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Device

Treatment for Ventilator Induced Diaphragm Dysfunction (RESCUE3 Trial)

N/A

Waitlist Available

Research Sponsored by Lungpacer Medical Inc.

Eligibility Criteria Checklist

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

Must have

Are 18 years or older, and

Have been mechanically ventilated for ≥96 hours (4 days), and

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

RESCUE3 Trial Summary

This trial is testing a new device to help people with breathing issues who are on mechanical ventilation. The goal is to show that the device helps more people than the current standard of care.

RESCUE3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

RESCUE3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximal Inspiratory Pressure mean change

Successful wean

Secondary outcome measures

Change in MIP

Change in Rapid Shallow Breathing Index (RSBI)

Days on MV

+3 more

Other outcome measures

Adverse Event Assessment

RESCUE3 Trial Design

2Treatment groups

Active Control

Group I: TreatmentActive Control1 Intervention

Subject receives Lungpacer Catheter for transvenous phrenic nerve stimulation to deliver Diaphragm Pacing Therapy Sessions. DPT sessions are 6 sets of 10, delivered twice daily, for a total of 120 stimulation reps per day, plus standard of care for weaning from mechanical ventilation.

Group II: ControlActive Control1 Intervention

Subject does not receive Lungpacer Catheter or DPT. Subject receives only Standard of care for weaning from mechanical ventilation.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lungpacer Medical Inc.Lead Sponsor

6 Previous Clinical Trials

189 Total Patients Enrolled

2 Trials studying Ventilator Induced Diaphragm Dysfunction

119 Patients Enrolled for Ventilator Induced Diaphragm Dysfunction

Frequently Asked Questions

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

Could you tell me how many research facilities are included in this project?

"Patients can be treated at Lahey Hospital and Medical Center in Burlington, Massachusetts, Englewood Hospital Medical Center in Englewood, New jersey, Rush University Medical Center in Chicago, Illinois, and 20 other locations."

Answered by AI

Can people still join this research project?

"Yes, this study is still recruiting patients, as detailed on clinicaltrials.gov. The posting went up on 6/14/2019 and the most recent update was on 12/2/2021."

Answered by AI

What do researchers hope to accomplish with this clinical trial?

"The main aim of this study, as measured by Maximal Inspiratory Pressure mean change over 30 days, is to...? Additionally, this trial will also track objectives including change in MIP, days on mechanical ventilation, and change in Rapid Shallow Breathing Index."

Answered by AI

How many people are included as part of this test group?

"400 patients that meet the necessary inclusion criteria are required for the study to commence. The sponsor, Lungpacer Medical Inc., will be conducting the trial from multiple locations, such as Lahey Hospital and Medical Center in Burlington, Massachusetts, and Englewood Hospital Medical Center in Englewood, New jersey."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation

2019. "A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03783884.