ARDS (Acute Respiratory Distress Syndrome)EXTEND ARDSNCT06598709
International Survey for EXTubation Evaluation and Respiratory Dynamics in Acute Respiratory Distress Syndrome
An observational study of ARDS (Acute Respiratory Distress Syndrome), run by Hiroshima University at 1 site in Japan.
Trial summary
EXTEND ARDS study is an international survey for ventilator weaning and extubation among ARDS patients. This study will be conducted on behalf of the Japanese ARDS Clinical Practice Guideline 2024 Committee as well as endorsement of the Japanese Society of Intensive Care Medicine, the Japanese Respiratory Society, and… 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
- 1,000 participants
- Where
- 1 siteJapan
- Study dates
- 1 Nov 2024to 31 Dec 2025
- 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) 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.
About this study
EXTEND ARDS study is an international survey for ventilator weaning and extubation among ARDS patients. This study will be conducted on behalf of the Japanese ARDS Clinical Practice Guideline 2024 Committee as well as endorsement of the Japanese Society of Intensive Care Medicine, the Japanese Respiratory Society, and the Japanese Society of Respiratory Care Medicine. This survey aims to prospectively collect the clinical data of mechanically ventilated ARDS patients related with ventilator weaning and extubation internationally as well as the outcome of ARDS patients with extubation failure. This study also aims to identify predictive factors strongly associated with extubation failure. The contents of mechanical ventilation settings, respiratory conditions, and blood examination data will be collected.
Read the detailed description
1.1. Background
Acute respiratory distress syndrome (ARDS) is a life-threatening condition characterized by widespread inflammatory lung injury, and is encountered in an estimated 23% of mechanically ventilated patients (1). Recent studies reported that the mortality of mechanically ventilated patients with ARDS was still as high as approximately 40% (1), which implies that better management strategies for them are needed to improve the outcomes.
In the management for the mechanical ventilated patients with ARDS, the timing and judgement for extubation is clinically important, because extubation failure can be associated with worse outcome (2). The most recent ARDS guidelines recommend a weaning protocol for extubation and introduced several predictive clinical factors for extubation failure, but they are mainly based on the studies for patients with acute respiratory failure (3), and there is no study focusing on the patients with ARDS. Considering that the best method to extubate successfully has not been determined, the clinical management at the timing of extubation can be varied by each institution or each country, and the investigators thought that international survey focusing on the management for extubation of ARDS patients would be needed.
1.2. Significance of the study
Our international survey can identify the management associated with better outcome as well as clinical factors to predict extubation failure at the timing of extubation attempt. This study will contribute to the development of better management for extubation and thereby improve the outcomes of patients with ARDS.
This study has the potential to increase the generalizability of the results which will be obtained from all regions of the world, including Asia, Europe, North and South America, Oceania, and Africa. Therefore, the results will potentially contribute to improving patient outcomes in all regions of the world. Furthermore, the results obtained will provide a detailed picture of the current ICU management given to mechanical ventilated patients with ARDS in the ICU.
1.3．Study Design
This study is international multicenter prospective survey.
- Aim of the study and evaluation items 2.1. Study Hypothesis
- Mortality of ARDS patients with extubation failure is higher than those without failure.
- Management and timing for ventilator weaning and extubation failure is different by each institution, each country, or each continent, some of which is associated with their outcome.
- Some clinical factors for predicting extubation failure is identified.
2.2. Aim of the study Aim 1: Describing epidemiology, management, timing, and outcome for ventilator weaning and extubation of ARDS patients in the world Aim 2: Comparing the protocol for weaning and extubation between the ARDS patients who had successful extubation and those who did not Aim 3: Comparing the change of respiratory mechanics in the SBT and post-extubation between the ARDS patients who had successful extubation and those who did not Aim 4: Identifying clinical factor available during SBT and in the early times after extubation for predicting extubation failure
- Keywords
- extubation, ARDS, SBT, Spontaneous Breathing Trial, Acute Respiratory Distress Syndrome
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome
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) 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.
90 days in-hospital mortality
90 days in-hospital mortality
Measured: From intubation to 90 days after intubation
occurrence of re-intubation event
occurrence of re-intubation event
Measured: From extubation until the hospital discharge, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Nov 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (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
- 1,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitsuaki Nishikimi, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598709
- Sponsor's protocol ID
- EXTEND_ARDS_study
- Other IDs
- EXTEND_ARDS_study
- Acronym
- EXTEND ARDS
- Status last verified
- Mar 2025
- First submitted
- 11 Sep 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Survey for EXTubation Evaluation and Respiratory Dynamics in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT06598709
- Acronym / sponsor ID
- EXTEND ARDS / EXTEND_ARDS_study
- Keywords
- extubation, ARDS, SBT, Spontaneous Breathing Trial, Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 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.
EXTEND ARDS study is an international survey for ventilator weaning and extubation among ARDS patients. This study will be conducted on behalf of the Japanese ARDS Clinical Practice Guideline 2024 Committee as well as endorsement of the Japanese Society of Intensive Care Medicine, the Japanese Respiratory Society, and the Japanese Society of Respiratory Care Medicine. This survey aims to prospectively collect the clinical data of mechanically ventilated ARDS patients related with ventilator weaning and extubation internationally as well as the outcome of ARDS patients with extubation failure. This study also aims to identify predictive factors strongly associated with extubation failure. The contents of mechanical ventilation settings, respiratory conditions, and blood examination data will be collected.
Detailed description
1.1. Background
Acute respiratory distress syndrome (ARDS) is a life-threatening condition characterized by widespread inflammatory lung injury, and is encountered in an estimated 23% of mechanically ventilated patients (1). Recent studies reported that the mortality of mechanically ventilated patients with ARDS was still as high as approximately 40% (1), which implies that better management strategies for them are needed to improve the outcomes.
In the management for the mechanical ventilated patients with ARDS, the timing and judgement for extubation is clinically important, because extubation failure can be associated with worse outcome (2). The most recent ARDS guidelines recommend a weaning protocol for extubation and introduced several predictive clinical factors for extubation failure, but they are mainly based on the studies for patients with acute respiratory failure (3), and there is no study focusing on the patients with ARDS. Considering that the best method to extubate successfully has not been determined, the clinical management at the timing of extubation can be varied by each institution or each country, and the investigators thought that international survey focusing on the management for extubation of ARDS patients would be needed.
1.2. Significance of the study
Our international survey can identify the management associated with better outcome as well as clinical factors to predict extubation failure at the timing of extubation attempt. This study will contribute to the development of better management for extubation and thereby improve the outcomes of patients with ARDS.
This study has the potential to increase the generalizability of the results which will be obtained from all regions of the world, including Asia, Europe, North and South America, Oceania, and Africa. Therefore, the results will potentially contribute to improving patient outcomes in all regions of the world. Furthermore, the results obtained will provide a detailed picture of the current ICU management given to mechanical ventilated patients with ARDS in the ICU.
1.3．Study Design
This study is international multicenter prospective survey.
- Aim of the study and evaluation items 2.1. Study Hypothesis
- Mortality of ARDS patients with extubation failure is higher than those without failure.
- Management and timing for ventilator weaning and extubation failure is different by each institution, each country, or each continent, some of which is associated with their outcome.
- Some clinical factors for predicting extubation failure is identified.
2.2. Aim of the study Aim 1: Describing epidemiology, management, timing, and outcome for ventilator weaning and extubation of ARDS patients in the world Aim 2: Comparing the protocol for weaning and extubation between the ARDS patients who had successful extubation and those who did not Aim 3: Comparing the change of respiratory mechanics in the SBT and post-extubation between the ARDS patients who had successful extubation and those who did not Aim 4: Identifying clinical factor available during SBT and in the early times after extubation for predicting extubation failure
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) 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) 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
90 days in-hospital mortality
Time frame: From intubation to 90 days after intubation
90 days in-hospital mortality
occurrence of re-intubation event
Time frame: From extubation until the hospital discharge, assessed up to 24 months
occurrence of re-intubation event
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 20 Mar 2025.
- 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.
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 ARDS (Acute Respiratory Distress Syndrome), run by Hiroshima 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: enrolling by invitation, as of the sponsor's last update on 20 Mar 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 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?
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?
90 days in-hospital mortality (time frame: From intubation to 90 days after intubation). The study lists 2 primary outcomes in all. 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 20 Mar 2025.