Acute Respiratory Distress SyndromeNCT06827184
By Assessing the Continuous Respiratory Physiological Changes Through Prone Position, Determine the Optimal Duration for Prone Position
An observational study of Acute Respiratory Distress Syndrome and Prone Position, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The prone position leads to a more homogeneous distribution of ventilation by inflation of collapsed alveoli and reduction in alveolar hyperinflation. By employing EIT, the study can obtain a thorough comprehension of the ongoing alterations in regional ventilation before and after adopting the prone position. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Prone Position, Electrical Impedance Tomography
- What is being tested?
- Electrical Impedance Tomography
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Sep 2024to 31 Dec 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study focuses on patients with severe acute respiratory distress syndrome undergoing prone position therapy.
Who may be able to join
- Acute respiratory distress syndrome
- Age > 18
- Serial arterial blood gas data：PaO2/FiO2 <150. The mechanical ventilator setting：FiO2>0.6, PEEP>5 cmH2O
Who cannot join
- Implantable electronic devices (e.g., pacemakers)
- Body mass index > 30
- Major thoracic and abdominal surgery
- Patients with unstable spine and pelvis conditions
- Pregnant women in the second and third trimesters
- Patients with head trauma, elevated intracranial pressure, or elevated intraocular pressure
- Hemodynamically unstable patients unsuitable for prone ventilation therapy
- Patients with active seizures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Ting-Yu Liao, MD, +886 2 23123456, tingyuliao@ntuh.gov.tw
About this study
The prone position leads to a more homogeneous distribution of ventilation by inflation of collapsed alveoli and reduction in alveolar hyperinflation. By employing EIT, the study can obtain a thorough comprehension of the ongoing alterations in regional ventilation before and after adopting the prone position. It is also anticipated that there is an impact on inflammation biomarkers before and after the prone position. This assessment aids in determining the ideal duration for prone position therapy, encompassing the necessary hours and days in the prone position.
Read the detailed description
The prone position leads to a more homogeneous distribution of ventilation by inflation of collapsed alveoli and reduction in alveolar hyperinflation. By employing EIT, the study can obtain a thorough comprehension of the ongoing alterations in regional ventilation before and after adopting the prone position. It is also anticipated that there is an impact on inflammation biomarkers before and after the prone position. This assessment aids in determining the ideal duration for prone position therapy, encompassing the necessary hours and days in the prone position.
Therefore, the investigators propose a project with the aim of collecting relevant clinical, laboratory, imaging, and respiratory physiology data from consenting patients with ARDS within the study period. The objective is to analyze changes in biomarkers following prone position.
- Being tested
- Electrical Impedance Tomography
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedance TomographyDevice
It utilizes electrical impedance tomography to analyze a series of physiological changes in the lungs following treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Prone response
Responder is defined as an increase in PaO2 by 20 mmHg or an increase in PaO2/FiO2 by 20% one hour after receiving prone position therapy
Measured: During the prone position(5 days)
Secondary outcomes (1)
28-day mortality
The mortality status on the 28th day
Measured: On the 28th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start20 Sep 2024
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
- Investigators
- Ting-Yu Liao, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827184
- Sponsor's protocol ID
- 202310137DIND
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 19 Feb 2025
- 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- By Assessing the Continuous Respiratory Physiological Changes Through Prone Position, Determine the Optimal Duration for Prone Position
- ClinicalTrials.gov ID
- NCT06827184
- Acronym / sponsor ID
- 202310137DIND
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 Feb 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.
The prone position leads to a more homogeneous distribution of ventilation by inflation of collapsed alveoli and reduction in alveolar hyperinflation. By employing EIT, the study can obtain a thorough comprehension of the ongoing alterations in regional ventilation before and after adopting the prone position. It is also anticipated that there is an impact on inflammation biomarkers before and after the prone position. This assessment aids in determining the ideal duration for prone position therapy, encompassing the necessary hours and days in the prone position.
Detailed description
The prone position leads to a more homogeneous distribution of ventilation by inflation of collapsed alveoli and reduction in alveolar hyperinflation. By employing EIT, the study can obtain a thorough comprehension of the ongoing alterations in regional ventilation before and after adopting the prone position. It is also anticipated that there is an impact on inflammation biomarkers before and after the prone position. This assessment aids in determining the ideal duration for prone position therapy, encompassing the necessary hours and days in the prone position.
Therefore, the investigators propose a project with the aim of collecting relevant clinical, laboratory, imaging, and respiratory physiology data from consenting patients with ARDS within the study period. The objective is to analyze changes in biomarkers following prone position.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study focuses on patients with severe acute respiratory distress syndrome undergoing prone position therapy.
Key inclusion criteria (3 listed)
- Acute respiratory distress syndrome
- Age > 18
- Serial arterial blood gas data：PaO2/FiO2 <150. The mechanical ventilator setting：FiO2>0.6, PEEP>5 cmH2O
Key exclusion criteria (8 listed)
- Implantable electronic devices (e.g., pacemakers)
- Body mass index > 30
- Major thoracic and abdominal surgery
- Patients with unstable spine and pelvis conditions
- Pregnant women in the second and third trimesters
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 |
|---|---|---|
| Electrical Impedance TomographyIt utilizes electrical impedance tomography to analyze a series of physiological changes in the lungs following treatment | Device | – |
Primary outcome
Prone response
Time frame: During the prone position(5 days)
Responder is defined as an increase in PaO2 by 20 mmHg or an increase in PaO2/FiO2 by 20% one hour after receiving prone position therapy
1 secondary outcome
28-day mortality
Time frame: On the 28th day
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 19 Feb 2025.
- 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.
Ting-Yu Liao, MD principal investigator
National Taiwan University Hospital
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 Distress Syndrome and Prone Position, 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 8 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 19 Feb 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 Ting-Yu Liao, MD (+886 2 23123456, tingyuliao@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prone response (time frame: During the prone position(5 days)). 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 19 Feb 2025.