Acute Respiratory Distress SyndromeNCT03549910
A Multicenter, Random Control Study :Early Use of Airway Pressure Release Ventilation (APRVplus) Protocol in ARDS
A study testing APRVplus protocol and Low tidal volume ventilation in people with Acute Respiratory Distress Syndrome, run by West China Hospital at 1 site in China.
Trial summary
Animal experimentals have shown that the more physiology-driven airway pressure release ventilation (APRV) methodologies in ARDS may significantly improve alveolar recruitment and gas exchange, increased homogeneity, and attenuate lung injury, without circulatory depression, as compared with conventional low tial… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- APRVplus protocol and Low tidal volume ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2020to 30 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate and severe acute respiratory distress syndrome,according to the Berlin definition of ARDS
- receiving tracheal intubation and mechanical ventilation was no longer than 48 hours
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.
China1 site, 1 recruiting
- Recruiting
West China Hospital,Sichuan University
Chengdu, Sichuan, 610041
Yan Kang, MD, 86-18980601566, kang_yan_123@163.com
Yongfang Zhou, MM, 86-18980606418, zyfmg@163.com
About this study
Official title: A Multicenter, Random Control Study: Early Use of Airway Pressure Release Ventilation Updated (APRVplus) Protocol in Acute Respiratory Disease Syndrome (ARDS)
Animal experimentals have shown that the more physiology-driven airway pressure release ventilation (APRV) methodologies in ARDS may significantly improve alveolar recruitment and gas exchange, increased homogeneity, and attenuate lung injury, without circulatory depression, as compared with conventional low tial volume lung protective ventilation. our previous single centre,random control study showed that clinical benefit for early use of APRV in ARDS. Nonetheless, clinical data on ARDS are still limited, most of them derived from small clinical trials in which variable outdated APRV settings were used, consequently, the findings of these studies were controversial.
Additionally, the previous single-centre,random control study showed that clinical benefit for APRV.Therefore,the investigators are ready to design a multiple centres,random control study to further verify the effect of APRV plus protocol in ARDS.
Read the detailed description
All the patients included will be randomly assigned to receiving APRV plus protocol or low tidal volume ventilation.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- APRVplus protocol, Low tidal volume ventilation
- 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.
APRVplus protocolProcedure or surgery
Physiology-driven APRVplus protocol
Low tidal volume ventilationProcedure or surgery
Low tidal volume lung protective ventilation
| Study group | Role | What they receive |
|---|---|---|
| Early use of APRVplus protocol in ARDS | Experimental | physiology-driven APRVplus protocol Receives: Procedure: APRVplus protocol |
| Low tidal volume ventilation | Other | Low tidal volume lung protective ventilation Receives: Procedure: Low tidal volume ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
mortality at Day28
Measured: Day 28
Secondary outcomes (7)
Mechanical ventilation free days
Mechanical ventilation free days at Day28
Measured: Day 28
oxygenation
oxygenation index:PaO2:fiO2
Measured: from enrollment to Day7
repiratory system compliance
static repiratory system compliance (ml/cmH2O)
Measured: from enrollment to Day7
MAP
mean arterial pressure
Measured: during the mechanical ventilation procedure
sedation depth
RASS scores
Measured: during the mechanical ventilation procedure
Sedative drug
the total dose of Sedative drug
Measured: during the mechanical ventilation procedure
successful extubation rate
the rate of successful extubation
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 posted8 Jun 2018
- Study start10 Dec 2020
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kang Yan, West China Hospital
- Investigators
- Kang Yan, Study chair, Department of Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549910
- Sponsor's protocol ID
- Huaxi ICU-APRV
- Status last verified
- Apr 2024
- First submitted
- 15 May 2018
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou Y, Cheng J, Zhu S, Dong M, Lv Y, Jing X, Kang Y. Early pathophysiology-driven airway pressure release ventilation versus low tidal volume ventilation strategy for patients with moderate-severe ARDS: study protocol for a randomized, multicenter, controlled trial. BMC Pulm Med. 2024 May 23;24(1):252. doi: 10.1186/s12890-024-03065-y.
PubMed 38783268
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Random Control Study: Early Use of Airway Pressure Release Ventilation Updated (APRVplus) Protocol in Acute Respiratory Disease Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT03549910
- Acronym / sponsor ID
- Huaxi ICU-APRV
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 8 Jun 2018 (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.
Animal experimentals have shown that the more physiology-driven airway pressure release ventilation (APRV) methodologies in ARDS may significantly improve alveolar recruitment and gas exchange, increased homogeneity, and attenuate lung injury, without circulatory depression, as compared with conventional low tial volume lung protective ventilation. our previous single centre,random control study showed that clinical benefit for early use of APRV in ARDS. Nonetheless, clinical data on ARDS are still limited, most of them derived from small clinical trials in which variable outdated APRV settings were used, consequently, the findings of these studies were controversial.
Additionally, the previous single-centre,random control study showed that clinical benefit for APRV.Therefore,the investigators are ready to design a multiple centres,random control study to further verify the effect of APRV plus protocol in ARDS.
Detailed description
All the patients included will be randomly assigned to receiving APRV plus protocol or low tidal volume ventilation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early use of APRVplus protocol in ARDS | Experimental | Procedure: APRVplus protocolphysiology-driven APRVplus protocol |
| Low tidal volume ventilation | Other | Procedure: Low tidal volume ventilationLow tidal volume lung protective ventilation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate and severe acute respiratory distress syndrome,according to the Berlin definition of ARDS
- receiving tracheal intubation and mechanical ventilation was no longer than 48 hours
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 |
|---|---|---|
| APRVplus protocolPhysiology-driven APRVplus protocol | Procedure or surgery | Early use of APRVplus protocol in ARDS |
| Low tidal volume ventilationLow tidal volume lung protective ventilation | Procedure or surgery | Low tidal volume ventilation |
Primary outcome
mortality
Time frame: Day 28
mortality at Day28
7 secondary outcomes
Mechanical ventilation free days
Time frame: Day 28
oxygenation
Time frame: from enrollment to Day7
repiratory system compliance
Time frame: from enrollment to Day7
MAP
Time frame: during the mechanical ventilation procedure
sedation depth
Time frame: during the mechanical ventilation procedure
Sedative drug
Time frame: during the mechanical ventilation procedure
successful extubation rate
Time frame: during the mechanical ventilation procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Derived from this study: PubMed 38783268Zhou Y, Cheng J, Zhu S, Dong M, Lv Y, Jing X, Kang Y. Early pathophysiology-driven airway pressure release ventilation versus low tidal volume ventilation strategy for patients with moderate-severe ARDS: study protocol for a randomized, multicenter, controlled trial. BMC Pulm Med. 2024 May 23;24(1):252. doi: 10.1186/s12890-024-03065-y.
- 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.
Kang Yan study chair
Department of Critical Care Medicine
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 protocol and Low tidal volume ventilation in people with 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: status not confirmed, as of the sponsor's last update on 12 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 Yongfang Zhou (86 18140212276, zyfmg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03549910, which also lists 1 linked publication.
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 12 Apr 2024.