Randomized Study of the pdSTIM™ System in Failure to Wean Mechanically Ventilated Patients

NCT05998018 | Terminated DMC FDA Device

• 1 other identifier: CIP0002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Phrenic Nerve Stimulation; Ventilator Induced Diaphragm Dysfunction; Mechanical Ventilation Weaning; Neuromodulation

Keywords

Mechanical Ventilation; Phrenic Nerve Stimulation; Neuromodulation

Outcome Measures

Primary Outcomes (2)

• Time to Wean

  Assess time to successful weaning from mechanical ventilation for the subjects randomized to Treatment as compared to subjects randomized to Control

  Following completion of the 30-day follow-up by all available randomized subjects

• Assessment of Serious Adverse Events (SAEs)

  Assessment of Serious Adverse Events (SAEs) for the subjects randomized to Treatment as compared to subjects randomized to Control

  Following completion of the 30-day follow-up by all available randomized subjects

Secondary Outcomes (3)

• Mortality Rates

  Following completion of the 30-day follow-up by all available randomized subjects

• Adverse Event Rates

  Following completion of the 30-day follow-up by all available randomized subjects

• Days on Mechanical Ventilation

  Following completion of the 30-day follow-up by all available randomized subjects

Other Outcomes (4)

• pdSTIM System Summary

  Following completion of the 30-day follow-up by all available randomized subjects

• Mean Change in Rapid Shallow Breathing Index (RSBI)

  Following completion of the 30-day follow-up by all available randomized subjects

• Number of ICU Days

  Following completion of the 30-day follow-up by all available randomized subjects

Study Arms (2)

pdSTIM System Therapy

EXPERIMENTAL

Device: pdSTIM System Therapy; Other: Conventional Medical Management

Standard of Care

ACTIVE COMPARATOR

Other: Conventional Medical Management

Interventions

pdSTIM System Therapy DEVICE

Stimulate the phrenic nerves in synchrony with inspiratory cycles of the ventilator which exercises the diaphragm

pdSTIM System Therapy

Conventional Medical Management OTHER

Conventional medical management

Standard of Care; pdSTIM System Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18 years or older.
• 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.
• 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 spontaneous breathing 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.

You may not qualify if:

• Subject has been on invasive mechanical ventilation for \> 45 days.
• 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).
• 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.
• 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).
• 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.
• 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.
• Subject has a local infection at or around the proposed pdSTIM Lead insertion site.
• 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%.
• Subject has pre-existing severe chronic pulmonary fibrosis.
• Subject has pleural effusion occupying greater than 1/3 of the pleural space on either side.
• Subject is currently on or expected to begin neuromuscular blockades.
• Subject is anticipating withdrawal of life support and/or shift to palliation as the goal 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 drug study or b) an investigational device study that may impact the ability to wean or is directly related to the lungs or diaphragm.

Sponsors & Collaborators

• Stimdia Medical Inc.: lead

Study Sites (21)

University of South Alabama

Mobile, Alabama, 36617, United States

Location

Chandler Regional Medical Center

Chandler, Arizona, 85224, United States

Location

Abrazo West Campus

Goodyear, Arizona, 85395, United States

Location

HonorHealth Research Institute

Scottsdale, Arizona, 85260, United States

Location

Denver Health

Denver, Colorado, 80204, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

RML Specialty Hospital

Hinsdale, Illinois, 60521, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, 71103, United States

Location

University of Michigan Health - West

Wyoming, Michigan, 49519, United States

Location

Northwell South Shore University Hospital

Bay Shore, New York, 11706, United States

Location

University at Buffalo

Buffalo, New York, 14203, United States

Location

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

WakeMed Health

Raleigh, North Carolina, 27610, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

St. David's Healthcare

Georgetown, Texas, 78626, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Schaaf K, Mullin CM, Cunningham KW, Eaton J, Conrad SA. The ReInvigorate Study-phrenic nerve-to-diaphragm stimulation for weaning from mechanical ventilation: a protocol for a randomized pivotal clinical trial. Trials. 2024 Aug 2;25(1):519. doi: 10.1186/s13063-024-08355-8.

  PMID: 39095923 DERIVED

Related Links

• Company Website

Study Officials

• Steven Conrad, MD,PhD

  LSU Health Sciences Shreveport

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 18, 2023
• Study Start: September 29, 2023
• Primary Completion: April 14, 2025
• Study Completion: September 4, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)