Acute Respiratory Distress SyndromeNCT06586736
Physiological Studies in the Prone Position in Patients With ARDS
An observational study of Acute Respiratory Distress Syndrome and Mechanical Ventilation, run by West China Hospital at 1 site in China.
Trial summary
The purpose of this study is to observe the changes of physiological indicators such as ventilation and oxygenation in the prone position of ARDS patients, to observe the change trend of each patient's indicators, and to observe whether different trends of indicators predict different prognosis of patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Mechanical Ventilation, Prone Positioning
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to Jun 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We conducted a prospective cohort study in a intensive care unit in West China Hospital, Sichuan University, China. Adult patients (age≥18years) who were diagnosed with moderate to severe ARDS according to the Berlin definition, received mechanical ventilation and prone positioning were included.
Who may be able to join
- Intubated patients
- Undergoing mechanical ventilation
- Moderate to severe ARDS
- Undergoing prone positioning
- Age≥18 years old
Who cannot join
- Pregnant
- Cardiac structural shunt
- Extracorporeal membrane oxygenation performed
- Undergo extracorporeal CO2 removal
- Pulmonary embolism
- Other situation that may affect the accuracy of PetCO2 monitoring
- Prone positioning session less than 10 hours
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Critical care medicine of West China Hospital
Chengdu, Sichuan, 610041
Y F zhou, MM, 8613880012276, zyfmg@163.com
Y Y Yang, MM, 8615208341257, 942430456@qq.com
About this study
Official title: The Respiratory Physiologic Efficacy of Prone Position and Its Association With Outcomes in ARDS: A Prospective Observational Cohort Study
The purpose of this study is to observe the changes of physiological indicators such as ventilation and oxygenation in the prone position of ARDS patients, to observe the change trend of each patient's indicators, and to observe whether different trends of indicators predict different prognosis of patients.
Read the detailed description
PP has been shown to effectively improve the prognosis of patients with severe ARDS, but not all patients with ARDS can benefit from PP, and the implementation of the PP has a certain clinical risks and side effects, we lack a convenient predictors to guide doctors to determine whether patients should implement the PP. Clinical usually observe the P/F improved as whether PP treatment effective reference, but there are literature points out that the rising P/F after PP can not predict the better prognosis. one of the mechanisms for ARDS patients benefit from PP is proved to be improve V/Q, the change of the V/Q may determine whether the PP treatment effectively is an important indicator. PaO2:FiO2 ratio was usually used to evaluate the effect of PP, but some studies did not support this conclusion. PP has been shown to change ventilation-perfusion ratio, dead space may be better physiological indicators, simplify dead space ratio and Ventilatory ratio can be easily accessed at bedside and is associated with mortality of patients with ARDS. The purpose of this study is to observe the predictive value of P/F, VD-etCO2/VT, and VR on the treatment effect of ARDS undergoing PP.
- Keywords
- Prone positioning, ARDS, Dead space ratio, Ventilatory ratio, Ventilation/perfusion
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
28 days without mechanical ventilation
Days without mechanical ventilation support within 28 days after enrollment
Measured: From the date of enrollment to 28 days
Secondary outcomes (4)
ICU mortality and in-hospital mortality
Prognostic measures will be recorded until discharge, such as ICU mortality and in-hospital mortality
Measured: From the date of enrollment until the date of discharge, assessed up to 1 year
Length of lCU stay and length of hospital stay
Prognostic measures will be recorded until discharge, such as length of lICU stay and length of hospital stay in days.
Measured: From the date of enrollment until the date of discharge, assessed up to 1 year.
Respiratory physiological parameters.
Respiratory physiological parameters are collected at each time point (before prone positioning , every 4 hours after prone positioning, and 4 hours after turn back to supine position), such as PaO2/FiO2。
Measured: From enrollment to Day 7.
Indicators related to dead space
Indicators related to dead space are collected at each time point (before prone positioning , every 4 hours after prone positioning, and 4 hours after turn back to supine position), such as VR and dead space ratio, which were calculated by predicted body weight, partial pressure of carbon dioxide and end-tidal carbon dioxide
Measured: From enrollment to Day 7.
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 Sep 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (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 West China 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
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Yongfang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586736
- Sponsor's protocol ID
- Prone position
- Status last verified
- Feb 2025
- First submitted
- 30 Aug 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any data collected during this study can be acquired from the correspondingauthor upon a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Respiratory Physiologic Efficacy of Prone Position and Its Association With Outcomes in ARDS: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06586736
- Acronym / sponsor ID
- Prone position
- Keywords
- Prone positioning, ARDS, Dead space ratio, Ventilatory ratio, Ventilation/perfusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 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.
The purpose of this study is to observe the changes of physiological indicators such as ventilation and oxygenation in the prone position of ARDS patients, to observe the change trend of each patient's indicators, and to observe whether different trends of indicators predict different prognosis of patients.
Detailed description
PP has been shown to effectively improve the prognosis of patients with severe ARDS, but not all patients with ARDS can benefit from PP, and the implementation of the PP has a certain clinical risks and side effects, we lack a convenient predictors to guide doctors to determine whether patients should implement the PP. Clinical usually observe the P/F improved as whether PP treatment effective reference, but there are literature points out that the rising P/F after PP can not predict the better prognosis. one of the mechanisms for ARDS patients benefit from PP is proved to be improve V/Q, the change of the V/Q may determine whether the PP treatment effectively is an important indicator. PaO2:FiO2 ratio was usually used to evaluate the effect of PP, but some studies did not support this conclusion. PP has been shown to change ventilation-perfusion ratio, dead space may be better physiological indicators, simplify dead space ratio and Ventilatory ratio can be easily accessed at bedside and is associated with mortality of patients with ARDS. The purpose of this study is to observe the predictive value of P/F, VD-etCO2/VT, and VR on the treatment effect of ARDS undergoing PP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We conducted a prospective cohort study in a intensive care unit in West China Hospital, Sichuan University, China. Adult patients (age≥18years) who were diagnosed with moderate to severe ARDS according to the Berlin definition, received mechanical ventilation and prone positioning were included.
Key inclusion criteria (5 listed)
- Intubated patients
- Undergoing mechanical ventilation
- Moderate to severe ARDS
- Undergoing prone positioning
- Age≥18 years old
Key exclusion criteria (7 listed)
- Pregnant
- Cardiac structural shunt
- Extracorporeal membrane oxygenation performed
- Undergo extracorporeal CO2 removal
- Pulmonary embolism
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
28 days without mechanical ventilation
Time frame: From the date of enrollment to 28 days
Days without mechanical ventilation support within 28 days after enrollment
4 secondary outcomes
ICU mortality and in-hospital mortality
Time frame: From the date of enrollment until the date of discharge, assessed up to 1 year
Length of lCU stay and length of hospital stay
Time frame: From the date of enrollment until the date of discharge, assessed up to 1 year.
Respiratory physiological parameters.
Time frame: From enrollment to Day 7.
Indicators related to dead space
Time frame: From enrollment to Day 7.
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 3 Mar 2025.
- Individual participant dataSharing planned: Yes. Any data collected during this study can be acquired from the correspondingauthor upon a reasonable request.
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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 Acute Respiratory Distress Syndrome and Mechanical Ventilation, run by West China 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 5 inclusion and 7 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 3 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 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?
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?
28 days without mechanical ventilation (time frame: From the date of enrollment to 28 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 3 Mar 2025.