RECRUITING

Randomized Study of the pdSTIM™ System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically Ventilated Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This prospective, multi-center, randomized, controlled clinical trial is being conducted to evaluate the safety and efficacy of the pdSTIM System to facilitate weaning from mechanical ventilation through phrenic nerve stimulation. Potential subjects who are on mechanical ventilation for at least four days and have failed at least one weaning attempt will be considered for the study. Those enrolled will be randomized in a 1:1 manner between the treatment group that is standard of care with the pdSTIM System and a Control group, which is standard of care alone. The primary endpoints focus on time to weaning and serious adverse event rates between the Treatment and Control groups.

Official Title

Randomized Study of the pdSTIM™ System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically Ventilated Patients

Quick Facts

Study Start:2023-09-29
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05998018

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject is 18 years or older.
  2. 2. Subject, or subject's Legally Authorized Representative, understands study requirements, study visits, and is willing and able to provide written informed consent prior to study specific procedures or testing.
  3. 3. Subject has been on mechanical ventilation for ≥ 96 hours prior to randomization (intubation or tracheostomy).
  4. 4. Subject has failed at least 1 weaning attempt (e.g., site directed spontaneous breathing trial(s) did not result in liberation).
  5. 5. 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.
  1. 1. Subject has been on invasive mechanical ventilation for \> 45 days.
  2. 2. Subject failed to wean due to pre-existing neurological or neuromuscular issues affecting the respiratory muscles (e.g., ALS, phrenic nerve paralysis, inflammatory muscle disease, underlying myopathy, myasthenia gravis, cervical spinal injury).
  3. 3. Subject's medical history, known anatomy or investigator's inability to visualize necessary anatomical landmarks that could prevent the safe placement of the pdSTIM leads.
  4. 4. Subject is at risk of significant hemorrhage or is currently receiving a full dose of systemic anticoagulation (e.g., IV heparin, high dose of subcutaneous heparin. Subjects on prophylactic anticoagulation or daily aspirin regimen on their own are not excluded unless other exclusion criteria apply).
  5. 5. Subject has an implant or external electrical device that may interact or interfere with the pdSTIM System (examples may include cardiac pacemaker, implantable defibrillator, vagal nerve stimulator, spinal cord stimulator, gastric stimulator, diaphragmatic stimulator).
  6. 6. Subject has been diagnosed and has been treated for neck cancer within the past 5 years or subject had any prior radiation treatment to the neck.
  7. 7. 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 of norepinephrine or epinephrine, or equivalent, or is actively being titrated.
  8. 8. Subject has a local infection at or around the proposed pdSTIM Lead insertion site.
  9. 9. Subject is neutropenic or has signs of significant immunocompromise. (Subjects intubated for respiratory failure due to COVID-19 are not excluded unless other exclusion criteria apply).
  10. 10. Subject has severe COPD as indicated by evidence of significant expiratory obstruction on the ventilator flow waveform or, where ventilator flow waveforms are not utilized, has a FEV1 ≤ 30%.
  11. 11. Subject has pre-existing severe chronic pulmonary fibrosis.
  12. 12. Subject has pleural effusion occupying greater than 1/3 of the pleural space on either side.
  13. 13. Subject is currently on or expected to begin neuromuscular blockades.
  14. 14. Subject is anticipating withdrawal of life support and/or shift to palliation as the goal of care with less than 6-months life expectancy.
  15. 15. Subject is known or suspected to be pregnant or lactating.
  16. 16. Subject is currently enrolled in or exited early from a) any investigational drug study or b) an investigational device study that may impact the ability to wean or is directly related to the lungs or diaphragm.

Contacts and Locations

Study Contact

Head of Clinical
CONTACT
612-445-8252
clinical@stimdia.com

Principal Investigator

Steven Conrad, MD,PhD
PRINCIPAL_INVESTIGATOR
LSU Health Sciences Shreveport

Study Locations (Sites)

University of South Alabama
Mobile, Alabama, 36617
United States
Chandler Regional Medical Center
Chandler, Arizona, 85224
United States
Abrazo West Health
Goodyear, Arizona, 85395
United States
HonorHealth Research Institute
Scottsdale, Arizona, 85260
United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
United States
University of Illinois Chicago
Chicago, Illinois, 60612
United States
RML Specialty Hospital
Hinsdale, Illinois, 60521
United States
University of Louisville
Louisville, Kentucky, 40202
United States
Tulane University Medical Center
New Orleans, Louisiana, 70112
United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103
United States
University of Michigan Health - West
Wyoming, Michigan, 49519
United States
Bryan Medical Center
Lincoln, Nebraska, 68506
United States
Northwell South Shore University Hospital
Bay Shore, New York, 11706
United States
University at Buffalo
Buffalo, New York, 14203
United States
Atrium Health
Charlotte, North Carolina, 28203
United States
WakeMed Health
Raleigh, North Carolina, 27610
United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Baptist Clinical Research Institute, Inc.
Memphis, Tennessee, 38120
United States
St. David's Healthcare
Georgetown, Texas, 78626
United States
Houston Methodist
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Stimdia Medical Inc.

  • Steven Conrad, MD,PhD, PRINCIPAL_INVESTIGATOR, LSU Health Sciences Shreveport

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-29
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2023-09-29
Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

  • Mechanical Ventilation
  • Phrenic Nerve Stimulation

Additional Relevant MeSH Terms

  • Ventilator Induced Diaphragm Dysfunction