatesActive - Recruiting
St. David's Healthcare
Georgetown, Texas 78626
United StatesActive - Recruiting
Houston Methodist
Houston, Texas 77030
United StatesActive - Recruiting
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