Acute Respiratory Distress Syndrome (ARDS)NCT07375849
Application of Electrical Impedance Tomography in Evaluating Pulmonary Function Improvement After High Lateral Recumbent Position Therapy in ARDS Patients
A study testing Place the patient in the 90-degree high lateral position., Place the patient in the 30-degree low lateral position. and Place the patient in the 120-degree high lateral position. in people with Acute Respiratory Distress Syndrome (ARDS), run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
Trial summary
This randomized controlled trial investigates the effects of prone positioning versus lateral positioning at different angles (30°, 90°, 120°) on pulmonary function improvement in patients with acute respiratory distress syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- Place the patient in the 90-degree high lateral position., Place the patient in the 30-degree low lateral position. and Place the patient in the 120-degree high lateral position.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Dec 2027
- 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
- Age >= 18 years.
- Diagnosis of ARDS according to the Berlin Definition (2023 update).
- Clinically evaluated as suitable for positional therapy by physicians.
- Signed informed consent obtained from the patient or legal representative.
- Absence of severe spinal deformities or musculoskeletal disorders that may compromise safe high lateral positioning.
- No severe skin conditions (e.g., extensive open wounds or pressure ulcers) that may affect the feasibility of lateral positioning.
Who cannot join
- Pregnant or lactating women.
- Severe cardiac diseases (e.g., unstable arrhythmia or heart failure) that may worsen with positional changes.
- Severe coagulation disorders with increased bleeding risk.
- Known allergy to the EIT device or any of its components.
- Severe psychiatric disorders impairing study compliance.
- Current participation in experimental therapies that may affect pulmonary function.
- Severe active infections requiring special isolation measures.
- Anticipated need for emergency surgery or life-threatening complications within 24 hours.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This randomized controlled trial investigates the effects of prone positioning versus lateral positioning at different angles (30°, 90°, 120°) on pulmonary function improvement in patients with acute respiratory distress syndrome (ARDS). Utilizing electrical impedance tomography (EIT) technology, the study monitors key parameters including ventilation distribution and ventilation-perfusion matching in real time, while integrating respiratory mechanics and blood gas analysis data to comprehensively evaluate the therapeutic efficacy of positional adjustments. The study hypothesizes that high-angle lateral positioning may reduce adverse complications associated with prone positioning while effectively improving oxygenation and pulmonary function. The ultimate objective is to provide a safer and more personalized positional therapy regimen for clinical practice, optimizing ARDS treatment strategies to reduce mortality and enhance patient survival outcomes.
- Being tested
- Place the patient in the 90-degree high lateral position., Place the patient in the 30-degree low lateral position., Place the patient in the 120-degree high lateral position., Patients will be placed in the prone position, i.e., lying face down.
- 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.
Place the patient in the 90-degree high lateral position.Procedure or surgery
For the 90° lateral recumbent position group, patients will be rotated between corresponding lateral recumbent positions on the left and right sides every 2 hours, spending 8 hours on each side for a total treatment duration of 16 hours. During each rotation, the nursing team will ensure the patient is safely transferred from one side to the other while maintaining the prescribed lateral angle. Wedge pillows or specialized turning pads will be used to assist in positioning, with supports placed beneath the patient's back and buttocks to alleviate pressure points.
Place the patient in the 30-degree low lateral position.Procedure or surgery
For the 30° lateral recumbent position group, patients will be rotated between left and right lateral recumbent positions at the corresponding angles every 2 hours, spending 8 hours on each side for a total treatment duration of 16 hours. During each rotation, the nursing team will ensure the patient is safely transferred from one side to the other while maintaining the prescribed lateral angle. Wedge pillows or specialized turning pads will be used to assist in positioning, with supports placed beneath the patient's back and buttocks to alleviate pressure points.
Translated with DeepL.com (free version)
Place the patient in the 120-degree high lateral position.Procedure or surgery
For the 120° lateral recumbent position group, patients will be rotated between corresponding lateral recumbent positions on the left and right sides every 2 hours, spending 8 hours on each side for a total treatment duration of 16 hours. During each rotation, the nursing team will ensure the patient is safely transferred from one side to the other while maintaining the prescribed lateral angle. Wedge pillows or specialized turning pads will be used to assist in positioning, with supports placed under the patient's back and buttocks to alleviate pressure points.
Translated with DeepL.com (free version)
Patients will be placed in the prone position, i.e., lying face down.Procedure or surgery
Patients will be positioned in the prone position, lying face down, with specialized prone positioning devices or pillows supporting the head and chest to ensure airway patency. Daily prone therapy duration is set according to clinical guidelines, typically lasting 16 hours.
| Study group | Role | What they receive |
|---|---|---|
| 90-degree high lateral position group | Experimental | Place the patient in the 90-degree high lateral position. Receives: Procedure: Place the patient in the 90-degree high lateral position. |
| 30-degree low lateral position group | Experimental | Place the patient in the 30-degree low lateral position. Receives: Procedure: Place the patient in the 30-degree low lateral position. |
| 120-degree high lateral position group | Experimental | Place the patient in the 120-degree high lateral position. Receives: Procedure: Place the patient in the 120-degree high lateral position. |
| Prone position group | Active comparator | Patients will be placed in the prone position, i.e., lying face down. Receives: Procedure: Patients will be placed in the prone position, i.e., lying face down. |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
Measured: One month after treatment
Secondary outcomes (4)
A/P Ratio
Measured: 24 hours before treatment, 24 hours after treatment
Ventilation-Perfusion Ratio
Measured: 24 hours before treatment, 24 hours after treatment
Oxygenation index
Measured: 24 hours before treatment, 24 hours after treatment
Global Inhomogeneity Index, GI
Measured: 24 hours before treatment, 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (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 Syndrome (ARDS)Studies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375849
- Sponsor's protocol ID
- KY-2025-143
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- 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 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Electrical Impedance Tomography in Evaluating Pulmonary Function Improvement After High Lateral Recumbent Position Therapy in ARDS Patients
- ClinicalTrials.gov ID
- NCT07375849
- Acronym / sponsor ID
- KY-2025-143
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 29 Jan 2026 (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 randomized controlled trial investigates the effects of prone positioning versus lateral positioning at different angles (30°, 90°, 120°) on pulmonary function improvement in patients with acute respiratory distress syndrome (ARDS). Utilizing electrical impedance tomography (EIT) technology, the study monitors key parameters including ventilation distribution and ventilation-perfusion matching in real time, while integrating respiratory mechanics and blood gas analysis data to comprehensively evaluate the therapeutic efficacy of positional adjustments. The study hypothesizes that high-angle lateral positioning may reduce adverse complications associated with prone positioning while effectively improving oxygenation and pulmonary function. The ultimate objective is to provide a safer and more personalized positional therapy regimen for clinical practice, optimizing ARDS treatment strategies to reduce mortality and enhance patient survival outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 90-degree high lateral position group | Experimental | Procedure: Place the patient in the 90-degree high lateral position.Place the patient in the 90-degree high lateral position. |
| 30-degree low lateral position group | Experimental | Procedure: Place the patient in the 30-degree low lateral position.Place the patient in the 30-degree low lateral position. |
| 120-degree high lateral position group | Experimental | Procedure: Place the patient in the 120-degree high lateral position.Place the patient in the 120-degree high lateral position. |
| Prone position group | Active comparator | Procedure: Patients will be placed in the prone position, i.e., lying face down.Patients will be placed in the prone position, i.e., lying face down. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >= 18 years.
- Diagnosis of ARDS according to the Berlin Definition (2023 update).
- Clinically evaluated as suitable for positional therapy by physicians.
- Signed informed consent obtained from the patient or legal representative.
- Absence of severe spinal deformities or musculoskeletal disorders that may compromise safe high lateral positioning.
Key exclusion criteria (8 listed)
- Pregnant or lactating women.
- Severe cardiac diseases (e.g., unstable arrhythmia or heart failure) that may worsen with positional changes.
- Severe coagulation disorders with increased bleeding risk.
- Known allergy to the EIT device or any of its components.
- Severe psychiatric disorders impairing study compliance.
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 |
|---|---|---|
| Place the patient in the 90-degree high lateral position.For the 90° lateral recumbent position group, patients will be rotated between corresponding lateral recumbent positions on the left and right sides every 2 hours, spending 8 hours on each side for a total treatment duration of 16 hours. During each rotation, the nursing team will ensure the patient is safely transferred from one side to the other while maintaining the prescribed lateral angle. Wedge pillows or specialized turning pads will be used to assist in positioning, with supports placed beneath the patient's back and buttocks to alleviate pressure points. | Procedure or surgery | 90-degree high lateral position group |
| Place the patient in the 30-degree low lateral position.For the 30° lateral recumbent position group, patients will be rotated between left and right lateral recumbent positions at the corresponding angles every 2 hours, spending 8 hours on each side for a total treatment duration of 16 hours. During each rotation, the nursing team will ensure the patient is safely transferred from one side to the other while maintaining the prescribed lateral angle. Wedge pillows or specialized turning pads will be used to assist in positioning, with supports placed beneath the patient's back and buttocks to alleviate pressure points. Translated with DeepL.com (free version) | Procedure or surgery | 30-degree low lateral position group |
| Place the patient in the 120-degree high lateral position.For the 120° lateral recumbent position group, patients will be rotated between corresponding lateral recumbent positions on the left and right sides every 2 hours, spending 8 hours on each side for a total treatment duration of 16 hours. During each rotation, the nursing team will ensure the patient is safely transferred from one side to the other while maintaining the prescribed lateral angle. Wedge pillows or specialized turning pads will be used to assist in positioning, with supports placed under the patient's back and buttocks to alleviate pressure points. Translated with DeepL.com (free version) | Procedure or surgery | 120-degree high lateral position group |
| Patients will be placed in the prone position, i.e., lying face down.Patients will be positioned in the prone position, lying face down, with specialized prone positioning devices or pillows supporting the head and chest to ensure airway patency. Daily prone therapy duration is set according to clinical guidelines, typically lasting 16 hours. | Procedure or surgery | Prone position group |
Primary outcome
death
Time frame: One month after treatment
4 secondary outcomes
A/P Ratio
Time frame: 24 hours before treatment, 24 hours after treatment
Ventilation-Perfusion Ratio
Time frame: 24 hours before treatment, 24 hours after treatment
Oxygenation index
Time frame: 24 hours before treatment, 24 hours after treatment
Global Inhomogeneity Index, GI
Time frame: 24 hours before treatment, 24 hours after treatment
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 29 Jan 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Place the patient in the 90-degree high lateral position., Place the patient in the 30-degree low lateral position. and Place the patient in the 120-degree high lateral position. in people with Acute Respiratory Distress Syndrome (ARDS), run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
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 6 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: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Lijun Song (+8615869252244, lijun-song@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: One month after treatment). 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 29 Jan 2026.