Ventilator Induced Diaphragm DysfunctionRESCUE1NCT03107949
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing (RESCUE1)
A study testing Lungpacer DPTS (Diaphragm Pacing Therapy System) in people with Ventilator Induced Diaphragm Dysfunction, run by Lungpacer Medical Inc. at 4 sites in United States.
Trial summary
An early feasibility study to investigate the safety and feasibility of the Lungpacer Diaphragm Pacing Therapy System (DPTS) as a therapy to recondition and strengthen the diaphragm of patients who have been intubated and invasively mechanically ventilated for > or = 7 days, have failed two or more spontaneous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Induced Diaphragm Dysfunction
- What is being tested?
- Lungpacer DPTS (Diaphragm Pacing Therapy System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Jun 2017to 18 Feb 2018
- 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
- 18 years of age or older
- have been mechanically ventilated for > or = 7 days and have not met criteria for successful weaning during this period; and
- have failed at least two SBTs, one of which is the study specific SBT. (Self-extubation with subsequent reintubation within 48 hours is considered a failed SBT).
Who cannot join
- currently on extracorporeal membrane oxygenation (ECMO);
- weaning failure due to hypervolemia;
- known anatomy that prevents insertion of the LIVE Catheter into the left subclavian vein;
- history of congenital heart disease;
- clinically overt congestive heart failure;
- pre-existing neuromuscular diseases that could affect the respiratory muscles;
Show all 15Show fewer
- pleural effusions occupying greater than one third of the pleural space on either side;
- BMI > or = 40;
- known or suspected phrenic nerve paralysis;
- any electrical device (implanted or external) that may be prone to interaction with or interference from the Lungpacer DPTS including neurological pacing/stimulator devices, cardiac pacemakers and defibrillators;
- bacteremia (blood cultures must be negative for 48 hours);
- current haemodynamic instability, shock or severe sepsis;
- terminally ill with 6 months or less life expectancy or not committed to full care;
- known or suspected to be pregnant or lactating; and
- actively participating in another clinical study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Florida Health Science Center - Shands
Gainesville, Florida, 32610
New York University Medical Center
New York, New York, 10016
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Official title: Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing
An early feasibility study to investigate the safety and feasibility of the Lungpacer Diaphragm Pacing Therapy System (DPTS) as a therapy to recondition and strengthen the diaphragm of patients who have been intubated and invasively mechanically ventilated for > or = 7 days, have failed two or more spontaneous breathing trials (SBT), and were not hypervolemic during the latest SBT.
Read the detailed description
Mechanical ventilation (MV) is a life saving technology but can also cause damage to the lungs and diaphragm such as ventilator induced diaphragmatic dysfunction (VIDD). Research has shown that after being on mandatory MV and sedated the diaphragm begins to atrophy within as little as 18 hours. The DPTS is a temporary therapy that consists of the Lungpacer IntraVenous Electrode Catheter (LIVE Catheter) and the lungpacer Control Unit (LCU) system. The LIVE Catheter is a proprietary central venous catheter that incorporates pacing electrodes in strategic areas that align with the left and right phrenic nerves in order to stimulate the nerves to recruit the diaphragm. The LIVE Catheter can also be used for fluid delivery like any other central venous catheter. This early feasibility trial will investigate the safety and feasibility of the DPTS as a therapy to recondition and strengthen the diaphragm by stimulating the diaphragm through daily sessions so the patient may be more quickly liberated from MV. The patient population includes those who have been mechanically ventilated for > or = to 7 days, have failed two or more SBTs, and were not hypervolemic during the latest SBT. Patients must have resolution of the initial indication for placement on MV before entering the trial.
- Conditions
- Ventilator Induced Diaphragm Dysfunction
- Being tested
- Lungpacer DPTS (Diaphragm Pacing Therapy System)
- Keywords
- Diaphragm atrophy, VIDD, weaning failure, SBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lungpacer DPTS (Diaphragm Pacing Therapy System)Device
Also called LIVE Catheter; RESCUE 1
Lungpacer Diaphragm Pacing therapy (DPTS) will be conducted in daily sessions until the patient has been extubated or day 30 if not extubated.
| Study group | Role | What they receive |
|---|---|---|
| Lungpacer Diaphragm Pacing Therapy (DPTS) | Experimental | The LIVE Catheter will be temporarily inserted (LIVE Catheter will be inserted into every patient enrolled and can stay in place for up to 30 days) into the left subclavian vein and connected to the Lungpacer Control Unit in order to perform diaphragm pacing to stimulate the phrenic nerves and activate the diaphragm 3 x a day on all patients until extubated/removed from mechanical ventilation or until day 30 whichever comes first. Receives: Device: Lungpacer DPTS (Diaphragm Pacing Therapy System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Placement of the LIVE Catheter
Successful placement of the LIVE Catheter via the Left Subclavian vein at the initiation of study will be assessed by placement confirmation via Chest Xray
Measured: You will undergo an evaluation immediately following the LIVE Catheter insertion procedure to confirm that the LIVE Catheter has been successfully placed in the correct position in your vein.
Capture of phrenic nerve
Successful capture and stimulation of at least one phrenic nerve as assessed by the change in the ventilator waveform and or diaphragm contraction.
Measured: Measured during daily Diaphragm Pacing Therapy sessions from time of LIVE Catheter insertion to time of extubation or day 30 whichever comes first
Diaphragm contraction noted upon stimulation of the phrenic nerve
Demonstration of the ability to contract the diaphragm via phrenic nerve stimulation will be evaluated by palpation of the diaphragm or visualization of the ventilator waveform change.
Measured: Measured during daily Diaphragm Pacing Therapy sessions from time of LIVE Catheter insertion to time of extubation or day 30 whichever comes first.
Removal of LIVE Catheter
Successful removal of the LIVE Catheter two days after date of extubation but before the end of the study on day 32
Measured: Removal of LIVE Catheter will occur 2 days after extubation or on day 30 if subject has not been extubated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start20 Jun 2017
- Primary completion30 Jan 2018
- Study completion18 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Induced Diaphragm DysfunctionStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- LIVE Catheter is temporarily insertied into the left subclavian vein and connected to the LCU for DPTS to be delivered daily. The DPTS includes the LIVE Catheter, LCU and intermediate cable.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lungpacer Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Responsible party
- Sponsor
- Investigators
- Linda Clark, RN, BSN, Study director, Vice Presdient of Clinical Affairs, Lungpacer Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107949
- Sponsor's protocol ID
- P-100
- Other IDs
- G170057
- Acronym
- RESCUE1
- Status last verified
- May 2021
- First submitted
- 21 Mar 2017
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Only investigators participating in this clinical trial will be able to see final de-identified participant data at the completion of the study and it will be available through Syntactx.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing
- ClinicalTrials.gov ID
- NCT03107949
- Acronym / sponsor ID
- RESCUE1 / P-100
- Conditions
- Ventilator Induced Diaphragm Dysfunction
- Keywords
- Diaphragm atrophy, VIDD, weaning failure, SBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Lungpacer Medical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 18 Feb 2018 (actual)
- First posted
- 11 Apr 2017 (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.
An early feasibility study to investigate the safety and feasibility of the Lungpacer Diaphragm Pacing Therapy System (DPTS) as a therapy to recondition and strengthen the diaphragm of patients who have been intubated and invasively mechanically ventilated for > or = 7 days, have failed two or more spontaneous breathing trials (SBT), and were not hypervolemic during the latest SBT.
Detailed description
Mechanical ventilation (MV) is a life saving technology but can also cause damage to the lungs and diaphragm such as ventilator induced diaphragmatic dysfunction (VIDD). Research has shown that after being on mandatory MV and sedated the diaphragm begins to atrophy within as little as 18 hours. The DPTS is a temporary therapy that consists of the Lungpacer IntraVenous Electrode Catheter (LIVE Catheter) and the lungpacer Control Unit (LCU) system. The LIVE Catheter is a proprietary central venous catheter that incorporates pacing electrodes in strategic areas that align with the left and right phrenic nerves in order to stimulate the nerves to recruit the diaphragm. The LIVE Catheter can also be used for fluid delivery like any other central venous catheter. This early feasibility trial will investigate the safety and feasibility of the DPTS as a therapy to recondition and strengthen the diaphragm by stimulating the diaphragm through daily sessions so the patient may be more quickly liberated from MV. The patient population includes those who have been mechanically ventilated for > or = to 7 days, have failed two or more SBTs, and were not hypervolemic during the latest SBT. Patients must have resolution of the initial indication for placement on MV before entering the trial.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- LIVE Catheter is temporarily insertied into the left subclavian vein and connected to the LCU for DPTS to be delivered daily. The DPTS includes the LIVE Catheter, LCU and intermediate cable.
| Arm | Type | Receives |
|---|---|---|
| Lungpacer Diaphragm Pacing Therapy (DPTS) | Experimental | Device: Lungpacer DPTS (Diaphragm Pacing Therapy System)The LIVE Catheter will be temporarily inserted (LIVE Catheter will be inserted into every patient enrolled and can stay in place for up to 30 days) into the left subclavian vein and connected to the Lungpacer Control Unit in order to perform diaphragm pacing to stimulate the phrenic nerves and activate the diaphragm 3 x a day on all patients until extubated/removed from mechanical ventilation or until day 30 whichever comes first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- have been mechanically ventilated for > or = 7 days and have not met criteria for successful weaning during this period; and
- have failed at least two SBTs, one of which is the study specific SBT. (Self-extubation with subsequent reintubation within 48 hours is considered a failed SBT).
Key exclusion criteria (15 listed)
- currently on extracorporeal membrane oxygenation (ECMO);
- weaning failure due to hypervolemia;
- known anatomy that prevents insertion of the LIVE Catheter into the left subclavian vein;
- history of congenital heart disease;
- clinically overt congestive heart failure;
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 DPTS (Diaphragm Pacing Therapy System)Also: LIVE Catheter; RESCUE 1Lungpacer Diaphragm Pacing therapy (DPTS) will be conducted in daily sessions until the patient has been extubated or day 30 if not extubated. | Device | Lungpacer Diaphragm Pacing Therapy (DPTS) |
Primary outcome
Successful Placement of the LIVE Catheter
Time frame: You will undergo an evaluation immediately following the LIVE Catheter insertion procedure to confirm that the LIVE Catheter has been successfully placed in the correct position in your vein.
Successful placement of the LIVE Catheter via the Left Subclavian vein at the initiation of study will be assessed by placement confirmation via Chest Xray
Capture of phrenic nerve
Time frame: Measured during daily Diaphragm Pacing Therapy sessions from time of LIVE Catheter insertion to time of extubation or day 30 whichever comes first
Successful capture and stimulation of at least one phrenic nerve as assessed by the change in the ventilator waveform and or diaphragm contraction.
Diaphragm contraction noted upon stimulation of the phrenic nerve
Time frame: Measured during daily Diaphragm Pacing Therapy sessions from time of LIVE Catheter insertion to time of extubation or day 30 whichever comes first.
Demonstration of the ability to contract the diaphragm via phrenic nerve stimulation will be evaluated by palpation of the diaphragm or visualization of the ventilator waveform change.
Removal of LIVE Catheter
Time frame: Removal of LIVE Catheter will occur 2 days after extubation or on day 30 if subject has not been extubated.
Successful removal of the LIVE Catheter two days after date of extubation but before the end of the study on day 32
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 10 May 2021.
- Individual participant dataSharing planned: Undecided. Only investigators participating in this clinical trial will be able to see final de-identified participant data at the completion of the study and it will be available through Syntactx.
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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.
Linda Clark, RN, BSN study director
Vice Presdient of Clinical Affairs, Lungpacer Medical, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lungpacer DPTS (Diaphragm Pacing Therapy System) in people with Ventilator Induced Diaphragm Dysfunction, run by Lungpacer Medical Inc. at 4 sites in United States.
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 3 inclusion and 15 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 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Successful Placement of the LIVE Catheter (time frame: You will undergo an evaluation immediately following the LIVE Catheter insertion procedure to confirm that the LIVE Catheter has been successfully placed in the correct position in your vein.). The study lists 4 primary outcomes in all. 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 10 May 2021.