Respiratory FailureNCT06609577
Personalized Ultrasound-Guided External Diaphragm Pacing to Improve Outcomes in Invasive Mechanically Ventilated Patients
A study testing Diaphragm Ultrasound-Guided External Diaphragm Pacing in people with Respiratory Failure and Mechanical Ventilation, run by Daishan Jiang at 1 site in China.
Trial summary
This study aims to explore whether personalized external diaphragm pacing (EDP) guided by real-time diaphragm ultrasound (DU) can improve outcomes for patients on invasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Respiratory Failure, Mechanical Ventilation
- What is being tested?
- Diaphragm Ultrasound-Guided External Diaphragm Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age undergoing invasive mechanical ventilation.
- Expected duration of mechanical ventilation ≥48 hours.
Who cannot join
- ICU expected length of stay less than 48 hours
- severe phrenic nerve or diaphragmatic injury that is unable to respond to diaphragmatic pacing.
- Patients who have received or are scheduled to receive other respiratory assistance or diaphragmatic pacing interventions.
- Patients with end-stage disease with an expected survival of \<6 months.
- Patients who are unable to be weaned from mechanical ventilation, such as patients with severe brain injury or paraplegia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
Daishan Jiang, 13773627637, jiangdaishan@ntu.edu.cn
About this study
Official title: Personalized Ultrasound Guided Pacing of the External Diaphragm to Improve Outcomes in Patients Undergoing Invasive Mechanical Ventilation: a Randomized Controlled Trial
This study aims to explore whether personalized external diaphragm pacing (EDP) guided by real-time diaphragm ultrasound (DU) can improve outcomes for patients on invasive mechanical ventilation. Diaphragm ultrasound will be used to assess each patient's diaphragm function and adjust the pacing intensity, creating a customized treatment plan. By using this individualized approach, the investigators hope to prevent diaphragm muscle weakening, which is a common issue during prolonged ventilation, and improve the chances of successful weaning from the ventilator. The study will also incorporate advanced diaphragm function metrics, such as diaphragm thickening fraction (DTF) and diaphragmatic rapid shallow breathing index (D-RSBI), to enhance the accuracy of treatment and improve patient recovery. This trial aims to improve overall outcomes and quality of care for patients requiring long-term mechanical ventilation.
Read the detailed description
This study investigates the efficacy of a personalized external diaphragm pacing (EDP) protocol, dynamically guided by diaphragm ultrasound (DU), in improving outcomes in mechanically ventilated patients. Unlike traditional EDP systems that use uniform pacing parameters, this study introduces an individualized approach that uses diaphragm function-monitored by real-time DU-to adjust pacing intensity, frequency, and duration for each patient. The goal is to optimize diaphragm activity, prevent muscle atrophy, and increase the likelihood of successful weaning from mechanical ventilation.
Key innovations in this study include the integration of novel diaphragmatic performance indicators such as diaphragmatic thickening fraction (DTF) and diaphragmatic rapid shallow breathing index (D-RSBI). These parameters will be used to assess diaphragm function more accurately than conventional methods and to inform adjustments to the stimulation regimen. By targeting ventilator-induced diaphragm dysfunction (VIDD) and preventing muscle weakness, this personalized approach aims to improve clinical outcomes, reduce ventilation time and facilitate recovery in critically ill patients.
The study will be a randomized controlled design comparing the effectiveness of personalized ultrasound-guided EDP to standard mechanical ventilation weaning protocols. Participants will be critically ill, mechanically ventilated patients requiring long-term respiratory support. Outcomes will include weaning success rate, time on mechanical ventilation, and overall patient survival and recovery rates. The trial aims to advance critical care protocols by integrating personalized technology to improve patient outcomes in the mechanical ventilation setting.
- Conditions
- Respiratory Failure, Mechanical Ventilation
- Being tested
- Diaphragm Ultrasound-Guided External Diaphragm Pacing
- Keywords
- External Diaphragm Pacing, Diaphragm Ultrasound, Mechanical Ventilation, Ventilator Weaning, Critical Care
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm Ultrasound-Guided External Diaphragm PacingDevice
This intervention, Diaphragm Ultrasound-Guided External Diaphragm Pacing (DU-EDP), is distinguished by its personalized approach, where diaphragm pacing is dynamically adjusted based on real-time diaphragm function measurements obtained through bedside diaphragm ultrasound (DU). Unlike standard external diaphragm pacing (EDP) interventions that use uniform pacing parameters, DU-EDP allows for the customization of pacing intensity, frequency, and duration for each patient. This intervention specifically integrates novel diaphragm function indices, such as diaphragm thickening fraction (DTF) and diaphragmatic rapid shallow breathing index (D-RSBI), to enhance precision in weaning from mechanical ventilation. The combination of these advanced metrics with real-time ultrasound guidance makes DU-EDP a highly individualized and innovative intervention for critically ill, mechanically ventilated patients.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Received standard mechanical ventilation withdrawal protocol without diaphragmatic external pacing |
| Invention group | Experimental | Diaphragm function was monitored by diaphragmatic ultrasound to personalize the intensity of diaphragm extracorporeal pacing. Receives: Device: Diaphragm Ultrasound-Guided External Diaphragm Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning Success Rate
The proportion of patients who are successfully weaned off mechanical ventilation for at least 48 hours without respiratory failure or reintubation.
Measured: Assessed 48 hours and 72 hours after weaning to ensure no need for reintubation or mechanical support.
Secondary outcomes (4)
Total Duration of Invasive Mechanical Ventilation
The total duration of invasive mechanical ventilation, measured in hours, from the initiation of mechanical ventilation post-randomization until successful weaning, defined as 48 consecutive hours of spontaneous breathing without any invasive mechanical ventilation support.
Measured: From the date of randomization until the time of successful weaning or patient discharge, whichever comes first, assessed up to 90 days after admission.
ICU Length of Stay
The total number of days the patient stays in the Intensive Care Unit (ICU), from the date of ICU admission until the date of ICU discharge.
Measured: From the date of randomization until the date of ICU discharge, assessed up to 90 days after admission..
30-Day and 90-Day Survival Rates
The survival rates of patients at 30 and 90 days after successful weaning, assessing outcomes.
Measured: Follow-up conducted at 30 days and 90 days after admission
Prevention of Diaphragm Atrophy
Changes in diaphragm thickness and prevention of muscle atrophy, assessed by ultrasound, comparing baseline values (at randomization) with measurements taken during treatment and at follow-up intervals. Measurements will be performed at predefined time points to evaluate the impact of treatment on diaphragm preservation.
Measured: From the date of randomization, assessed at baseline (within 24 hours post-randomization), on days 3 during treatment, and at the time of successful weaning, or until the date of patient discharge, , whichever comes first, assessed up to 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daishan Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daishan Jiang, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609577
- Sponsor's protocol ID
- 2021-L146
- Status last verified
- Oct 2024
- First submitted
- 17 Sep 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Ultrasound Guided Pacing of the External Diaphragm to Improve Outcomes in Patients Undergoing Invasive Mechanical Ventilation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06609577
- Acronym / sponsor ID
- 2021-L146
- Conditions
- Respiratory Failure, Mechanical Ventilation
- Keywords
- External Diaphragm Pacing, Diaphragm Ultrasound, Mechanical Ventilation, Ventilator Weaning, Critical Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Daishan JiangUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 24 Sep 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 explore whether personalized external diaphragm pacing (EDP) guided by real-time diaphragm ultrasound (DU) can improve outcomes for patients on invasive mechanical ventilation. Diaphragm ultrasound will be used to assess each patient's diaphragm function and adjust the pacing intensity, creating a customized treatment plan. By using this individualized approach, the investigators hope to prevent diaphragm muscle weakening, which is a common issue during prolonged ventilation, and improve the chances of successful weaning from the ventilator. The study will also incorporate advanced diaphragm function metrics, such as diaphragm thickening fraction (DTF) and diaphragmatic rapid shallow breathing index (D-RSBI), to enhance the accuracy of treatment and improve patient recovery. This trial aims to improve overall outcomes and quality of care for patients requiring long-term mechanical ventilation.
Detailed description
This study investigates the efficacy of a personalized external diaphragm pacing (EDP) protocol, dynamically guided by diaphragm ultrasound (DU), in improving outcomes in mechanically ventilated patients. Unlike traditional EDP systems that use uniform pacing parameters, this study introduces an individualized approach that uses diaphragm function-monitored by real-time DU-to adjust pacing intensity, frequency, and duration for each patient. The goal is to optimize diaphragm activity, prevent muscle atrophy, and increase the likelihood of successful weaning from mechanical ventilation.
Key innovations in this study include the integration of novel diaphragmatic performance indicators such as diaphragmatic thickening fraction (DTF) and diaphragmatic rapid shallow breathing index (D-RSBI). These parameters will be used to assess diaphragm function more accurately than conventional methods and to inform adjustments to the stimulation regimen. By targeting ventilator-induced diaphragm dysfunction (VIDD) and preventing muscle weakness, this personalized approach aims to improve clinical outcomes, reduce ventilation time and facilitate recovery in critically ill patients.
The study will be a randomized controlled design comparing the effectiveness of personalized ultrasound-guided EDP to standard mechanical ventilation weaning protocols. Participants will be critically ill, mechanically ventilated patients requiring long-term respiratory support. Outcomes will include weaning success rate, time on mechanical ventilation, and overall patient survival and recovery rates. The trial aims to advance critical care protocols by integrating personalized technology to improve patient outcomes in the mechanical ventilation setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Received standard mechanical ventilation withdrawal protocol without diaphragmatic external pacing |
| Invention group | Experimental | Device: Diaphragm Ultrasound-Guided External Diaphragm PacingDiaphragm function was monitored by diaphragmatic ultrasound to personalize the intensity of diaphragm extracorporeal pacing. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults ≥18 years of age undergoing invasive mechanical ventilation.
- Expected duration of mechanical ventilation ≥48 hours.
Key exclusion criteria (5 listed)
- ICU expected length of stay less than 48 hours
- severe phrenic nerve or diaphragmatic injury that is unable to respond to diaphragmatic pacing.
- Patients who have received or are scheduled to receive other respiratory assistance or diaphragmatic pacing interventions.
- Patients with end-stage disease with an expected survival of \<6 months.
- Patients who are unable to be weaned from mechanical ventilation, such as patients with severe brain injury or paraplegia.
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 |
|---|---|---|
| Diaphragm Ultrasound-Guided External Diaphragm PacingThis intervention, Diaphragm Ultrasound-Guided External Diaphragm Pacing (DU-EDP), is distinguished by its personalized approach, where diaphragm pacing is dynamically adjusted based on real-time diaphragm function measurements obtained through bedside diaphragm ultrasound (DU). Unlike standard external diaphragm pacing (EDP) interventions that use uniform pacing parameters, DU-EDP allows for the customization of pacing intensity, frequency, and duration for each patient. This intervention specifically integrates novel diaphragm function indices, such as diaphragm thickening fraction (DTF) and diaphragmatic rapid shallow breathing index (D-RSBI), to enhance precision in weaning from mechanical ventilation. The combination of these advanced metrics with real-time ultrasound guidance makes DU-EDP a highly individualized and innovative intervention for critically ill, mechanically ventilated patients. | Device | Invention group |
Primary outcome
Weaning Success Rate
Time frame: Assessed 48 hours and 72 hours after weaning to ensure no need for reintubation or mechanical support.
The proportion of patients who are successfully weaned off mechanical ventilation for at least 48 hours without respiratory failure or reintubation.
4 secondary outcomes
Total Duration of Invasive Mechanical Ventilation
Time frame: From the date of randomization until the time of successful weaning or patient discharge, whichever comes first, assessed up to 90 days after admission.
ICU Length of Stay
Time frame: From the date of randomization until the date of ICU discharge, assessed up to 90 days after admission..
30-Day and 90-Day Survival Rates
Time frame: Follow-up conducted at 30 days and 90 days after admission
Prevention of Diaphragm Atrophy
Time frame: From the date of randomization, assessed at baseline (within 24 hours post-randomization), on days 3 during treatment, and at the time of successful weaning, or until the date of patient discharge, , whichever comes first, assessed up to 90 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragm Ultrasound-Guided External Diaphragm Pacing in people with Respiratory Failure and Mechanical Ventilation, run by Daishan Jiang 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 5 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: looking for participants now, as of the sponsor's last update on 22 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daishan Jiang (+8613773627637, jiangdaishan@ntu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weaning Success Rate (time frame: Assessed 48 hours and 72 hours after weaning to ensure no need for reintubation or mechanical support.). 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 22 Oct 2024.