ARDS, HumanNCT06572280
Non-invasive Phrenic Nerve Stimulation in ARDS Patient
A study testing PNS group in people with ARDS, Human and Ventilator-Induced Lung Injury, run by Southeast University, China at 1 site in China.
Trial summary
Reduced diaphragmatic activity during mechanical ventilation can lead to diaphragmatic disuse atrophy, atelectasis, increased lung stress and strain, and hemodynamic impairment. This, in turn, may prolong the duration of mechanical ventilation, make weaning more difficult, and even increase mortality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ARDS, Human, Ventilator-Induced Lung Injury, Diaphragm Injury
- What is being tested?
- PNS group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 Jan 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult ARDS patients undergoing controlled mechanical ventilation
- The duration of endotracheal intubation < 48 hrs
Who cannot join
- Neurological condition affecting motor neuron or muscle (e.g. ALS)
- Paralysis of the phrenic nerve
- Proven or suspected spinal cord injury
- Conditions that limit diaphragm movement
- Patients with Implanted cardiac support systems (pacemaker, implanted defibrillator)
- Patients with implanted medical pumps
Show all 10Show fewer
- Pregnancy
- Patients with skin lesions, infections or strictures in throat/neck area
- Patients with metallic implants
- Refusal to sign informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, 210009
ling liu, phD, 15901599659, 18826401594@163.com
About this study
Official title: Non-invasive Phrenic Nerve Stimulation in ARDS Patients - a Feasibility Study
Reduced diaphragmatic activity during mechanical ventilation can lead to diaphragmatic disuse atrophy, atelectasis, increased lung stress and strain, and hemodynamic impairment. This, in turn, may prolong the duration of mechanical ventilation, make weaning more difficult, and even increase mortality. Synchronizing phrenic nerve stimulation to promote diaphragmatic activity may prevent ventilator-induced lung injury and ventilator-induced diaphragm dysfunction, thereby improving patient outcomes. Surgically implanted phrenic nerve stimulation has been used in certain neurological disorders, but the effects of percutaneous non-invasive synchronized phrenic nerve stimulation in patients with ARDS undergoing mechanical ventilation remain unclear and require further investigation.
Read the detailed description
Mechanical ventilation is an important treatment for patients with acute hypoxemic respiratory failure (AHRF). However, reduced diaphragmatic activity during mechanical ventilation can lead to diaphragmatic disuse atrophy, atelectasis, increased lung stress and strain, and hemodynamic impairment. This, in turn, may prolong the duration of mechanical ventilation, make weaning more difficult, and even increase mortality in these patients. In patients with AHRF undergoing mechanical ventilation, maintaining moderate spontaneous breathing under lung and diaphragm protective ventilation remains challenging. Synchronizing phrenic nerve stimulation to promote diaphragmatic activity may prevent ventilator-induced lung injury (VILI) and ventilator-induced diaphragm dysfunction (VIDD), thereby improving patient outcomes. Surgically implanted phrenic nerve stimulation has been used in certain neurological disorders, but the effects of percutaneous non-invasive synchronized phrenic nerve stimulation in patients with acute respiratory distress syndrome (ARDS) undergoing mechanical ventilation remain unclear and require further investigation.
- Being tested
- PNS group
- Keywords
- ARDS, diaphragm injury, mechanical ventilation
- Medical subject headings
- Respiratory Distress Syndrome, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNS groupDevice
non-invasive phrenic nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| PNS group | Experimental | Electrical stimulation of the phrenic nerve in ARDS patients. Receives: Device: PNS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of enough Tidal volume
Percentage of stimulated breaths above the cut-off target tidal volume (3-6 ml/kg ideal body weigh) out of the total number of stimulated breaths
Measured: Procedure (from enrollment to extubation)
The speed of successful non-invasive electrical stimulation deployment
Time between first successful electrical phrenic stimulation and identification of the optimal stimulation locus in seconds
Measured: Procedure (from enrollment to extubation)
Secondary outcomes (6)
Driving pressure
driving pressure was measured in the volume-controlled mode and calculated as the difference between plateau pressure and positive end-expiratory pressure
Measured: Procedure (from enrollment to extubation)
Diaphragm thickening fraction
Diaphragm thickening fraction measured with ultrasound of the diaphragm.
Measured: up to 28 days
Diaphragm excursion
Diaphragm excursion measured with ultrasound of the diaphragm.
Measured: up to 28 days
Maximal inspiratory pressure (MIP)
MIP is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.
Measured: Procedure (from enrollment to extubation)
ventilation distribution
ventilation distribution was measured by EIT
Measured: Procedure (from enrollment to extubation)
Respiratory system compliance
Respiratory system compliance is calculated as the ratio of tidal volume to the difference between plateau pressure and positive end-expiratory pressure.
Measured: Procedure (from enrollment to extubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Aug 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- ling liu, phD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572280
- Sponsor's protocol ID
- NPES-diaphragm protection
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 27 Aug 2024
- 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Phrenic Nerve Stimulation in ARDS Patients - a Feasibility Study
- ClinicalTrials.gov ID
- NCT06572280
- Acronym / sponsor ID
- NPES-diaphragm protection
- Keywords
- ARDS, diaphragm injury, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 27 Aug 2024 (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.
Reduced diaphragmatic activity during mechanical ventilation can lead to diaphragmatic disuse atrophy, atelectasis, increased lung stress and strain, and hemodynamic impairment. This, in turn, may prolong the duration of mechanical ventilation, make weaning more difficult, and even increase mortality. Synchronizing phrenic nerve stimulation to promote diaphragmatic activity may prevent ventilator-induced lung injury and ventilator-induced diaphragm dysfunction, thereby improving patient outcomes. Surgically implanted phrenic nerve stimulation has been used in certain neurological disorders, but the effects of percutaneous non-invasive synchronized phrenic nerve stimulation in patients with ARDS undergoing mechanical ventilation remain unclear and require further investigation.
Detailed description
Mechanical ventilation is an important treatment for patients with acute hypoxemic respiratory failure (AHRF). However, reduced diaphragmatic activity during mechanical ventilation can lead to diaphragmatic disuse atrophy, atelectasis, increased lung stress and strain, and hemodynamic impairment. This, in turn, may prolong the duration of mechanical ventilation, make weaning more difficult, and even increase mortality in these patients. In patients with AHRF undergoing mechanical ventilation, maintaining moderate spontaneous breathing under lung and diaphragm protective ventilation remains challenging. Synchronizing phrenic nerve stimulation to promote diaphragmatic activity may prevent ventilator-induced lung injury (VILI) and ventilator-induced diaphragm dysfunction (VIDD), thereby improving patient outcomes. Surgically implanted phrenic nerve stimulation has been used in certain neurological disorders, but the effects of percutaneous non-invasive synchronized phrenic nerve stimulation in patients with acute respiratory distress syndrome (ARDS) undergoing mechanical ventilation remain unclear and require further investigation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PNS group | Experimental | Device: PNS groupElectrical stimulation of the phrenic nerve in ARDS patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adult ARDS patients undergoing controlled mechanical ventilation
- The duration of endotracheal intubation < 48 hrs
Key exclusion criteria (10 listed)
- Neurological condition affecting motor neuron or muscle (e.g. ALS)
- Paralysis of the phrenic nerve
- Proven or suspected spinal cord injury
- Conditions that limit diaphragm movement
- Patients with Implanted cardiac support systems (pacemaker, implanted defibrillator)
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 |
|---|---|---|
| PNS groupnon-invasive phrenic nerve stimulation | Device | PNS group |
Primary outcome
Frequency of enough Tidal volume
Time frame: Procedure (from enrollment to extubation)
Percentage of stimulated breaths above the cut-off target tidal volume (3-6 ml/kg ideal body weigh) out of the total number of stimulated breaths
The speed of successful non-invasive electrical stimulation deployment
Time frame: Procedure (from enrollment to extubation)
Time between first successful electrical phrenic stimulation and identification of the optimal stimulation locus in seconds
6 secondary outcomes
Driving pressure
Time frame: Procedure (from enrollment to extubation)
Diaphragm thickening fraction
Time frame: up to 28 days
Diaphragm excursion
Time frame: up to 28 days
Maximal inspiratory pressure (MIP)
Time frame: Procedure (from enrollment to extubation)
ventilation distribution
Time frame: Procedure (from enrollment to extubation)
Respiratory system compliance
Time frame: Procedure (from enrollment to extubation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- 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.
ling liu, phD principal investigator
Zhongda 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 PNS group in people with ARDS, Human and Ventilator-Induced Lung Injury, run by Southeast University, China at 1 site in China.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ling liu, phD (15901599659, 18826401594@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of enough Tidal volume (time frame: Procedure (from enrollment to extubation)). 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?
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 27 Aug 2024.