ARDS: Acute Respiratory Distress SyndromeNCT06696638
Physiological Effects of Lung Impedance Tomography-Guided and Plat Pressure-Guided Phigh During APRV in Patients With ARDS
A study testing EIT-guided Phigh settings during APRV in people with ARDS: Acute Respiratory Distress Syndrome, run by XiaoJing Zou,MD at 1 site in China.
Trial summary
This study aims to investigate the effects of EIT-guided and Pplat-guided Phigh settings on regional ventilation and perfusion in ARDS patients during APRV, while also examining the impact of different Phigh settings on gas exchange, respiratory mechanics, and hemodynamics. 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?
- EIT-guided Phigh settings during APRV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with ARDS according to the 2023 global new definition of ARDS.
- Age ≥ 18 years.
Who cannot join
- Severe chronic obstructive pulmonary disease, severe asthma, pulmonary bullae, pneumothorax, subcutaneous emphysema, mediastinal emphysema, etc. · Contraindications for EIT, such as chest wound dressing, pacemaker implantation, defibrillator use, etc.
- Pulmonary interstitial disease.
- Uncorrected shock of various types.
- Intracranial hypertension.
- Pregnant and postpartum women.
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
Wuhan Union hospital
Wuhan, Hubei, 237000
xiaojing Zou, MD, 13995518630, 249126734@qq.com
About this study
Official title: Physiological Effects of Lung Impedance Tomography-guided and Plat Pressure-guided Phigh During Airway Pressure Release Ventilation in Patients With Acute Respiratory Distress Syndrome
This study aims to investigate the effects of EIT-guided and Pplat-guided Phigh settings on regional ventilation and perfusion in ARDS patients during APRV, while also examining the impact of different Phigh settings on gas exchange, respiratory mechanics, and hemodynamics.
- Being tested
- EIT-guided Phigh settings during APRV
- Keywords
- ARDS, APRV, EIT, Phigh
- 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.
EIT-guided Phigh settings during APRVDevice
The Phigh level selected for the patients in the Intervention group was the intercept point of cumulated collapse and overdistension percentage curves, providing the best compromise between collapsed and overdistended lung.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | EIT-guided Phigh settings during APRV Receives: Device: EIT-guided Phigh settings during APRV |
| Control group | No intervention | Pplat-guided Phigh settings during APRV |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of Phigh guided by different methods on regional lung ventilation assessed by EIT
Measured: 1 Hour Post-Intervention
Secondary outcomes (5)
Global inhomogeneity assessed by electrical impedance tomography
Measured: 1 Hour Post-Intervention
Center of ventilation assessed by electrical impedance tomography
Measured: 1 Hour Post-Intervention
ventilation/perfusion matching assessed by EIT
Measured: 1 Hour Post-Intervention
Respiratory system compliance
Tidal volume divided by plateau pressure
Measured: 1 Hour Post-Intervention
mean arterial pressure
Measured: 1 Hour Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XiaoJing Zou,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XiaoJing Zou,MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696638
- Sponsor's protocol ID
- APRVPhigh2024
- Status last verified
- Jan 2025
- First submitted
- 13 Nov 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of Lung Impedance Tomography-guided and Plat Pressure-guided Phigh During Airway Pressure Release Ventilation in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT06696638
- Acronym / sponsor ID
- APRVPhigh2024
- Keywords
- ARDS, APRV, EIT, Phigh
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- XiaoJing Zou,MDUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Nov 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.
This study aims to investigate the effects of EIT-guided and Pplat-guided Phigh settings on regional ventilation and perfusion in ARDS patients during APRV, while also examining the impact of different Phigh settings on gas exchange, respiratory mechanics, and hemodynamics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: EIT-guided Phigh settings during APRVEIT-guided Phigh settings during APRV |
| Control group | No intervention | –Pplat-guided Phigh settings during APRV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with ARDS according to the 2023 global new definition of ARDS.
- Age ≥ 18 years.
Key exclusion criteria (5 listed)
- Severe chronic obstructive pulmonary disease, severe asthma, pulmonary bullae, pneumothorax, subcutaneous emphysema, mediastinal emphysema, etc. · Contraindications for EIT, such as chest wound dressing, pacemaker implantation, defibrillator use, etc.
- Pulmonary interstitial disease.
- Uncorrected shock of various types.
- Intracranial hypertension.
- Pregnant and postpartum women.
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 |
|---|---|---|
| EIT-guided Phigh settings during APRVThe Phigh level selected for the patients in the Intervention group was the intercept point of cumulated collapse and overdistension percentage curves, providing the best compromise between collapsed and overdistended lung. | Device | Intervention group |
Primary outcome
The effects of Phigh guided by different methods on regional lung ventilation assessed by EIT
Time frame: 1 Hour Post-Intervention
5 secondary outcomes
Global inhomogeneity assessed by electrical impedance tomography
Time frame: 1 Hour Post-Intervention
Center of ventilation assessed by electrical impedance tomography
Time frame: 1 Hour Post-Intervention
ventilation/perfusion matching assessed by EIT
Time frame: 1 Hour Post-Intervention
Respiratory system compliance
Time frame: 1 Hour Post-Intervention
mean arterial pressure
Time frame: 1 Hour Post-Intervention
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 6 Jan 2025.
- Individual participant dataSharing planned: No
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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?
A study testing EIT-guided Phigh settings during APRV in people with ARDS: Acute Respiratory Distress Syndrome, run by XiaoJing Zou,MD 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 5 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 6 Jan 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?
Contact jing Xiao Zou (+862785351606, 249126734@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of Phigh guided by different methods on regional lung ventilation assessed by EIT (time frame: 1 Hour Post-Intervention). 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 6 Jan 2025.