ARDS (Acute Respiratory Distress Syndrome)NCT06748807
Physiological Effects of APRVplus and TCAV in ARDS
A study testing APRVplus and TCAV in people with ARDS (Acute Respiratory Distress Syndrome), run by West China Hospital at 1 site in China.
Trial summary
In previous studies, airway pressure release ventilation (APRV) has been proven to be an important respiratory support method for ARDS patients, and various APRV ventilation strategies have been proposed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- APRVplus and TCAV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2023to 15 Dec 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- intubated and mechanically ventilated patients
- meet the 2023 global new definition of ARDS
Who cannot join
- Pregnancy
- The expected duration of mechanical ventilation was less than 48 hours
- Intracranial hypertension (suspected or confirmed)
- Neuromuscular disorders that are known to prolong the need for mechanical ventilation
- Known or suspected chronic obstructive pulmonary disease(COPD)
- Terminal stage of disease
Show all 9Show fewer
- Pneumothorax (drained or not)at enrollment
- Treatment with extracorporeal support (ECMO) at enrollment
- There was a lack of commitment to life support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Effects of Early Pathophysiology-driven Airway Pressure Release Ventilation (APRVplus) and Time-Controlled Adaptive Ventilation (TCAV) in Acute Respiratory Distress Syndrome (ARDS): a Randomized Crossover Clinical Trial
In previous studies, airway pressure release ventilation (APRV) has been proven to be an important respiratory support method for ARDS patients, and various APRV ventilation strategies have been proposed. This study aims to compare the physiological effects of two types of APRV ventilation strategy, Early Pathophysiology-driven APRV (APRVplus) and Time-Controlled Adaptive Ventilation (TCAV), through randomized crossover trials, providing evidence for clinical application and further research on APRV.
- Being tested
- APRVplus, TCAV
- 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.
APRVplusProcedure or surgery
Early Pathophysiology-driven Airway Pressure Release Ventilation (APRVplus)
TCAVProcedure or surgery
Time-Controlled Adaptive Ventilation (TCAV)
| Study group | Role | What they receive |
|---|---|---|
| APRVplus | Experimental | An Early Pathophysiology-driven Airway Pressure Release Ventilation Receives: Procedure: APRVplus |
| TCAV | Other | Time Controlled Adaptive Ventilation (TCAV) Receives: Procedure: TCAV |
What is being measured
The primary outcome is the main question the study is designed to answer.
△PL（PLThigh - PLTlow)
Transpulmonary pressure swings (△PL) equal to PLThigh - PLTlow
Measured: during the mechanical ventilation procedure
Secondary outcomes (3)
EtCO2
end-tidal carbon dioxide
Measured: during the mechanical ventilation procedure
GI
global inhomogeneity
Measured: during the mechanical ventilation procedure
PaO2(mmHg)
the arterial partial pressure of oxygen
Measured: during the mechanical ventilation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start15 Dec 2023
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Yongfang, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748807
- Sponsor's protocol ID
- 2023 approved No.193
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of Early Pathophysiology-driven Airway Pressure Release Ventilation (APRVplus) and Time-Controlled Adaptive Ventilation (TCAV) in Acute Respiratory Distress Syndrome (ARDS): a Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT06748807
- Acronym / sponsor ID
- 2023 approved No.193
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 27 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.
In previous studies, airway pressure release ventilation (APRV) has been proven to be an important respiratory support method for ARDS patients, and various APRV ventilation strategies have been proposed. This study aims to compare the physiological effects of two types of APRV ventilation strategy, Early Pathophysiology-driven APRV (APRVplus) and Time-Controlled Adaptive Ventilation (TCAV), through randomized crossover trials, providing evidence for clinical application and further research on APRV.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APRVplus | Experimental | Procedure: APRVplusAn Early Pathophysiology-driven Airway Pressure Release Ventilation |
| TCAV | Other | Procedure: TCAVTime Controlled Adaptive Ventilation (TCAV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- intubated and mechanically ventilated patients
- meet the 2023 global new definition of ARDS
Key exclusion criteria (9 listed)
- Pregnancy
- The expected duration of mechanical ventilation was less than 48 hours
- Intracranial hypertension (suspected or confirmed)
- Neuromuscular disorders that are known to prolong the need for mechanical ventilation
- Known or suspected chronic obstructive pulmonary disease(COPD)
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 |
|---|---|---|
| APRVplusEarly Pathophysiology-driven Airway Pressure Release Ventilation (APRVplus) | Procedure or surgery | APRVplus |
| TCAVTime-Controlled Adaptive Ventilation (TCAV) | Procedure or surgery | TCAV |
Primary outcome
△PL（PLThigh - PLTlow)
Time frame: during the mechanical ventilation procedure
Transpulmonary pressure swings (△PL) equal to PLThigh - PLTlow
3 secondary outcomes
EtCO2
Time frame: during the mechanical ventilation procedure
GI
Time frame: during the mechanical ventilation procedure
PaO2(mmHg)
Time frame: during the mechanical ventilation procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
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?
A study testing APRVplus and TCAV in people with ARDS (Acute Respiratory Distress Syndrome), 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 27 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
△PL（PLThigh - PLTlow) (time frame: during the mechanical ventilation procedure). 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 27 Dec 2024.