Acute Respiratory Distress SyndromeNCT06215209
Effect of PP in Patients With Ultra-low VT
An observational study of Acute Respiratory Distress Syndrome and Prone Position, run by Southeast University, China at 1 site in China.
Trial summary
Acute respiratory distress syndrome (ARDS) is a heterogeneous syndrome with similar clinicopathological feathers caused by different etiologies. Respiratory supportive strategies is the main ARDS management, and the guidelines recommend low tidal volume to improve clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Prone Position, Tidal Volume
- What is being tested?
- position
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult patients with ARDS admitted to the Department of Critical Care Medicine, Zhongda Hospital, Southeast University and receiving VV-ECMO treatment
Who may be able to join
- Adult patients were enrolled if they were undergoing invasive mechanical ventilation and were supported by VV-ECMO for less than 48 hours
Who cannot join
- younger than 18 years old
- contraindications for prone position ventilation
- past chronic respiratory diseases (long-term family oxygen therapy for chronic
- respiratory diseases such as pulmonary fibrosis or COPD)
- New York Heart Association class above II
- contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing) or prone position (as decided by the attending physician)
- severe hemodynamic instability
- gave written or witnessed verbal informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, 210000
ling liu, phD, 86-25-83272201, liulingdoctor@126.com
About this study
Official title: Physiological Effect of Prone Position in Patients With Ultra-low Tidal Volume Ventilation
Acute respiratory distress syndrome (ARDS) is a heterogeneous syndrome with similar clinicopathological feathers caused by different etiologies. Respiratory supportive strategies is the main ARDS management, and the guidelines recommend low tidal volume to improve clinical outcomes. To be note, overdistension can still occur even if using a tidal volume as low as 6 ml/kg, given the heterogeneous nature of the syndrome. Therefore, adjusting tidal volume level to less than 6ml/kg may reduce ventilator-induced lung injury (VILI) and thus improve outcomes, especially in patients with severe lung injury. Prone position is also an important management in severe ARDS. Prone position can improve ventilation-perfusion (V/Q) matching and reduce the risk of VILI by recruiting dorsal collapsed alveoli. Meanwhile, prone position has also been shown to improve hemodynamics. Recent studies have showed that prone position did not reduce duration of venovenous extracorporeal membrane oxygenation (VV-ECMO) and 90-day mortality in patients with ARDS who receive VV-ECMO with ultra-low tidal volume ventilation. Therefore, the effect of PP on ventilation and lung blood flow in ARDS patients treated with VV-ECMO wiht ultra-low tidal volume ventilation remains unclear.
- Being tested
- position
- 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.
positionOther
patients will be in supine position and prone position
| Study group | Role | What they receive |
|---|---|---|
| ultra-low tidal volume group | ARDS patients with ultra-low tidal volume ventilation Receives: Other: position |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilation-perfusion mathching
ventilation-perfusion matching will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) in supine position and prone position
Measured: up to 24 hours
Secondary outcomes (8)
The percentage of shunt
The percentage of shunt will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) in supine position and prone position
Measured: up to 24 hours
The percentage of dead space
The percentage of shunt will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) in supine position and prone position
Measured: up to 24 hours
The percentage of dorsal ventilation
The percentage of dorsal ventilation will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) in supine position and prone position
Measured: up to 24 hours
The percentage of dorsal perfusion
The percentage of dorsal ventilation will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) in supine position and prone position
Measured: up to 24 hours
Center of ventilation (CoV)
Center of ventilation will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) in supine position and prone position
Measured: up to 24 hours
Regional ventilation delay (RVD)
Regional ventilation delay will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) in supine position and prone position
Measured: up to 24 hours
Arterial blood gas analysis
Arterial blood gas analysis included pH, PaO2, PaCO2 and PaO2/FiO2 in supine position and prone position
Measured: up to 24 hours
Respiratory system compliance
Respiratory system compliance will be monitored in supine position and prone position.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start20 Feb 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Apr 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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- liu ling, phD, Study chair, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215209
- Sponsor's protocol ID
- Ultra-low VT and PP
- Status last verified
- Apr 2024
- First submitted
- 10 Jan 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effect of Prone Position in Patients With Ultra-low Tidal Volume Ventilation
- ClinicalTrials.gov ID
- NCT06215209
- Acronym / sponsor ID
- Ultra-low VT and PP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 22 Jan 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.
Acute respiratory distress syndrome (ARDS) is a heterogeneous syndrome with similar clinicopathological feathers caused by different etiologies. Respiratory supportive strategies is the main ARDS management, and the guidelines recommend low tidal volume to improve clinical outcomes. To be note, overdistension can still occur even if using a tidal volume as low as 6 ml/kg, given the heterogeneous nature of the syndrome. Therefore, adjusting tidal volume level to less than 6ml/kg may reduce ventilator-induced lung injury (VILI) and thus improve outcomes, especially in patients with severe lung injury. Prone position is also an important management in severe ARDS. Prone position can improve ventilation-perfusion (V/Q) matching and reduce the risk of VILI by recruiting dorsal collapsed alveoli. Meanwhile, prone position has also been shown to improve hemodynamics. Recent studies have showed that prone position did not reduce duration of venovenous extracorporeal membrane oxygenation (VV-ECMO) and 90-day mortality in patients with ARDS who receive VV-ECMO with ultra-low tidal volume ventilation. Therefore, the effect of PP on ventilation and lung blood flow in ARDS patients treated with VV-ECMO wiht ultra-low tidal volume ventilation remains unclear.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultra-low tidal volume group | – | Other: positionARDS patients with ultra-low tidal volume ventilation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with ARDS admitted to the Department of Critical Care Medicine, Zhongda Hospital, Southeast University and receiving VV-ECMO treatment
Key inclusion criteria (1 listed)
- Adult patients were enrolled if they were undergoing invasive mechanical ventilation and were supported by VV-ECMO for less than 48 hours
Key exclusion criteria (8 listed)
- younger than 18 years old
- contraindications for prone position ventilation
- past chronic respiratory diseases (long-term family oxygen therapy for chronic
- respiratory diseases such as pulmonary fibrosis or COPD)
- New York Heart Association class above II
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 |
|---|---|---|
| positionpatients will be in supine position and prone position | Other | ultra-low tidal volume group |
Primary outcome
ventilation-perfusion mathching
Time frame: up to 24 hours
ventilation-perfusion matching will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) in supine position and prone position
8 secondary outcomes
The percentage of shunt
Time frame: up to 24 hours
The percentage of dead space
Time frame: up to 24 hours
The percentage of dorsal ventilation
Time frame: up to 24 hours
The percentage of dorsal perfusion
Time frame: up to 24 hours
Center of ventilation (CoV)
Time frame: up to 24 hours
Regional ventilation delay (RVD)
Time frame: up to 24 hours
Arterial blood gas analysis
Time frame: up to 24 hours
Respiratory system compliance
Time frame: up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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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. This study is not recruiting at the moment.
liu ling, phD study chair
Zhongda 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 Southeast University, China 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 1 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: status not confirmed, as of the sponsor's last update on 30 Apr 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact liu ling, phD (025-83262550, liulingdoctor@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventilation-perfusion mathching (time frame: up to 24 hours). 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 30 Apr 2024.