ARDS (Acute Respiratory Distress Syndrome)NCT06734988
EXTEND ARDS-J Esophageal Pressure Study
An observational study of ARDS (Acute Respiratory Distress Syndrome), run by Sapporo Medical University at 1 site in Japan.
Trial summary
Background: Acute respiratory distress syndrome (ARDS) patients require careful assessment before extubation to prevent failure, which is associated with poor outcomes. While current guidelines recommend weaning protocols, these are based on general respiratory failure studies rather than ARDS-specific data. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- 4 Dec 2024to 28 Feb 2027
- How long will I take part?
- 3 Months
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult mechanically ventilated patients (≥ 16 years old) expected to receive invasive mechanical ventilator for more than 48 hours
Who may be able to join
- Adult mechanically ventilated patients (≥ 16 years old) with esophageal pressure monitoring, expected to receive invasive mechanical ventilator for more than 48 hours
- Patients who meet the diagnosis of ARDS at the start of invasive mechanical ventilation based on a new global definition of ARDS.
Who cannot join
- Patients who already had tracheostomy at the start of invasive mechanical ventilation
- Patients who were transferred to participating hospital more than 2 days after the start of invasive mechanical ventilation
- Patients with terminal conditions at the start of invasive mechanical ventilation
- Patients who have expressed their refusal to have their clinical data used in research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Sapporo Medical University
Sapporo, Hokkaido, 060-8556
Ryuichi Nakayama, MD, PhD, +81-11-611-2111, ryuichi.nakayama@sapmed.ac.jp
About this study
Official title: Japanese Esophageal Pressure Sub-study of EXTubation Evaluation and Respiratory Dynamics in Acute Respiratory Distress Syndrome (EXTEND ARDS-J EP Study)
Background: Acute respiratory distress syndrome (ARDS) patients require careful assessment before extubation to prevent failure, which is associated with poor outcomes. While current guidelines recommend weaning protocols, these are based on general respiratory failure studies rather than ARDS-specific data. Esophageal pressure (Pes) measurement provides direct assessment of inspiratory effort but is rarely utilized clinically.
Objectives: This Japanese sub-study of EXTEND ARDS aims to evaluate whether:
Read more
- ΔPes measurements during spontaneous breathing trials (SBT) can predict SBT failure
- ΔPes measurements post-extubation can predict 48-hour extubation failure
Methods: This prospective observational study will be conducted in Japanese ICUs. Esophageal pressure will be measured using standardized Nutrivent balloons (4mL volume) with Hamilton ventilators. Balloon placement in the lower third of the esophagus will be confirmed by cardiac artifacts and chest X-ray. ΔPes will be calculated as the difference between end-expiratory and peak inspiratory esophageal pressure, excluding esophageal contractions.
Significance: This study addresses a knowledge gap regarding the utility of esophageal pressure monitoring in ARDS patients during mechanical ventilation weaning. Findings may help optimize extubation timing and improve patient outcomes through objective physiological measurements.
Read the detailed description
- Background Acute respiratory distress syndrome (ARDS) remains a life-threatening condition with high mortality among mechanically ventilated patients. While current guidelines recommend weaning protocols for extubation, these are primarily based on studies of general acute respiratory failure rather than ARDS-specific populations. Inspiratory effort assessment during liberation from mechanical ventilation traditionally relies on respiratory rate monitoring during spontaneous breathing trials (SBT). However, esophageal pressure (Pes) measurement, which provides direct measurement of inspiratory effort, is rarely utilized in clinical practice. This is particularly relevant in ARDS patients, where excessive inspiratory effort can induce pendelluft phenomenon, potentially causing dorsal lung injury in the supine position. Recent studies have shown that diaphragmatic contraction, maximum inspiratory pressure, ΔPes, and trans-diaphragmatic pressure can predict successful weaning in prolonged mechanical ventilation patients. However, there remains a significant knowledge gap regarding the utility of esophageal pressure measurements in predicting SBT and extubation success specifically in ARDS patients.
- Study Significance This Japanese sub-study of the EXTEND ARDS trial will investigate whether ΔPes measurements during SBT and post-extubation can predict extubation outcomes in ARDS patients. By incorporating esophageal pressure monitoring, this study aims to provide objective physiological data to improve the prediction of extubation success and optimize the timing of liberation from mechanical ventilation.
- Study Design and Methods This is a prospective observational sub-study conducted in Japanese ICUs. Esophageal pressure will be measured using Nutrivent balloons with Hamilton C6 or G5 ventilators. The balloon placement will be confirmed by cardiac artifacts and chest X-ray, positioned in the lower third of the esophagus. Balloon volume will be standardized at 4mL, following manufacturer recommendations and GLOBAL WEAN study protocols.
- Primary Objectives
To evaluate whether:
- ΔPes measurements during SBT can predict SBT failure
- ΔPes measurements post-extubation can predict extubation failure within 48 hours
- Keywords
- Esophageal pressure, SBT
- Medical subject headings
- Acute Lung Injury
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 |
|---|---|---|
| Mechanically ventilated adult ARDS patients | Adult mechanically ventilated patients (≥ 16 years old) with esophageal pressure monitoring, expected to receive invasive mechanical ventilator for more than 48 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintubation within 48 hours after extubation
Occurrence of reintubation events within 48 hours after planned extubation
Measured: 48 hours after extubation
Secondary outcomes (1)
SBT Failure
Occurrence of SBT failure defined as inability to complete the spontaneous breathing trial
Measured: Up to 120 minutes from the start of spontaneous breathing trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start4 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sapporo Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734988
- Sponsor's protocol ID
- EXTEND_ARDS_J_EP_Study
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Japanese Esophageal Pressure Sub-study of EXTubation Evaluation and Respiratory Dynamics in Acute Respiratory Distress Syndrome (EXTEND ARDS-J EP Study)
- ClinicalTrials.gov ID
- NCT06734988
- Acronym / sponsor ID
- EXTEND_ARDS_J_EP_Study
- Keywords
- Esophageal pressure, SBT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sapporo Medical UniversityUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 16 Dec 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.
Background: Acute respiratory distress syndrome (ARDS) patients require careful assessment before extubation to prevent failure, which is associated with poor outcomes. While current guidelines recommend weaning protocols, these are based on general respiratory failure studies rather than ARDS-specific data. Esophageal pressure (Pes) measurement provides direct assessment of inspiratory effort but is rarely utilized clinically.
Objectives: This Japanese sub-study of EXTEND ARDS aims to evaluate whether:
- ΔPes measurements during spontaneous breathing trials (SBT) can predict SBT failure
- ΔPes measurements post-extubation can predict 48-hour extubation failure
Methods: This prospective observational study will be conducted in Japanese ICUs. Esophageal pressure will be measured using standardized Nutrivent balloons (4mL volume) with Hamilton ventilators. Balloon placement in the lower third of the esophagus will be confirmed by cardiac artifacts and chest X-ray. ΔPes will be calculated as the difference between end-expiratory and peak inspiratory esophageal pressure, excluding esophageal contractions.
Significance: This study addresses a knowledge gap regarding the utility of esophageal pressure monitoring in ARDS patients during mechanical ventilation weaning. Findings may help optimize extubation timing and improve patient outcomes through objective physiological measurements.
Detailed description
- Background Acute respiratory distress syndrome (ARDS) remains a life-threatening condition with high mortality among mechanically ventilated patients. While current guidelines recommend weaning protocols for extubation, these are primarily based on studies of general acute respiratory failure rather than ARDS-specific populations. Inspiratory effort assessment during liberation from mechanical ventilation traditionally relies on respiratory rate monitoring during spontaneous breathing trials (SBT). However, esophageal pressure (Pes) measurement, which provides direct measurement of inspiratory effort, is rarely utilized in clinical practice. This is particularly relevant in ARDS patients, where excessive inspiratory effort can induce pendelluft phenomenon, potentially causing dorsal lung injury in the supine position. Recent studies have shown that diaphragmatic contraction, maximum inspiratory pressure, ΔPes, and trans-diaphragmatic pressure can predict successful weaning in prolonged mechanical ventilation patients. However, there remains a significant knowledge gap regarding the utility of esophageal pressure measurements in predicting SBT and extubation success specifically in ARDS patients.
- Study Significance This Japanese sub-study of the EXTEND ARDS trial will investigate whether ΔPes measurements during SBT and post-extubation can predict extubation outcomes in ARDS patients. By incorporating esophageal pressure monitoring, this study aims to provide objective physiological data to improve the prediction of extubation success and optimize the timing of liberation from mechanical ventilation.
- Study Design and Methods This is a prospective observational sub-study conducted in Japanese ICUs. Esophageal pressure will be measured using Nutrivent balloons with Hamilton C6 or G5 ventilators. The balloon placement will be confirmed by cardiac artifacts and chest X-ray, positioned in the lower third of the esophagus. Balloon volume will be standardized at 4mL, following manufacturer recommendations and GLOBAL WEAN study protocols.
- Primary Objectives
To evaluate whether:
- ΔPes measurements during SBT can predict SBT failure
- ΔPes measurements post-extubation can predict extubation failure within 48 hours
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated adult ARDS patients | – | –Adult mechanically ventilated patients (≥ 16 years old) with esophageal pressure monitoring, expected to receive invasive mechanical ventilator for more than 48 hours |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult mechanically ventilated patients (≥ 16 years old) expected to receive invasive mechanical ventilator for more than 48 hours
Key inclusion criteria (2 listed)
- Adult mechanically ventilated patients (≥ 16 years old) with esophageal pressure monitoring, expected to receive invasive mechanical ventilator for more than 48 hours
- Patients who meet the diagnosis of ARDS at the start of invasive mechanical ventilation based on a new global definition of ARDS.
Key exclusion criteria (4 listed)
- Patients who already had tracheostomy at the start of invasive mechanical ventilation
- Patients who were transferred to participating hospital more than 2 days after the start of invasive mechanical ventilation
- Patients with terminal conditions at the start of invasive mechanical ventilation
- Patients who have expressed their refusal to have their clinical data used in research
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
Reintubation within 48 hours after extubation
Time frame: 48 hours after extubation
Occurrence of reintubation events within 48 hours after planned extubation
1 secondary outcome
SBT Failure
Time frame: Up to 120 minutes from the start of spontaneous breathing trial
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 16 Dec 2024.
- Individual participant dataSharing planned: Yes. Study protocol
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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?
An observational study of ARDS (Acute Respiratory Distress Syndrome), run by Sapporo Medical University at 1 site in Japan.
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 4 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 16 Dec 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 Japan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reintubation within 48 hours after extubation (time frame: 48 hours after extubation). 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 16 Dec 2024.