Ventilator-Induced Lung InjuryNCT03659552
Percutaneous Temporary Placement of a Transvenous Phrenic Nerve Stimulator for Diaphragm Pacing Using Jugular Access
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 a transvenous Phrenic Nerve Stimulator in the left jugular vein. 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
- 13 participants
- Where
- 1 siteParaguay
- Study dates
- 7 May 2018to 30 Aug 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;
- Able and willing to give informed consent or whose legally authorized representative is able and willing to give informed consent;
- Able to undergo general anesthesia (sedation, intubation, and mechanical ventilation);
- Acceptable indication for atrial septal defect closure.
Who cannot join
- Subject has an ejection fraction of < 30%
- Subject has a co-morbid illness or life expectancy < 2 years
- Subject has experienced an acute myocardial infarction 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
Official title: Feasibility of Using a Percutaneous Temporary Placement of a Transvenous Phrenic Nerve Stimulator for Diaphragm Pacing Using Jugular Access
Study conducted to confirm phrenic nerve stimulation using the a transvenous Phrenic Nerve Stimulator in the left jugular vein.
Read the detailed description
The Lungpacer Jugular Access Feasibility System is a prototype for the Lungpacer Diaphragm Pacing Therapy System (DPTS) and consists of the LIVE Catheter, a stimulation system with a Multipole Panel Accessory, an airflow sensor and a Heart Rate Data Capture Device. The catheter is intended for inclusion in the commercial product. The stimulation system with a Multipole Panel Accessory and a Heart Rate Data Capture Device is an interim component created to enable initial safety and feasibility testing of the Lungpacer DPTS concept.
- 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 jugular 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 jugular 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 jugular vein and stimulation of phrenic nerves
To determine whether in an anesthetized (sedated, intubated, and mechanically ventilated) patient the LIVE Catheter can be inserted percutaneously in the left jugular vein and, via the electrical stimulator, to transvenously stimulate one or both phrenic nerves causing the diaphragm to contract
Measured: through study completion, an average of 14 days
Secondary outcomes (1)
Absence of device related or procedure related adverse events
Assess subject for adverse events status up to 48 hours post procedure
Measured: through study completion, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start7 May 2018
- Primary completion30 Jun 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment
- 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
- Linda Clark, RN, Study director, Lungpacer Medical Inc.Adrian Ebner, MD, Principal investigator, Italian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659552
- Sponsor's protocol ID
- CLN-0012
- Status last verified
- Sep 2018
- First submitted
- 3 May 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Lungpacer may at any time publish the results of and information pertaining to the investigation subject only to compliance with regulatory requirements pertaining to patient protected health information
Publications
Michalek P, Kautznerova D. Combined use of ultrasonography and neurostimulation for therapeutic phrenic nerve block. Reg Anesth Pain Med. 2002 May-Jun;27(3):306-8. No abstract available.
PubMed 12016605Escher DJ, Furman S, Solomon N, Schwedel JB. Transvenous pacing of the phrenic nerves. Am Heart J. 1966 Aug;72(2):283-4. doi: 10.1016/0002-8703(66)90456-x. No abstract available.
PubMed 5915563Escher DJ, Ashley W, Ertag W, Parker B, Furman S, Robinson G. Clinical control of respiration by transvenous phrenic pacing. Trans Am Soc Artif Intern Organs. 1968;14:192-7. No abstract available.
PubMed 4882945Eisele JH, Noble MI, Katz J, Fung DL, Hickey RF. Bilateral phrenic-nerve block in man: technical problems and respiratory effects. Anesthesiology. 1972 Jul;37(1):64-9. doi: 10.1097/00000542-197207000-00012. No abstract available.
PubMed 5050104Aubier M, Murciano D, Lecocguic Y, Viires N, Jacquens Y, Squara P, Pariente R. Effect of hypophosphatemia on diaphragmatic contractility in patients with acute respiratory failure. N Engl J Med. 1985 Aug 15;313(7):420-4. doi: 10.1056/NEJM198508153130705.
PubMed 3860734Ishii K, Kurosawa H, Koyanagi H, Nakano K, Sakakibara N, Sato I, Noshiro M, Ohsawa M. Effects of bilateral transvenous diaphragm pacing on hemodynamic function in patients after cardiac operations. Experimental and clinical study. J Thorac Cardiovasc Surg. 1990 Jul;100(1):108-14.
PubMed 2366549Allen GM, McKenzie DK, Gandevia SC, Bass S. Reduced voluntary drive to breathe in asthmatic subjects. Respir Physiol. 1993 Jul;93(1):29-40. doi: 10.1016/0034-5687(93)90065-i.
PubMed 8367614Mulvey DA, Aquilina RJ, Elliott MW, Moxham J, Green M. Diaphragmatic dysfunction in neuralgic amyotrophy: an electrophysiologic evaluation of 16 patients presenting with dyspnea. Am Rev Respir Dis. 1993 Jan;147(1):66-71. doi: 10.1164/ajrccm/147.1.66.
PubMed 8420434McKenzie DK, Allen GM, Gandevia SC. Reduced voluntary drive to the human diaphragm at low lung volumes. Respir Physiol. 1996 Aug;105(1-2):69-76. doi: 10.1016/0034-5687(96)00021-7.
PubMed 8897652Oo T, Watt JW, Soni BM, Sett PK. Delayed diaphragm recovery in 12 patients after high cervical spinal cord injury. A retrospective review of the diaphragm status of 107 patients ventilated after acute spinal cord injury. Spinal Cord. 1999 Feb;37(2):117-22. doi: 10.1038/sj.sc.3100775.
PubMed 10065750Ahn B, Beaver T, Martin T, Hess P, Brumback BA, Ahmed S, Smith BK, Leeuwenburgh C, Martin AD, Ferreira LF. Phrenic nerve stimulation increases human diaphragm fiber force after cardiothoracic surgery. Am J Respir Crit Care Med. 2014 Oct 1;190(7):837-9. doi: 10.1164/rccm.201405-0993LE. No abstract available.
PubMed 25271750Germany R, Joseph S, James K, Kao A. A novel therapeutic approach for the treatment of central sleep apnea: The remede(R) system. Cardiovasc Revasc Med. 2014 Jun;15(4):235-9. doi: 10.1016/j.carrev.2014.03.007. Epub 2014 Mar 21.
PubMed 24726495Linhart M, Nielson A, Andrie RP, Mittmann-Braun EL, Stockigt F, Kreuz J, Nickenig G, Schrickel JW, Lickfett LM. Fluoroscopy of spontaneous breathing is more sensitive than phrenic nerve stimulation for detection of right phrenic nerve injury during cryoballoon ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2014 Aug;25(8):859-865. doi: 10.1111/jce.12431. Epub 2014 May 18.
PubMed 24724724
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using a Percutaneous Temporary Placement of a Transvenous Phrenic Nerve Stimulator for Diaphragm Pacing Using Jugular Access
- ClinicalTrials.gov ID
- NCT03659552
- Acronym / sponsor ID
- CLN-0012
- Conditions
- Ventilator-Induced Lung Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Lungpacer Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 7 May 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 6 Sep 2018 (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.
Study conducted to confirm phrenic nerve stimulation using the a transvenous Phrenic Nerve Stimulator in the left jugular vein.
Detailed description
The Lungpacer Jugular Access Feasibility System is a prototype for the Lungpacer Diaphragm Pacing Therapy System (DPTS) and consists of the LIVE Catheter, a stimulation system with a Multipole Panel Accessory, an airflow sensor and a Heart Rate Data Capture Device. The catheter is intended for inclusion in the commercial product. The stimulation system with a Multipole Panel Accessory and a Heart Rate Data Capture Device is an interim component created to enable initial safety and feasibility testing of the Lungpacer DPTS concept.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| 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 jugular vein. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older;
- Able and willing to give informed consent or whose legally authorized representative is able and willing to give informed consent;
- Able to undergo general anesthesia (sedation, intubation, and mechanical ventilation);
- Acceptable indication for atrial septal defect closure.
Key exclusion criteria (16 listed)
- Subject has an ejection fraction of < 30%
- Subject has a co-morbid illness or life expectancy < 2 years
- Subject has experienced an acute myocardial infarction 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 jugular 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 jugular vein and stimulation of phrenic nerves
Time frame: through study completion, an average of 14 days
To determine whether in an anesthetized (sedated, intubated, and mechanically ventilated) patient the LIVE Catheter can be inserted percutaneously in the left jugular vein and, via the electrical stimulator, to transvenously stimulate one or both phrenic nerves causing the diaphragm to contract
1 secondary outcome
Absence of device related or procedure related adverse events
Time frame: through study completion, an average of 14 days
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 6 Sep 2018.
- Background: PubMed 12016605Michalek P, Kautznerova D. Combined use of ultrasonography and neurostimulation for therapeutic phrenic nerve block. Reg Anesth Pain Med. 2002 May-Jun;27(3):306-8. No abstract available.
- Results publication: PubMed 5915563Escher DJ, Furman S, Solomon N, Schwedel JB. Transvenous pacing of the phrenic nerves. Am Heart J. 1966 Aug;72(2):283-4. doi: 10.1016/0002-8703(66)90456-x. No abstract available.
- Results publication: PubMed 4882945Escher DJ, Ashley W, Ertag W, Parker B, Furman S, Robinson G. Clinical control of respiration by transvenous phrenic pacing. Trans Am Soc Artif Intern Organs. 1968;14:192-7. No abstract available.
- Results publication: PubMed 5050104Eisele JH, Noble MI, Katz J, Fung DL, Hickey RF. Bilateral phrenic-nerve block in man: technical problems and respiratory effects. Anesthesiology. 1972 Jul;37(1):64-9. doi: 10.1097/00000542-197207000-00012. No abstract available.
- Results publication: PubMed 3860734Aubier M, Murciano D, Lecocguic Y, Viires N, Jacquens Y, Squara P, Pariente R. Effect of hypophosphatemia on diaphragmatic contractility in patients with acute respiratory failure. N Engl J Med. 1985 Aug 15;313(7):420-4. doi: 10.1056/NEJM198508153130705.
- Results publication: PubMed 2366549Ishii K, Kurosawa H, Koyanagi H, Nakano K, Sakakibara N, Sato I, Noshiro M, Ohsawa M. Effects of bilateral transvenous diaphragm pacing on hemodynamic function in patients after cardiac operations. Experimental and clinical study. J Thorac Cardiovasc Surg. 1990 Jul;100(1):108-14.
- Results publication: PubMed 8367614Allen GM, McKenzie DK, Gandevia SC, Bass S. Reduced voluntary drive to breathe in asthmatic subjects. Respir Physiol. 1993 Jul;93(1):29-40. doi: 10.1016/0034-5687(93)90065-i.
- Results publication: PubMed 8420434Mulvey DA, Aquilina RJ, Elliott MW, Moxham J, Green M. Diaphragmatic dysfunction in neuralgic amyotrophy: an electrophysiologic evaluation of 16 patients presenting with dyspnea. Am Rev Respir Dis. 1993 Jan;147(1):66-71. doi: 10.1164/ajrccm/147.1.66.
- Results publication: PubMed 8897652McKenzie DK, Allen GM, Gandevia SC. Reduced voluntary drive to the human diaphragm at low lung volumes. Respir Physiol. 1996 Aug;105(1-2):69-76. doi: 10.1016/0034-5687(96)00021-7.
- Results publication: PubMed 10065750Oo T, Watt JW, Soni BM, Sett PK. Delayed diaphragm recovery in 12 patients after high cervical spinal cord injury. A retrospective review of the diaphragm status of 107 patients ventilated after acute spinal cord injury. Spinal Cord. 1999 Feb;37(2):117-22. doi: 10.1038/sj.sc.3100775.
- Results publication: PubMed 25271750Ahn B, Beaver T, Martin T, Hess P, Brumback BA, Ahmed S, Smith BK, Leeuwenburgh C, Martin AD, Ferreira LF. Phrenic nerve stimulation increases human diaphragm fiber force after cardiothoracic surgery. Am J Respir Crit Care Med. 2014 Oct 1;190(7):837-9. doi: 10.1164/rccm.201405-0993LE. No abstract available.
- Results publication: PubMed 24726495Germany R, Joseph S, James K, Kao A. A novel therapeutic approach for the treatment of central sleep apnea: The remede(R) system. Cardiovasc Revasc Med. 2014 Jun;15(4):235-9. doi: 10.1016/j.carrev.2014.03.007. Epub 2014 Mar 21.
- Individual participant dataSharing planned: No. Lungpacer may at any time publish the results of and information pertaining to the investigation subject only to compliance with regulatory requirements pertaining to patient protected health information
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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 study director
Lungpacer Medical Inc.
Adrian Ebner, MD principal investigator
Italian Hospital
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 4 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 6 Sep 2018. 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 jugular vein and stimulation of phrenic nerves (time frame: through study completion, an average of 14 days). 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 NCT03659552, which also lists 13 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 6 Sep 2018.