Weaning FailureNCT07003672
Role of Regional Lung Compliance and Dynamic Transpulmonary Driving Pressure in the Liberation Difficulty in Tracheostomized Patients Receiving Prolonged Mechanical Ventilation
An observational study of Weaning Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This project focuses on the analysis of the correlation between transpulmonary driving pressure and uneven lung ventilation and regional lung compliance in patients using prolonged mechanical ventilation (PMV), in order to understand the clinical occurrence of failure of the final spontaneous breathing test and… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Weaning Failure
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Jan 2025to 30 Jun 2028
- How long will I take part?
- 16 Weeks
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This project hopes to conduct research on patients on prolonged ventilator use (PMV). This group is an important manifestation of chronic severe illness and prolonged use of respirators after acute illness.
Who may be able to join
- Post-tracheostomy patients who are transferred to the subacute respiratory care ward of National Taiwan University Hospital must use respirators for at least 14 days;
- Be at least 20 years old;
- The oxygen concentration required when using the respirator does not exceed 50%
Who cannot join
- The vital signs are unstable or require continuous use of vasopressors;
- Pregnancy;
- Chronic obstructive pulmonary disease or asthma;
- Those who have contraindications to the placement of esophageal pressure balloons, such as abnormal blood coagulation, esophageal varices, and those who have undergone esophageal or gastric surgery in the past six months;
- Those who have contraindications to the use of electrical impedance tomography, such as heart rhythm regulators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jih-Shuin Jerng, MD, PhD, Principal Investigator contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Jih-Shuin Jerng, MD, PhD, +886-2-23123456 ext. Ext. 263532, jsjerng@ntu.edu.tw
About this study
This project focuses on the analysis of the correlation between transpulmonary driving pressure and uneven lung ventilation and regional lung compliance in patients using prolonged mechanical ventilation (PMV), in order to understand the clinical occurrence of failure of the final spontaneous breathing test and inability to breathe. Respiratory physiology impairments in patients successfully discharged from respirators.
Read the detailed description
This plan outlines a research project focusing on patients with prolonged ventilator use (PMV), an important manifestation of chronic critical illness (CCI) characterized by prolonged ventilator use after acute illness. This research team has sufficient experience in PMV clinical research and observed that even in the standardized process of weaning from the ventilator, the proportion of patients who successfully weaned from the ventilator was still low. Only 57.9% of the patients were successfully weaned from the ventilator, while the others were Transfer to a long-term care facility or face adverse outcomes. This research project aims to identify important respiratory physiology factors that increase the chances of PMV patients being weaned from ventilators and address a key unanswered question. PMV is often the result of CCI and involves complex clinical challenges such as organ dysfunction, dysregulated immune response, and recurrent infections. Patients' responses to disengagement training vary, often requiring individualized strategies. Conventional lung monitoring using electrical impedance imaging (EIT) can be used to quantify regional hyperinflation and collapse at each level. This method is based on pixel-level changes in respiratory system compliance and depends on whether the patient is fixed or Measured driving pressure, airway pressure (Paw), esophageal pressure (Pes) while accounting for assisted ventilation; EIT monitoring to quantify lung overinflation and collapse Use intrathoracic driving pressure (ΔPLdyn) changes to assess lung compliance at the pixel level change. We will use currently available methods, combining EIT and Pes monitoring, to measure ΔPLdyn in PMV patients. It has been shown in the literature that using ΔPLdyn rather than dynamic airway driving pressure to quantify regional lung overinflation and collapse, that is, compliance changes, is physiologically reasonable and clinically feasible. This method may represent a more accurate assessment of regional lung mechanics associated with the lowest inspiratory effort in the assisted ventilation setting. We hope to understand the changes in regional lung ventilation and compliance of PMV patients during the respirator weaning test through a series of clinical respiratory physiology research processes, in order to find ways to improve the patient's chances of weaning off.
- Conditions
- Weaning Failure
- Keywords
- prolonged mechanical ventilation，PMV, chronic critical illness，CCI
What is being measured
The primary outcome is the main question the study is designed to answer.
SIMV+PSV（Synchronized intermittent mandatory ventilation + pressure support ventilation)
Timing points for measurement in respiratory physiology assessment include: 1) once when the ventilator is reduced to the lowest supported SIMV+PV mode, and once in the first and fourth hours of the four-hour weaning test period (collar mask), for a total of three times. The measurement tools were the EIT measuring instrument (PulmoVista 500, Dräger Medical, Lübeck, Germany) and the IC measuring instrument Engström Carestation (GE Healthcare, Madison, WI, USA) available in the Department of Respiratory Therapy of our hospital. The methods for measuring EIT 62,64 and IC 57 were as described in the literature30. Tubes will also be installed and connected to the instruments provided by the respiratory therapy department. The esophageal pressure measurement tube is an esophageal balloon similar to a nasogastric tube. The esophageal balloon used in this study has two functions of pressure measurement and nasogastric tube (Nutrivent®), which can be placed for 30 days and has the function of
Measured: ．up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start16 Jan 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 16 Weeks
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003672
- Sponsor's protocol ID
- 202401042RINB
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This project focuses on analyzing the correlation between transpulmonary driving pressure, lung ventilation heterogeneity and regional lung compliance in patients with prolonged mechanical ventilation (PMV), so as to understand the clinical causes of failure of the final spontaneous breathing test and inability to breathe. Physiological aspects of breathing in patients successfully discharged from hospital off ventilators.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Regional Lung Compliance and Dynamic Transpulmonary Driving Pressure in the Liberation Difficulty in Tracheostomized Patients Receiving Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07003672
- Acronym / sponsor ID
- 202401042RINB
- Conditions
- Weaning Failure
- Keywords
- prolonged mechanical ventilation，PMV, chronic critical illness，CCI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 Jun 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.
This project focuses on the analysis of the correlation between transpulmonary driving pressure and uneven lung ventilation and regional lung compliance in patients using prolonged mechanical ventilation (PMV), in order to understand the clinical occurrence of failure of the final spontaneous breathing test and inability to breathe. Respiratory physiology impairments in patients successfully discharged from respirators.
Detailed description
This plan outlines a research project focusing on patients with prolonged ventilator use (PMV), an important manifestation of chronic critical illness (CCI) characterized by prolonged ventilator use after acute illness. This research team has sufficient experience in PMV clinical research and observed that even in the standardized process of weaning from the ventilator, the proportion of patients who successfully weaned from the ventilator was still low. Only 57.9% of the patients were successfully weaned from the ventilator, while the others were Transfer to a long-term care facility or face adverse outcomes. This research project aims to identify important respiratory physiology factors that increase the chances of PMV patients being weaned from ventilators and address a key unanswered question. PMV is often the result of CCI and involves complex clinical challenges such as organ dysfunction, dysregulated immune response, and recurrent infections. Patients' responses to disengagement training vary, often requiring individualized strategies. Conventional lung monitoring using electrical impedance imaging (EIT) can be used to quantify regional hyperinflation and collapse at each level. This method is based on pixel-level changes in respiratory system compliance and depends on whether the patient is fixed or Measured driving pressure, airway pressure (Paw), esophageal pressure (Pes) while accounting for assisted ventilation; EIT monitoring to quantify lung overinflation and collapse Use intrathoracic driving pressure (ΔPLdyn) changes to assess lung compliance at the pixel level change. We will use currently available methods, combining EIT and Pes monitoring, to measure ΔPLdyn in PMV patients. It has been shown in the literature that using ΔPLdyn rather than dynamic airway driving pressure to quantify regional lung overinflation and collapse, that is, compliance changes, is physiologically reasonable and clinically feasible. This method may represent a more accurate assessment of regional lung mechanics associated with the lowest inspiratory effort in the assisted ventilation setting. We hope to understand the changes in regional lung ventilation and compliance of PMV patients during the respirator weaning test through a series of clinical respiratory physiology research processes, in order to find ways to improve the patient's chances of weaning off.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 16 Weeks
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This project hopes to conduct research on patients on prolonged ventilator use (PMV). This group is an important manifestation of chronic severe illness and prolonged use of respirators after acute illness.
Key inclusion criteria (3 listed)
- Post-tracheostomy patients who are transferred to the subacute respiratory care ward of National Taiwan University Hospital must use respirators for at least 14 days;
- Be at least 20 years old;
- The oxygen concentration required when using the respirator does not exceed 50%
Key exclusion criteria (5 listed)
- The vital signs are unstable or require continuous use of vasopressors;
- Pregnancy;
- Chronic obstructive pulmonary disease or asthma;
- Those who have contraindications to the placement of esophageal pressure balloons, such as abnormal blood coagulation, esophageal varices, and those who have undergone esophageal or gastric surgery in the past six months;
- Those who have contraindications to the use of electrical impedance tomography, such as heart rhythm regulators.
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
SIMV+PSV（Synchronized intermittent mandatory ventilation + pressure support ventilation)
Time frame: ．up to 16 weeks
Timing points for measurement in respiratory physiology assessment include: 1) once when the ventilator is reduced to the lowest supported SIMV+PV mode, and once in the first and fourth hours of the four-hour weaning test period (collar mask), for a total of three times. The measurement tools were the EIT measuring instrument (PulmoVista 500, Dräger Medical, Lübeck, Germany) and the IC measuring instrument Engström Carestation (GE Healthcare, Madison, WI, USA) available in the Department of Respiratory Therapy of our hospital. The methods for measuring EIT 62,64 and IC 57 were as described in the literature30. Tubes will also be installed and connected to the instruments provided by the respiratory therapy department. The esophageal pressure measurement tube is an esophageal balloon similar to a nasogastric tube. The esophageal balloon used in this study has two functions of pressure measurement and nasogastric tube (Nutrivent®), which can be placed for 30 days and has the function of
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 4 Jun 2025.
- Individual participant dataSharing planned: Yes. This project focuses on analyzing the correlation between transpulmonary driving pressure, lung ventilation heterogeneity and regional lung compliance in patients with prolonged mechanical ventilation (PMV), so as to understand the clinical causes of failure of the final spontaneous breathing test and inability to breathe. Physiological aspects of breathing in patients successfully discharged from hospital off ventilators.
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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.
Jih-Shuin Jerng, MD, PhD, Principal Investigator contact
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 Weaning Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
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 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 4 Jun 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 Taiwan. 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 Jih-Shuin Jerng, MD, PhD, Principal Investigator (+886-2-23123456 ext. Ext. 263532, jsjerng@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIMV+PSV（Synchronized intermittent mandatory ventilation + pressure support ventilation) (time frame: ．up to 16 weeks). 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 4 Jun 2025.