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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

ReInvigorate Trial Summary

This trial evaluates a system to help people with breathing machines wean off them. Subjects are randomized between a treatment group with the system and a control group with standard care. Primary endpoints are time to weaning and serious adverse event rates.

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.Check my eligibility

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.See study design

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.

ReInvigorate Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment of Serious Adverse Events (SAEs)

Time to Wean

Secondary outcome measures

Adverse Event Rates

Days on Mechanical Ventilation

Mean Change in Maximal Inspiratory Pressure (MIP)

+1 more

Other outcome measures

Mean Change in Rapid Shallow Breathing Index (RSBI)

Number of ICU Days

Rate of Re-intubation

+1 more

ReInvigorate Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: pdSTIM System TherapyExperimental Treatment1 Intervention

Group II: Standard of CareActive Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Stimdia Medical Inc.Lead Sponsor

1 Previous Clinical Trials

12 Total Patients Enrolled

Steven Conrad, MD,PhDPrincipal InvestigatorLSU Health Sciences Shreveport

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation actively seeking participants?

"Affirmative. According to clinicaltrials.gov, this research project is still searching for subjects. The initial post was created on September 29th 2023 and the latest update occurred on October 3rd of the same year. 420 participants are anticipated across three sites."

Answered by AI

How many volunteers are currently participating in this research?

"Affirmative. Clinicaltrials.gov corroborates that this clinical trial, which was published on September 29th 2023, is open for enrollment. 420 participants need to be sourced from 3 separate sites."

Answered by AI

What are the desired results of this experiment?

"This trial aims to evaluate Serious Adverse Events (SAEs) following a 30-day follow-up of randomized subjects. Secondary objectives include assessment of mortality rates, adverse event rates, and days on mechanical ventilation between Treatment and Control groups."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Randomized Study of the pdSTIM™ System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically Ventilated Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05998018.

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