Acute Respiratory Failure Requiring IntubationNCT06756204
A Study on the Assessment of Difficult Weaning in Patients With Acute Respiratory Failure Undergoing Mechanical Ventilation Based on Machine Learning EIT-pendelluft: A Multicenter Retrospective Study.
An observational study of Acute Respiratory Failure Requiring Intubation, run by Ruijin Hospital at 1 site in China.
Trial summary
Invasive mechanical ventilation (IMV) is a common method used in the ICU to assist breathing and promote gas exchange. When a patient's condition improves, the weaning process (WP) should be initiated. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Respiratory Failure Requiring Intubation
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2026
- How long will I take part?
- 28 Days
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Department of Critical Care Medicine is recruiting hospitalized patients with severe acute respiratory failure requiring mechanical ventilation.
Who may be able to join
- 1. It is anticipated that a spontaneous breathing trial (SBT) will be conducted within 48 hours for patients with acute respiratory failure who are receiving pressure support ventilation (PSV).
- 2. Prolonged mechanical ventilation time (ventilation for ≥7 days).
Who cannot join
- 1. Cardiac and pulmonary instability. 2. Severe neurological deficits. 3. Bilateral phrenic nerve injury. 4. Previously admitted to the ICU with a life expectancy of less than three months.
- 5. Presence of contraindications for EIT examination.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care Medicine,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai,China.
Shanghai, Shanghai Municipality, 200025
About this study
Invasive mechanical ventilation (IMV) is a common method used in the ICU to assist breathing and promote gas exchange. When a patient's condition improves, the weaning process (WP) should be initiated. There is a risk of failure during weaning, especially for elderly patients with prolonged ICU stays or those suffering from respiratory or neuromuscular diseases. Therefore, accurately assessing the likelihood of successful weaning before initiating the process holds significant clinical importance.
The weaning process involves gradually reducing the intensity of ventilatory support, continuous control of respiratory failure, restoration of oxygen indices, reduction of inhaled oxygen concentration, improvement of various laboratory indicators, and objective clinical assessment. Weaning is generally categorized into three types: simple weaning, difficult weaning, and delayed weaning. Successful weaning is defined as a patient breathing for 48 hours without respiratory support and without signs of respiratory failure. If a patient fails the spontaneous breathing trial (SBT) and requires re-intubation within 48 hours or dies within 48 hours, it is considered a failure of weaning. Successful extubation is defined as stable breathing for 48 hours or more without the need for IMV after weaning. It is related to multiple factors, including the patient's general condition, control of related diseases, ventilation-perfusion ratio, cough and sputum clearance ability, lung compliance, and diaphragm function. Timely assessment of these factors is crucial for determining the optimal timing for weaning, thereby avoiding premature weaning or unnecessarily prolonging IMV to reduce complications and prevent adverse clinical outcomes. Recent studies have identified new predictive factors, but their predictive performance has not been satisfactory. Various methods have been attempted in clinical practice to predict successful weaning, such as using pressure support ventilation or T-tube for SBT. However, there are numerous factors influencing the success of weaning, some of which have not been adequately considered, and published clinical studies have not yielded satisfactory results. Currently, the most widely used SBT trial still has a failure rate of approximately 20%.
This study intends to apply electrical impedance tomography (EIT), which can be used at the bedside, as a non-radiative, real-time monitoring and diagnostic tool. It is currently widely used to monitor regional lung ventilation distribution, lung volume, and respiratory mechanical characteristics, assisting clinicians in more accurately observing real changes in lung ventilation and lung volume at the bedside. This study aims to monitor patients' respiratory oscillations through EIT, clarify their correlation with difficulties, and use it as a convenient, practical, and effective new predictive factor for assessing the success rate of weaning in patients with severe acute respiratory failure.
- Keywords
- Electrical impedance tomography, pendellufft, invasive mechanical ventilation, weaning process
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pendellufft group | Patients with severe acute respiratory failure undergoing mechanical ventilation were found to have pendelluft by EIT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 28-day successful extubation rate of the two groups of study subjects
The 28-day successful extubation rate of the two groups was compared
Measured: From enrollment to the end of treatment at 28-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Failure Requiring IntubationStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 216 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756204
- Sponsor's protocol ID
- 2024505
- Status last verified
- Dec 2024
- First submitted
- 25 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Assessment of Difficult Weaning in Patients With Acute Respiratory Failure Undergoing Mechanical Ventilation Based on Machine Learning EIT-pendelluft: A Multicenter Retrospective Study.
- ClinicalTrials.gov ID
- NCT06756204
- Acronym / sponsor ID
- 2024505
- Keywords
- Electrical impedance tomography, pendellufft, invasive mechanical ventilation, weaning process
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Jan 2025 (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.
Invasive mechanical ventilation (IMV) is a common method used in the ICU to assist breathing and promote gas exchange. When a patient's condition improves, the weaning process (WP) should be initiated. There is a risk of failure during weaning, especially for elderly patients with prolonged ICU stays or those suffering from respiratory or neuromuscular diseases. Therefore, accurately assessing the likelihood of successful weaning before initiating the process holds significant clinical importance.
The weaning process involves gradually reducing the intensity of ventilatory support, continuous control of respiratory failure, restoration of oxygen indices, reduction of inhaled oxygen concentration, improvement of various laboratory indicators, and objective clinical assessment. Weaning is generally categorized into three types: simple weaning, difficult weaning, and delayed weaning. Successful weaning is defined as a patient breathing for 48 hours without respiratory support and without signs of respiratory failure. If a patient fails the spontaneous breathing trial (SBT) and requires re-intubation within 48 hours or dies within 48 hours, it is considered a failure of weaning. Successful extubation is defined as stable breathing for 48 hours or more without the need for IMV after weaning. It is related to multiple factors, including the patient's general condition, control of related diseases, ventilation-perfusion ratio, cough and sputum clearance ability, lung compliance, and diaphragm function. Timely assessment of these factors is crucial for determining the optimal timing for weaning, thereby avoiding premature weaning or unnecessarily prolonging IMV to reduce complications and prevent adverse clinical outcomes. Recent studies have identified new predictive factors, but their predictive performance has not been satisfactory. Various methods have been attempted in clinical practice to predict successful weaning, such as using pressure support ventilation or T-tube for SBT. However, there are numerous factors influencing the success of weaning, some of which have not been adequately considered, and published clinical studies have not yielded satisfactory results. Currently, the most widely used SBT trial still has a failure rate of approximately 20%.
This study intends to apply electrical impedance tomography (EIT), which can be used at the bedside, as a non-radiative, real-time monitoring and diagnostic tool. It is currently widely used to monitor regional lung ventilation distribution, lung volume, and respiratory mechanical characteristics, assisting clinicians in more accurately observing real changes in lung ventilation and lung volume at the bedside. This study aims to monitor patients' respiratory oscillations through EIT, clarify their correlation with difficulties, and use it as a convenient, practical, and effective new predictive factor for assessing the success rate of weaning in patients with severe acute respiratory failure.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pendellufft group | – | –Patients with severe acute respiratory failure undergoing mechanical ventilation were found to have pendelluft by EIT. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Department of Critical Care Medicine is recruiting hospitalized patients with severe acute respiratory failure requiring mechanical ventilation.
Key inclusion criteria (2 listed)
- 1. It is anticipated that a spontaneous breathing trial (SBT) will be conducted within 48 hours for patients with acute respiratory failure who are receiving pressure support ventilation (PSV).
- 2. Prolonged mechanical ventilation time (ventilation for ≥7 days).
Key exclusion criteria (2 listed)
- 1. Cardiac and pulmonary instability. 2. Severe neurological deficits. 3. Bilateral phrenic nerve injury. 4. Previously admitted to the ICU with a life expectancy of less than three months.
- 5. Presence of contraindications for EIT examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The 28-day successful extubation rate of the two groups of study subjects
Time frame: From enrollment to the end of treatment at 28-day
The 28-day successful extubation rate of the two groups was compared
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 1 Jan 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure Requiring Intubation, run by Ruijin 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 1 Jan 2025. 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?
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?
The 28-day successful extubation rate of the two groups of study subjects (time frame: From enrollment to the end of treatment at 28-day). 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 1 Jan 2025.