Acute Respiratory Distress SyndromePIRATNCT04844892
Phrenic Nerve Stimulation-Induced Lung ReAeration Trial
A study testing Lungpacer PROTECT Diaphragm Pacing Therapy in people with Acute Respiratory Distress Syndrome and Ventilation Therapy; Complications, run by Lungpacer Medical Inc. at 1 site in France.
Trial summary
The Lungpacer PROTECT Diaphragm Pacing Therapy System (DPTS) is a temporary, percutaneously-placed, transvenous, phrenic nerve-stimulating device intended to stimulate the diaphragm to preserve and improve inspiratory muscle strength in mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Ventilation Therapy; Complications
- What is being tested?
- Lungpacer PROTECT Diaphragm Pacing Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 25 Aug 2021to 13 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are 18 years or older
- Have been mechanically ventilated due to moderate ARDS for 48-120h
- Have a PaO2/FiO2 ratio < 200 and > 100 at the time of screening with PEEP ≥ 5 cmH2O
- Are expected to remain on mechanical ventilation ≥ 48 hours
- Are under continuous sedation with Richmond Agitation Sedation Scale (RASS) ≤ -3
Who cannot join
- Septic shock with hemodynamic instability (norepinephrine or epinephrine < 0.5 gamma/kg/min)
- Catheter access to left subclavian vein deemed impossible
- Use of neuromuscular blocking agents within last 12 hours
- Bacteremia within the last 48 hours or uncontrolled source of infection
- Currently on ECMO
- Enrolled in any other study of an investigational drug or device, which may affect the outcomes of the current study
Show all 14Show fewer
- Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles
- BMI >45 kg/m2
- Known or suspected phrenic nerve paralysis
- Any electrical device (implanted or external) that may be prone to interaction with or interference from the Lungpacer PROTECT DPTS, including neurological pacing/stimulator devices and cardiac pacemakers and defibrillators
- No affiliation to the French health insurance system
- Under curatorship
- Imprisoned
- Known or suspected to be pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Protocol Investigating the Impact of Lungpacer PROTECT Diaphragm Pacing Therapy on Gas Exchange, Hemodynamics, Regional Lung Ventilation and Atelectasis in Patients Presenting With Moderate ARDS
The Lungpacer PROTECT Diaphragm Pacing Therapy System (DPTS) is a temporary, percutaneously-placed, transvenous, phrenic nerve-stimulating device intended to stimulate the diaphragm to preserve and improve inspiratory muscle strength in mechanically ventilated patients. The purpose of the PROTECT DPTS is to improve gas exchange, regional lung ventilation, and hemodynamics, and decrease atelectasis in patients presenting with acute respiratory distress syndrome (ARDS).
Read the detailed description
The PIRAT clinical study is intended to assess the feasibility, safety and effectiveness of transvenous phrenic-nerve-stimulating diaphragm pacing on clinical outcomes in mechanically ventilated patients. By delivering electrical stimulation to the phrenic nerves, which in turn causes the diaphragm muscle to contract, the PROTECT DPTS is intended to protect the diaphragm from atrophy and preserve lung mechanics to reduce lung inflammation and injury associated with short-term mechanical ventilation. Sustained lung and diaphragm health during early mechanical ventilation is expected to reduce the risk of comorbidities, improve clinical outcomes such as weaning success, and thereby reduce the number of patients who require prolonged mechanical ventilation.
- Being tested
- Lungpacer PROTECT Diaphragm Pacing Therapy
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lungpacer PROTECT Diaphragm Pacing TherapyDevice
Also called Lungpacer PROTECT DPTS
PROTECT diaphragm pacing therapy is intended to stimulate the diaphragm to preserve and improve inspiratory muscle strength in mechanically ventilated patients.
| Study group | Role | What they receive |
|---|---|---|
| PROTECT Diaphragm Pacing Therapy | Experimental | Not described Receives: Device: Lungpacer PROTECT Diaphragm Pacing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in PaO2/FiO2 ratio
The changes in PaO2/FiO2 ratio during each acute standard of care ventilation and acute PROTECT pacing therapy session.
Measured: Day 1
Secondary outcomes (6)
Successful LIVE catheter placement
LIVE Catheter was successfully inserted into the left subclavian vein, positioned in accordance with the LIVE Catheter IFU, and the diaphragm was stimulated.
Measured: Day 1
Alveolar-arterial (A-a) gradient
Alveolar-arterial (A-a) gradient documenting gas exchange during each acute standard of care ventilation and acute PROTECT pacing therapy session.
Measured: Day 1
Cardiac output index
Pulse contour cardiac output index assessed by transpulmonary thermodilution during each acute standard of care ventilation and acute PROTECT pacing therapy session.
Measured: Day 1
Regional lung ventilation
Regional lung ventilation assessed using electrical impedance tomography during each acute standard of care ventilation and acute PROTECT pacing therapy session.
Measured: Day 1
Regional lung atelectasis
Regional lung atelectasis assessed using electrical impedance tomography during each acute standard of care ventilation and acute PROTECT pacing therapy session.
Measured: Day 1
Serious adverse events
Occurrence of pneumothorax, significant bleeding and desaturation serious adverse events.
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start25 Aug 2021
- Primary completion1 Feb 2023
- Study completion13 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lungpacer Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Dres, MD, Principal investigator, AP-HP Hôpital La Pitié-Salpêtrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844892
- Sponsor's protocol ID
- P-400
- Acronym
- PIRAT
- Status last verified
- Oct 2023
- First submitted
- 8 Apr 2021
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Protocol Investigating the Impact of Lungpacer PROTECT Diaphragm Pacing Therapy on Gas Exchange, Hemodynamics, Regional Lung Ventilation and Atelectasis in Patients Presenting With Moderate ARDS
- ClinicalTrials.gov ID
- NCT04844892
- Acronym / sponsor ID
- PIRAT / P-400
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Lungpacer Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Lungpacer PROTECT Diaphragm Pacing Therapy System (DPTS) is a temporary, percutaneously-placed, transvenous, phrenic nerve-stimulating device intended to stimulate the diaphragm to preserve and improve inspiratory muscle strength in mechanically ventilated patients. The purpose of the PROTECT DPTS is to improve gas exchange, regional lung ventilation, and hemodynamics, and decrease atelectasis in patients presenting with acute respiratory distress syndrome (ARDS).
Detailed description
The PIRAT clinical study is intended to assess the feasibility, safety and effectiveness of transvenous phrenic-nerve-stimulating diaphragm pacing on clinical outcomes in mechanically ventilated patients. By delivering electrical stimulation to the phrenic nerves, which in turn causes the diaphragm muscle to contract, the PROTECT DPTS is intended to protect the diaphragm from atrophy and preserve lung mechanics to reduce lung inflammation and injury associated with short-term mechanical ventilation. Sustained lung and diaphragm health during early mechanical ventilation is expected to reduce the risk of comorbidities, improve clinical outcomes such as weaning success, and thereby reduce the number of patients who require prolonged mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROTECT Diaphragm Pacing Therapy | Experimental | Device: Lungpacer PROTECT Diaphragm Pacing Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are 18 years or older
- Have been mechanically ventilated due to moderate ARDS for 48-120h
- Have a PaO2/FiO2 ratio < 200 and > 100 at the time of screening with PEEP ≥ 5 cmH2O
- Are expected to remain on mechanical ventilation ≥ 48 hours
- Are under continuous sedation with Richmond Agitation Sedation Scale (RASS) ≤ -3
Key exclusion criteria (14 listed)
- Septic shock with hemodynamic instability (norepinephrine or epinephrine < 0.5 gamma/kg/min)
- Catheter access to left subclavian vein deemed impossible
- Use of neuromuscular blocking agents within last 12 hours
- Bacteremia within the last 48 hours or uncontrolled source of infection
- Currently on ECMO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lungpacer PROTECT Diaphragm Pacing TherapyAlso: Lungpacer PROTECT DPTSPROTECT diaphragm pacing therapy is intended to stimulate the diaphragm to preserve and improve inspiratory muscle strength in mechanically ventilated patients. | Device | PROTECT Diaphragm Pacing Therapy |
Primary outcome
Changes in PaO2/FiO2 ratio
Time frame: Day 1
The changes in PaO2/FiO2 ratio during each acute standard of care ventilation and acute PROTECT pacing therapy session.
6 secondary outcomes
Successful LIVE catheter placement
Time frame: Day 1
Alveolar-arterial (A-a) gradient
Time frame: Day 1
Cardiac output index
Time frame: Day 1
Regional lung ventilation
Time frame: Day 1
Regional lung atelectasis
Time frame: Day 1
Serious adverse events
Time frame: Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Dres, MD principal investigator
AP-HP Hôpital La Pitié-Salpêtrière
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lungpacer PROTECT Diaphragm Pacing Therapy in people with Acute Respiratory Distress Syndrome and Ventilation Therapy; Complications, run by Lungpacer Medical Inc. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in PaO2/FiO2 ratio (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.