What side effects are associated with this type of intervention?

Phrenic nerve stimulation, a treatment for Ventilator Induced Diaphragm Dysfunction, can lead to side effects such as pain at the stimulation site, infection, and potential damage to the phrenic nerve. Mechanical ventilation itself can cause diaphragmatic atrophy and contractile dysfunction, which may worsen over time. Other general side effects of mechanical ventilation include ventilator-associated pneumonia, barotrauma, and hemodynamic instability.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Ventilator Induced Diaphragm Dysfunction (VIDD) in the provided context. The pdSTIM System, which uses phrenic nerve stimulation to facilitate weaning from mechanical ventilation, is currently being evaluated in a clinical trial. This suggests that similar treatments may still be under investigation and not yet widely approved.

What other types of research exist?

Promising alternatives to the pdSTIM System for treating Ventilator Induced Diaphragm Dysfunction include: 1) Diaphragmatic Pacing, which has been used successfully in patients with ventilatory failure due to diaphragmatic palsy, and 2) High-Frequency Chest Wall Oscillation (HFCWO), which has shown efficacy in airway clearance and improving respiratory function in patients with neuromuscular diseases. Both methods have demonstrated potential in clinical settings and could be considered as viable options for VIDD patients in 2024.

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Procedure

pdSTIM System Therapy for Difficulty Weaning from Mechanical Ventilation (ReInvigorate Trial)

N/A

Recruiting

Led By Steven Conrad, MD,PhD

Research Sponsored by Stimdia Medical Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up following completion of the 30-day follow-up by all available randomized subjects

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device called the pdSTIM System that helps patients who have been on a ventilator for several days and couldn't stop using it. The device stimulates a nerve to strengthen breathing muscles, making it easier for patients to breathe without the ventilator. Using electrical stimulation to help breathing muscles has been explored as an alternative method to mechanical ventilation for patients with breathing difficulties.

Who is the study for?

This trial is for adults aged 22 or older who have been on mechanical ventilation for at least four days and failed one weaning attempt. They should be expected to need ventilation for at least another two days. Pregnant women, those with certain medical devices, severe lung conditions, recent neck cancer treatments, or significant bleeding risks are excluded.

What is being tested?

The study tests the pdSTIM System's ability to help patients stop needing a ventilator by stimulating the phrenic nerve. Participants will either receive standard care alone (Control group) or standard care plus the pdSTIM System therapy (Treatment group), assigned randomly in equal numbers.

What are the potential side effects?

Potential side effects of the pdSTIM System may include discomfort at the stimulation site, possible interference with other medical devices if present, and potential risk of infection or bleeding where leads are placed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ following completion of the 30-day follow-up by all available randomized subjects

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~following completion of the 30-day follow-up by all available randomized subjects

This trial's timeline: 3 weeks for screening, Varies for treatment, and following completion of the 30-day follow-up by all available randomized subjects for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of Serious Adverse Events (SAEs)

Time to Wean

Secondary study objectives

Adverse Event Rates

Days on Mechanical Ventilation

Mortality Rates

Other study objectives

Mean Change in Rapid Shallow Breathing Index (RSBI)

Number of ICU Days

Rate of Re-intubation

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: pdSTIM System TherapyExperimental Treatment1 Intervention

Group II: Standard of CareActive Control1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Ventilator Induced Diaphragm Dysfunction (VIDD) include phrenic nerve stimulation and diaphragmatic pacing. Phrenic nerve stimulation works by electrically activating the phrenic nerve, which in turn stimulates the diaphragm to contract, thereby maintaining muscle tone and preventing atrophy. Diaphragmatic pacing involves the use of implanted electrodes to provide regular electrical impulses to the diaphragm, mimicking natural breathing patterns. These treatments are crucial for VIDD patients as they help preserve diaphragm function, improve respiratory outcomes, and facilitate weaning from mechanical ventilation, ultimately reducing the risk of long-term respiratory complications.

[Practical methods for controlled diaphragmatic breathing in 2009: proposals for a consensus].