Ventilator Induced Lung InjuryNCT02670460
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing, a First in Human Trial
A study testing LIVE Catheter in people with Ventilator Induced Lung Injury, run by Lungpacer Medical Inc. at 1 site in Paraguay.
Trial summary
Study conducted to confirm phrenic nerve stimulation using the Lungpacer LIVE Catheter, confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony with mechanical ventilator breaths. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Induced Lung Injury
- What is being tested?
- LIVE Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteParaguay
- Study dates
- Oct 2015to Apr 2016
- 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
- Able and willing to give informed consent or whose legally authorized representative is able and willing to give informed consent.
- Able to undergo general anaesthesia (sedation, intubation and mechanical ventilation)
- Susceptible indication for atrial septal defect closure
Who cannot join
- Subject has an EF of < 30%
- Subject has a co-morbid illness or life expectancy < 2 years
- Subject has experienced an AMI within 72 hours prior to this procedure
- Subject is contraindicated for or unwilling to take aspirin or anticoagulants
- Subject is in cardiogenic shock
- Subject has other cardiovascular disease requiring open heart surgery
Show all 16Show fewer
- Subject is known to have a demonstrated intra cardiac thrombus on echocardiography
- Subject has been treated with paralytic medications within 72 hours prior to procedure
- Subject has significant thoracic abnormalities such that placement of a left subclavian line would be difficult
- Inability to cannulate the left subclavian vein (post-consent exclusion)
- Subject has a known or suspected phrenic nerve paralysis
- Subject has co-existing temporary or implanted cardiac electrical devices such as a pacemaker or defibrillator
- Subject has an active systemic infection or local infection at or around the insertion site
- Subject is known or suspected to be pregnant or is lactating
- Subject will be unavailable for, or is unwilling to comply with, follow up requirements of the protocol
- Subject is currently enrolled in any other study of an investigational drug or device who has received treatment under that protocol with the investigational product during the 30 days prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Study conducted to confirm phrenic nerve stimulation using the Lungpacer LIVE Catheter, confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony with mechanical ventilator breaths.
Read the detailed description
This study is being conducted to determine if in an anaesthetized (sedated, intubated and mechanically ventilated) subject the LIVE Catheter can be inserted percutaneously and activated via the electrical stimulator to stimulate the left and right phrenic nerves causing the diaphragm to contract in synchrony with mechanical ventilator breaths via phrenic nerve stimulation from a transvenously delivered electrical current.
- Conditions
- Ventilator Induced Lung Injury
- Being tested
- LIVE Catheter
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIVE CatheterDevice
Placement of a temporary LIVE Catheter central venous pacing device in the left subclavian vein to pace the phrenic nerves and allow recruitment of the diaphragm muscle.
| Study group | Role | What they receive |
|---|---|---|
| Temporary diaphragmatic pacing | Experimental | There is no comparator for this study. Single site and all patients are in the treatment allocated group of temporary diaphragmatic pacing with the LIVE Catheter which is inserted via the left subclavian vein. Receives: Device: LIVE Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful insertion of the LIVE Catheter into the left subclavian vien
Confirmation by cinefluoroscopy of the insertion of the LIVE Catheter into the Left subclavian vein with the tip located in the superior vena cava
Measured: at time of procedure
Absence of device related or procedure related adverse events
Assess subject AE status out to 48 hours post procedure
Measured: up to 48 hours or at time of discharge whichever comes first
Secondary outcomes (1)
Phrenic nerve stimulation in synchrony with MV breaths
Phrenic nerve stimulation in synchrony with MV breaths as defined by contraction of the diaphragm upon energy delivery.
Measured: No more than 90 minutes procedure duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ventilator Induced Lung InjuryStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lungpacer Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Reynolds, MD, Study director, Lungpacer Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670460
- Sponsor's protocol ID
- TPR-0046 and CLN-0005
- Status last verified
- Apr 2016
- First submitted
- 27 Jan 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Discussing a publication for FIH
Publications
Penuelas O, Frutos-Vivar F, Fernandez C, Anzueto A, Epstein SK, Apezteguia C, Gonzalez M, Nin N, Raymondos K, Tomicic V, Desmery P, Arabi Y, Pelosi P, Kuiper M, Jibaja M, Matamis D, Ferguson ND, Esteban A; Ventila Group. Characteristics and outcomes of ventilated patients according to time to liberation from mechanical ventilation. Am J Respir Crit Care Med. 2011 Aug 15;184(4):430-7. doi: 10.1164/rccm.201011-1887OC.
PubMed 21616997Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.
PubMed 24283226Supinski GS, Callahan LA. Diaphragm weakness in mechanically ventilated critically ill patients. Crit Care. 2013 Jun 20;17(3):R120. doi: 10.1186/cc12792.
PubMed 23786764Gayan-Ramirez G. Ventilator-induced diaphragm dysfunction: time for (contr)action! Eur Respir J. 2013 Jul;42(1):12-5. doi: 10.1183/09031936.00076513. No abstract available.
PubMed 23813310
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. 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, a First in Human Trial
- ClinicalTrials.gov ID
- NCT02670460
- Acronym / sponsor ID
- TPR-0046 and CLN-0005
- Conditions
- Ventilator Induced Lung Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lungpacer Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 1 Feb 2016 (estimated)
- 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.
Study conducted to confirm phrenic nerve stimulation using the Lungpacer LIVE Catheter, confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony with mechanical ventilator breaths.
Detailed description
This study is being conducted to determine if in an anaesthetized (sedated, intubated and mechanically ventilated) subject the LIVE Catheter can be inserted percutaneously and activated via the electrical stimulator to stimulate the left and right phrenic nerves causing the diaphragm to contract in synchrony with mechanical ventilator breaths via phrenic nerve stimulation from a transvenously delivered electrical current.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temporary diaphragmatic pacing | Experimental | Device: LIVE CatheterThere is no comparator for this study. Single site and all patients are in the treatment allocated group of temporary diaphragmatic pacing with the LIVE Catheter which is inserted via the left subclavian vein. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able and willing to give informed consent or whose legally authorized representative is able and willing to give informed consent.
- Able to undergo general anaesthesia (sedation, intubation and mechanical ventilation)
- Susceptible indication for atrial septal defect closure
Key exclusion criteria (16 listed)
- Subject has an EF of < 30%
- Subject has a co-morbid illness or life expectancy < 2 years
- Subject has experienced an AMI within 72 hours prior to this procedure
- Subject is contraindicated for or unwilling to take aspirin or anticoagulants
- Subject is in cardiogenic shock
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 |
|---|---|---|
| LIVE CatheterPlacement of a temporary LIVE Catheter central venous pacing device in the left subclavian vein to pace the phrenic nerves and allow recruitment of the diaphragm muscle. | Device | Temporary diaphragmatic pacing |
Primary outcome
Successful insertion of the LIVE Catheter into the left subclavian vien
Time frame: at time of procedure
Confirmation by cinefluoroscopy of the insertion of the LIVE Catheter into the Left subclavian vein with the tip located in the superior vena cava
Absence of device related or procedure related adverse events
Time frame: up to 48 hours or at time of discharge whichever comes first
Assess subject AE status out to 48 hours post procedure
1 secondary outcome
Phrenic nerve stimulation in synchrony with MV breaths
Time frame: No more than 90 minutes procedure duration
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 15 Apr 2016.
- Background: PubMed 21616997Penuelas O, Frutos-Vivar F, Fernandez C, Anzueto A, Epstein SK, Apezteguia C, Gonzalez M, Nin N, Raymondos K, Tomicic V, Desmery P, Arabi Y, Pelosi P, Kuiper M, Jibaja M, Matamis D, Ferguson ND, Esteban A; Ventila Group. Characteristics and outcomes of ventilated patients according to time to liberation from mechanical ventilation. Am J Respir Crit Care Med. 2011 Aug 15;184(4):430-7. doi: 10.1164/rccm.201011-1887OC.
- Background: PubMed 24283226Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.
- Background: PubMed 23786764Supinski GS, Callahan LA. Diaphragm weakness in mechanically ventilated critically ill patients. Crit Care. 2013 Jun 20;17(3):R120. doi: 10.1186/cc12792.
- Background: PubMed 23813310Gayan-Ramirez G. Ventilator-induced diaphragm dysfunction: time for (contr)action! Eur Respir J. 2013 Jul;42(1):12-5. doi: 10.1183/09031936.00076513. No abstract available.
- Individual participant dataSharing planned: Undecided. Discussing a publication for FIH
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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.
Steve Reynolds, MD study director
Lungpacer Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIVE Catheter in people with Ventilator Induced Lung Injury, run by Lungpacer Medical Inc. at 1 site in Paraguay.
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 16 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 15 Apr 2016. 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 Paraguay. 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 insertion of the LIVE Catheter into the left subclavian vien (time frame: at time of procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02670460, which also lists 4 linked publications.
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 15 Apr 2016.