Acute Respiratory Distress SyndromeNCT05767125
Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS
A study testing APRV and LTV in people with Acute Respiratory Distress Syndrome, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Low tidal volume ventilation (LTV) has been proposed and widely used in patients with acute respiratory distress syndrome (ARDS) to prevent ventilator-induced lung injury (VILI) and mitigate its effects. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- APRV and LTV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 and ≤80 years;
- Moderate-to-severe ARDS patients according to the Berlin definition;
- Endotracheal mechanical ventilation ≤48 h before enrollment;
- Expected to require continuous invasive mechanical ventilation ≥72 h.
Who cannot join
- Severe chronic obstructive pulmonary disease, severe asthma, pulmonary bulla, subcutaneous emphysema, mediastinal emphysema, etc;
- Contraindications to the use of electrical impedance tomography (e.g., chest surgical wounds dressing or presence of pacemaker)；
- Pulmonary interstitial lesions；
- End-stage of chronic disease, with an expected survival period of <6 months；
- Body mass index >35 kg/m2;
- Refractory shock；
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- Intracranial hypertension；
- Pregnant and parturient woman；
- Intra-abdominal pressure persisted > 20 mmHg and could not be relieved within 24 hours；
- Severe thoracic deformity；
- Severe cardiac dysfunction；
- Atrial fibrillation and other malignant arrhythmias that seriously affect cardiac output；
- Pulmonary embolism；
- Extracorporeal membrane oxygenation is needed；
- Prone positioning was performed before randomization；
- Patients who have participated in other clinical trials within 30 days；
- Patients who have not signed informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Yongran WU, master, 18627004016 ext. 027-85351607, 974528836@qq.com
About this study
Official title: Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS: a Single-center, Pilot Randomized Controlled Study
Low tidal volume ventilation (LTV) has been proposed and widely used in patients with acute respiratory distress syndrome (ARDS) to prevent ventilator-induced lung injury (VILI) and mitigate its effects. The LTV strategy is intended to protect the "baby lung" from overdistension while simultaneously allowing acutely injured tissue to continually collapse. Airway pressure release ventilation (APRV) is a highly effective strategy improving lung recruitment and oxygenation in clinical studies, but its effects on lung injury and mortality is debatable. Animal studies revealed that APRV could normalize post-injury heterogeneity and reduce the risk of VILI. Our objective was to investigate the impact of APRV and LTV on regional ventilation and perfusion distribution in ARDS patients by electrical impedance tomography (EIT).
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- APRV, LTV
- 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.
APRVDevice
Patients with moderate-to-severe ARDS were supported with APRV.
LTVDevice
Patients with moderate-to-severe ARDS were supported with LTV.
| Study group | Role | What they receive |
|---|---|---|
| APRV Group | Experimental | Patients with moderate-to-severe ARDS were supported with APRV. Receives: Device: APRV |
| LTV Group | Active comparator | Patients with moderate-to-severe ARDS were supported with LTV. Receives: Device: LTV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung ventilation/perfusion matching
Lung ventilation/perfusion matching assessed by EIT
Measured: 24hour
Secondary outcomes (11)
Lung ventilation distrubution
Lung ventilation distrubution assessed by EIT
Measured: up to 72hour
Lung perfusion distrubution
Lung perfusion distrubution assessed by EIT
Measured: up to 72hour
Dead-space% and shunting%
Lung Dead-space% and shunting% assessed by EIT
Measured: up to 72hour
Oxygenation index
Oxygenation index=Arterial partial pressure of oxygen /fraction of inspired oxygen
Measured: up to 72hour
Arterial partial pressure of carbon dioxide (PaCO2)
PaCO2 is one of the key indicators of pulmonary ventilation which can be obtained from arterial blood gas analysis.
Measured: up to 72hour
Static respiratory compliance (Crs)
Crs=tidal volume/driving pressure
Measured: up to 72hour
Cardiac output
Cardiac output assessed by echocardiography
Measured: up to 72hour
Right ventricular function
Right ventricular function assessed by echocardiography
Measured: up to 72hour
Ventilator free days
28d-ventilator free days after randomization
Measured: up to 28days
Duration of Intensive care units stay
28d-duration of Intensive care units stay after randomization
Measured: up to 28days
Mortality after randomization
28d-all-cause mortality
Measured: up to 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 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 Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XiaoJing Zou,MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- You Shang, prof., Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767125
- Sponsor's protocol ID
- WUHICU202302
- Status last verified
- Mar 2023
- First submitted
- 16 Feb 2023
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zou X, Zhang H, Wu Y, Li R, Gao X, Wang A, Zhao X, Yang X, Shu H, Qi H, Fu Z, Yuan S, Ma Y, Yang L, Shang Y, Zhao Z. Physiologic Comparison of Airway Pressure Release Ventilation and Low Tidal Volume Ventilation in ARDS: A Randomized Controlled Trial. Chest. 2025 Feb;167(2):453-465. doi: 10.1016/j.chest.2024.08.050. Epub 2024 Sep 17.
PubMed 39299389
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS: a Single-center, Pilot Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05767125
- Acronym / sponsor ID
- WUHICU202302
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Mar 2023 (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.
Low tidal volume ventilation (LTV) has been proposed and widely used in patients with acute respiratory distress syndrome (ARDS) to prevent ventilator-induced lung injury (VILI) and mitigate its effects. The LTV strategy is intended to protect the "baby lung" from overdistension while simultaneously allowing acutely injured tissue to continually collapse. Airway pressure release ventilation (APRV) is a highly effective strategy improving lung recruitment and oxygenation in clinical studies, but its effects on lung injury and mortality is debatable. Animal studies revealed that APRV could normalize post-injury heterogeneity and reduce the risk of VILI. Our objective was to investigate the impact of APRV and LTV on regional ventilation and perfusion distribution in ARDS patients by electrical impedance tomography (EIT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APRV Group | Experimental | Device: APRVPatients with moderate-to-severe ARDS were supported with APRV. |
| LTV Group | Active comparator | Device: LTVPatients with moderate-to-severe ARDS were supported with LTV. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥18 and ≤80 years;
- Moderate-to-severe ARDS patients according to the Berlin definition;
- Endotracheal mechanical ventilation ≤48 h before enrollment;
- Expected to require continuous invasive mechanical ventilation ≥72 h.
Key exclusion criteria (17 listed)
- Severe chronic obstructive pulmonary disease, severe asthma, pulmonary bulla, subcutaneous emphysema, mediastinal emphysema, etc;
- Contraindications to the use of electrical impedance tomography (e.g., chest surgical wounds dressing or presence of pacemaker)；
- Pulmonary interstitial lesions；
- End-stage of chronic disease, with an expected survival period of <6 months；
- Body mass index >35 kg/m2;
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 |
|---|---|---|
| APRVPatients with moderate-to-severe ARDS were supported with APRV. | Device | APRV Group |
| LTVPatients with moderate-to-severe ARDS were supported with LTV. | Device | LTV Group |
Primary outcome
Lung ventilation/perfusion matching
Time frame: 24hour
Lung ventilation/perfusion matching assessed by EIT
11 secondary outcomes
Lung ventilation distrubution
Time frame: up to 72hour
Lung perfusion distrubution
Time frame: up to 72hour
Dead-space% and shunting%
Time frame: up to 72hour
Oxygenation index
Time frame: up to 72hour
Arterial partial pressure of carbon dioxide (PaCO2)
Time frame: up to 72hour
Static respiratory compliance (Crs)
Time frame: up to 72hour
Cardiac output
Time frame: up to 72hour
Right ventricular function
Time frame: up to 72hour
Ventilator free days
Time frame: up to 28days
Duration of Intensive care units stay
Time frame: up to 28days
Mortality after randomization
Time frame: up to 28days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Derived from this study: PubMed 39299389Zou X, Zhang H, Wu Y, Li R, Gao X, Wang A, Zhao X, Yang X, Shu H, Qi H, Fu Z, Yuan S, Ma Y, Yang L, Shang Y, Zhao Z. Physiologic Comparison of Airway Pressure Release Ventilation and Low Tidal Volume Ventilation in ARDS: A Randomized Controlled Trial. Chest. 2025 Feb;167(2):453-465. doi: 10.1016/j.chest.2024.08.050. Epub 2024 Sep 17.
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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.
You Shang, prof. principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APRV and LTV in people with Acute Respiratory Distress Syndrome, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 4 inclusion and 17 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 14 Mar 2023. 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 Xiaojing Zou, prof. (+862785351606, 249126734@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung ventilation/perfusion matching (time frame: 24hour). 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 NCT05767125, 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 14 Mar 2023.