DiaphragmsNCT06436950
Electrical Phrenic Nerve Stimulation in Patients With VIDD
A study testing transcutaneous electrical phrenic nerve stimulation (TEPNS) in people with Diaphragms and Phrenic Nerves, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study aims to examine efficacy of transcutaneous electrical phrenic nerve stimulation (TEPNS) in ventilator-induced diaphragmatic dysfunction (VIDD). The investigators recruit VIDD patients, and randomly assign the patients into TEPNS group and control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragms, Phrenic Nerves
- What is being tested?
- transcutaneous electrical phrenic nerve stimulation (TEPNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2024to Jan 2026
- 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
- aged ≥ 18 years
- ventilated for at least 48 h with an expected stay of more than 7 days in the ICU
- diaphragm thickening fraction (DTF)< 25%
Who cannot join
- having a pacemaker
- cutaneous lesion that could interfere with probes
- previous diaphragmatic nerve paralysis
- body mass index > 35 kg/m2
- severe chronic obstructive pulmonary disease (FEV1/FVC<30%)
- pregnancy or lactation
- decision to withhold life-sustaining treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Zongyu Wang, Doctor, 86-010-82267028
About this study
Official title: Electrical Phrenic Nerve Stimulation in Patients With Ventilator-induced Diaphragm Dysfunction: a Randomized Controlled Study
This study aims to examine efficacy of transcutaneous electrical phrenic nerve stimulation (TEPNS) in ventilator-induced diaphragmatic dysfunction (VIDD). The investigators recruit VIDD patients, and randomly assign the patients into TEPNS group and control group. TEPNS group receives TEPNS twice a day for consecutive 5 days. Control group only receives usual care. The investigators collect diaphragm function indicators and outcomes to evaluate the efficacy.
Read the detailed description
Ventilator-induced diaphragmatic dysfunction (VIDD) is common in intensive care unit (ICU). There is a need of measurements to improve VIDD. The investigators hypothesize that transcutaneous electrical phrenic nerve stimulation (TEPNS) will increase diaphragmatic function. This study is a single centre, randomized controlled trial with control or treatment group in a 1:1 ratio. Eligible patients include aged ≥ 18 years, ventilated for at least 48 h with an expected stay of more than 7 days in the ICU, and diaphragm thickening fraction (DTF)< 25%. The patients are randomly allocated to either receiveTEPNS and usual care (TEPNS group) or usual care only (control group). Blind is not used. TEPNS is conducted twice a day for consecutive 5 days. Electrodes are applied to bilateral neck skin which phrenic nerve runs underneath. Clinical data are collected, including baseline characteristics, airway pressure, esophageal pressure, gastric pressure, ventilation days, ICU length of stay, 28-day mortality, etc.
- Conditions
- Diaphragms, Phrenic Nerves
- Being tested
- transcutaneous electrical phrenic nerve stimulation (TEPNS)
- Keywords
- Ventilator-induced diaphragmatic dysfunction, transcutaneous electrical phrenic nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical phrenic nerve stimulation (TEPNS)Device
TEPNS is conducted twice a day for consecutive 5 days. Electrodes are applied to bilateral neck skin which phrenic nerve runs underneath.
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous electrical phrenic nerve stimulation (TEPNS) group | Experimental | The patients in TEPNS group receive TEPNS and usual care. Receives: Device: transcutaneous electrical phrenic nerve stimulation (TEPNS) |
| Control group | No intervention | The patients in control group receive usual care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transdiaphragmatic pressure (Pdi)
Pdi=gastric pressure - esophageal pressure
Measured: Collected once a day after transcutaneous electrical phrenic nerve stimulation (TEPNS) for consecutive 5 days
Secondary outcomes (5)
Airway pressure, esophageal pressure, gastric pressure, airway occlusion pressure, driving pressure, transpulmonary pressure
Determined from respiratory mechanics indicators provided by ventilator or calculated from them
Measured: Collected once a day after TEPNS for consecutive 5 days
Esophageal pressure-time product
Determined from respiratory mechanics indicators provided by ventilator
Measured: Collected once a day after TEPNS for consecutive 5 days
Ventilation days
Mechanical ventilation days in 28 days after enrollment
Measured: Collected at 28 days after enrollment
Length of ICU stay
Days of ICU stay in 28 days after enrollment
Measured: Collected at 28 days after enrollment
28-day mortality
Survival outcomes
Measured: Collected at 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start4 Jun 2024
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DiaphragmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Transcutaneous electrical phrenic nerve stimulation (TEPNS) group: TEPNS+usual care Control group: usual care
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Zongyu, Peking University Third Hospital
- Investigators
- Zongyu Wang, Dr., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436950
- Sponsor's protocol ID
- TEPNS_01
- Status last verified
- Jun 2024
- First submitted
- 20 May 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bao Q, Chen L, Chen X, Li T, Xie C, Zou Z, Huang C, Zhi Y, He Z. The effects of external diaphragmatic pacing on diaphragm function and weaning outcomes of critically ill patients with mechanical ventilation: a prospective randomized study. Ann Transl Med. 2022 Oct;10(20):1100. doi: 10.21037/atm-22-4145.
PubMed 36388825Medrinal C, Machefert M, Lamia B, Bonnevie T, Gravier FE, Hilfiker R, Prieur G, Combret Y. Transcutaneous electrical diaphragmatic stimulation in mechanically ventilated patients: a randomised study. Crit Care. 2023 Aug 30;27(1):338. doi: 10.1186/s13054-023-04597-1.
PubMed 37649092O'Rourke J, Sotak M, Curley GF, Doolan A, Henlin T, Mullins G, Tyll T, Omlie W, Ranieri MV. Initial Assessment of the Percutaneous Electrical Phrenic Nerve Stimulation System in Patients on Mechanical Ventilation. Crit Care Med. 2020 May;48(5):e362-e370. doi: 10.1097/CCM.0000000000004256.
PubMed 32191413Sotak M, Roubik K, Henlin T, Tyll T. Phrenic nerve stimulation prevents diaphragm atrophy in patients with respiratory failure on mechanical ventilation. BMC Pulm Med. 2021 Oct 8;21(1):314. doi: 10.1186/s12890-021-01677-2.
PubMed 34625059Poulard T, Bachasson D, Fosse Q, Nierat MC, Hogrel JY, Demoule A, Gennisson JL, Dres M. Poor Correlation between Diaphragm Thickening Fraction and Transdiaphragmatic Pressure in Mechanically Ventilated Patients and Healthy Subjects. Anesthesiology. 2022 Jan 1;136(1):162-175. doi: 10.1097/ALN.0000000000004042.
PubMed 34788380Goligher EC, Dres M, Patel BK, Sahetya SK, Beitler JR, Telias I, Yoshida T, Vaporidi K, Grieco DL, Schepens T, Grasselli G, Spadaro S, Dianti J, Amato M, Bellani G, Demoule A, Fan E, Ferguson ND, Georgopoulos D, Guerin C, Khemani RG, Laghi F, Mercat A, Mojoli F, Ottenheijm CAC, Jaber S, Heunks L, Mancebo J, Mauri T, Pesenti A, Brochard L. Lung- and Diaphragm-Protective Ventilation. Am J Respir Crit Care Med. 2020 Oct 1;202(7):950-961. doi: 10.1164/rccm.202003-0655CP.
PubMed 32516052
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Phrenic Nerve Stimulation in Patients With Ventilator-induced Diaphragm Dysfunction: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06436950
- Acronym / sponsor ID
- TEPNS_01
- Conditions
- Diaphragms, Phrenic Nerves
- Keywords
- Ventilator-induced diaphragmatic dysfunction, transcutaneous electrical phrenic nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 31 May 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.
This study aims to examine efficacy of transcutaneous electrical phrenic nerve stimulation (TEPNS) in ventilator-induced diaphragmatic dysfunction (VIDD). The investigators recruit VIDD patients, and randomly assign the patients into TEPNS group and control group. TEPNS group receives TEPNS twice a day for consecutive 5 days. Control group only receives usual care. The investigators collect diaphragm function indicators and outcomes to evaluate the efficacy.
Detailed description
Ventilator-induced diaphragmatic dysfunction (VIDD) is common in intensive care unit (ICU). There is a need of measurements to improve VIDD. The investigators hypothesize that transcutaneous electrical phrenic nerve stimulation (TEPNS) will increase diaphragmatic function. This study is a single centre, randomized controlled trial with control or treatment group in a 1:1 ratio. Eligible patients include aged ≥ 18 years, ventilated for at least 48 h with an expected stay of more than 7 days in the ICU, and diaphragm thickening fraction (DTF)< 25%. The patients are randomly allocated to either receiveTEPNS and usual care (TEPNS group) or usual care only (control group). Blind is not used. TEPNS is conducted twice a day for consecutive 5 days. Electrodes are applied to bilateral neck skin which phrenic nerve runs underneath. Clinical data are collected, including baseline characteristics, airway pressure, esophageal pressure, gastric pressure, ventilation days, ICU length of stay, 28-day mortality, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Transcutaneous electrical phrenic nerve stimulation (TEPNS) group: TEPNS+usual care Control group: usual care
| Arm | Type | Receives |
|---|---|---|
| transcutaneous electrical phrenic nerve stimulation (TEPNS) group | Experimental | Device: transcutaneous electrical phrenic nerve stimulation (TEPNS)The patients in TEPNS group receive TEPNS and usual care. |
| Control group | No intervention | –The patients in control group receive usual care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged ≥ 18 years
- ventilated for at least 48 h with an expected stay of more than 7 days in the ICU
- diaphragm thickening fraction (DTF)< 25%
Key exclusion criteria (7 listed)
- having a pacemaker
- cutaneous lesion that could interfere with probes
- previous diaphragmatic nerve paralysis
- body mass index > 35 kg/m2
- severe chronic obstructive pulmonary disease (FEV1/FVC<30%)
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 |
|---|---|---|
| transcutaneous electrical phrenic nerve stimulation (TEPNS)TEPNS is conducted twice a day for consecutive 5 days. Electrodes are applied to bilateral neck skin which phrenic nerve runs underneath. | Device | transcutaneous electrical phrenic nerve stimulation (TEPNS) group |
Primary outcome
Transdiaphragmatic pressure (Pdi)
Time frame: Collected once a day after transcutaneous electrical phrenic nerve stimulation (TEPNS) for consecutive 5 days
Pdi=gastric pressure - esophageal pressure
5 secondary outcomes
Airway pressure, esophageal pressure, gastric pressure, airway occlusion pressure, driving pressure, transpulmonary pressure
Time frame: Collected once a day after TEPNS for consecutive 5 days
Esophageal pressure-time product
Time frame: Collected once a day after TEPNS for consecutive 5 days
Ventilation days
Time frame: Collected at 28 days after enrollment
Length of ICU stay
Time frame: Collected at 28 days after enrollment
28-day mortality
Time frame: Collected at 28 days after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Background: PubMed 36388825Bao Q, Chen L, Chen X, Li T, Xie C, Zou Z, Huang C, Zhi Y, He Z. The effects of external diaphragmatic pacing on diaphragm function and weaning outcomes of critically ill patients with mechanical ventilation: a prospective randomized study. Ann Transl Med. 2022 Oct;10(20):1100. doi: 10.21037/atm-22-4145.
- Background: PubMed 37649092Medrinal C, Machefert M, Lamia B, Bonnevie T, Gravier FE, Hilfiker R, Prieur G, Combret Y. Transcutaneous electrical diaphragmatic stimulation in mechanically ventilated patients: a randomised study. Crit Care. 2023 Aug 30;27(1):338. doi: 10.1186/s13054-023-04597-1.
- Background: PubMed 32191413O'Rourke J, Sotak M, Curley GF, Doolan A, Henlin T, Mullins G, Tyll T, Omlie W, Ranieri MV. Initial Assessment of the Percutaneous Electrical Phrenic Nerve Stimulation System in Patients on Mechanical Ventilation. Crit Care Med. 2020 May;48(5):e362-e370. doi: 10.1097/CCM.0000000000004256.
- Background: PubMed 34625059Sotak M, Roubik K, Henlin T, Tyll T. Phrenic nerve stimulation prevents diaphragm atrophy in patients with respiratory failure on mechanical ventilation. BMC Pulm Med. 2021 Oct 8;21(1):314. doi: 10.1186/s12890-021-01677-2.
- Background: PubMed 34788380Poulard T, Bachasson D, Fosse Q, Nierat MC, Hogrel JY, Demoule A, Gennisson JL, Dres M. Poor Correlation between Diaphragm Thickening Fraction and Transdiaphragmatic Pressure in Mechanically Ventilated Patients and Healthy Subjects. Anesthesiology. 2022 Jan 1;136(1):162-175. doi: 10.1097/ALN.0000000000004042.
- Background: PubMed 32516052Goligher EC, Dres M, Patel BK, Sahetya SK, Beitler JR, Telias I, Yoshida T, Vaporidi K, Grieco DL, Schepens T, Grasselli G, Spadaro S, Dianti J, Amato M, Bellani G, Demoule A, Fan E, Ferguson ND, Georgopoulos D, Guerin C, Khemani RG, Laghi F, Mercat A, Mojoli F, Ottenheijm CAC, Jaber S, Heunks L, Mancebo J, Mauri T, Pesenti A, Brochard L. Lung- and Diaphragm-Protective Ventilation. Am J Respir Crit Care Med. 2020 Oct 1;202(7):950-961. doi: 10.1164/rccm.202003-0655CP.
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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.
Zongyu Wang, Dr. principal investigator
Peking University Third 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 transcutaneous electrical phrenic nerve stimulation (TEPNS) in people with Diaphragms and Phrenic Nerves, run by Peking University Third Hospital 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 3 inclusion and 7 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 12 Nov 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 Zongyu Wang, Dr. (008601082267028, wangzy1976@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transdiaphragmatic pressure (Pdi) (time frame: Collected once a day after transcutaneous electrical phrenic nerve stimulation (TEPNS) for consecutive 5 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 NCT06436950, which also lists 6 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 12 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.