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Acute Respiratory Distress Syndrome (ARDS)NCT07669558

Electrical Impedance Tomography-Guided Identification of the Optimal Lateral Position in Postoperative ARDS

A study testing Positioning Intervention in people with Acute Respiratory Distress Syndrome (ARDS) and Postoperative, run by Ruijin Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective, randomized crossover physiological study evaluates the effects of lateral positioning (left lateral position and right lateral position) versus the supine position on ventilation-perfusion (V/Q) matching in adult postoperative abdominal surgery participants with acute respiratory distress syndrome… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Positioning Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
28 Jun 2026to 31 Oct 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

  • Age ≥18 years
  • Postoperative abdominal surgery patients admitted to the ICU with ARDS (Berlin definition)
  • Considered able to tolerate protocolized position changes by the treating team
  • EIT belt placement and protocol procedures feasible
  • Informed consent obtained from the patient or legally authorized representative

Who cannot join

  • Contraindication to lateral positioning (e.g., unstable spine, uncontrolled bleeding, open abdomen, high-risk surgical wound condition)
  • Severe hemodynamic instability or other conditions making participation unsafe
  • High risk of airway/vascular line/drain dislodgement not manageable
  • Pregnancy
  • Refusal of informed consent
  • Any other condition deemed inappropriate by investigators

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
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Department of Critical Care Medicine

    Shanghai

    Rui Zhang, +86 18801119381, ccmzhangrui@foxmail.com

    Recruiting

Other trials in China

About this study

Official title: Effect of Left Lateral, Right Lateral, and Supine Positioning on Ventilation-Perfusion Matching Assessed by Electrical Impedance Tomography in Adult Postoperative Abdominal Surgery Patients With ARDS: A Prospective Randomized Crossover Physiological Study

This prospective, randomized crossover physiological study evaluates the effects of lateral positioning (left lateral position and right lateral position) versus the supine position on ventilation-perfusion (V/Q) matching in adult postoperative abdominal surgery participants with acute respiratory distress syndrome (ARDS). Bedside electrical impedance tomography (EIT) will be used to quantify regional ventilation and perfusion (perfusion derived from an intravenous tracer bolus administered during a brief breath-hold) and to calculate global "normal V/Q" (normal V/Q, %). Oxygenation, respiratory mechanics (when applicable), and hemodynamics will be recorded concurrently. Feasibility and safety of the positioning protocol will also be assessed.

Read the detailed description

Postoperative abdominal surgery patients commonly develop atelectasis, diaphragmatic dysfunction, and heterogeneous ventilation. When complicated by ARDS, ventilation-perfusion mismatch may worsen oxygenation and ventilatory efficiency. Prone positioning may be limited in this population because of abdominal incisions, drains, and intra-abdominal pressure concerns. Lateral positioning is frequently used in critical care and may improve V/Q coupling by changing gravitational gradients, chest wall mechanics, and pulmonary blood flow distribution; however, quantitative bedside evidence comparing left and right lateral positions is limited.

EIT is a radiation-free bedside functional imaging technique that can continuously monitor regional ventilation. In combination with a brief breath-hold and an intravenous tracer bolus, EIT can derive perfusion-related signals, enabling bedside quantification of V/Q matching.

In this randomized crossover study, each participant undergoes three body positions-supine position, left lateral position, and right lateral position-in a randomized order. The sequence (including whether left lateral or right lateral is performed first) is determined by random-number-based randomization. Each position stage lasts 60 minutes. After entering each position, participants are stabilized for 45 minutes before EIT measurements. EIT ventilation recording is obtained after stabilization, followed by an EIT perfusion assessment performed during a breath-hold of at least 8 seconds (actual breath-hold time recorded). During the breath-hold, a rapid intravenous tracer bolus is administered: 10 mL of 10% sodium chloride solution or 10 mL of 5% sodium bicarbonate solution, injected over 2-3 seconds via a central or peripheral venous line. Between position stages, participants return to the supine position for a 45-minute washout period. The primary endpoint is the difference in global normal V/Q (%) among the three positions. Secondary endpoints include other EIT-derived V/Q indices, oxygenation indices, respiratory mechanics, hemodynamic changes, and feasibility/safety outcomes. The primary statistical analysis required a minimum of 22 evaluable participants. Recruitment was planned to achieve at least this number to account for potential dropout. Recruitment would be terminated once sufficient evaluable subjects were obtained.

Being tested
Positioning Intervention
Keywords
acute respiratory distress syndrome (ARDS), electrical impedance tomography (EIT, Lateral position, ventilation-perfusion, postoperative abdominal surgery, crossover study, supine position
Medical subject headings
Respiratory Distress Syndrome, Deception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positioning InterventionBehavioural

    Using a randomized crossover design, all subjects undergo three body position stages in random order. Each position (supine, left lateral, right lateral) is maintained for 60 minutes. Vital signs are stabilized per protocol, followed by EIT assessment of ventilation-perfusion matching.

    1. Position stage duration: 60 minutes.
    2. Stabilization period before measurement: 45 minutes after position change.
    3. Washout: 45-minute supine washout period between position stages.
    4. EIT ventilation measurement: after stabilization in each position.
    5. EIT perfusion measurement: during breath-hold ≥8 seconds (actual breath-hold time recorded.
    6. Tracer bolus: 10 mL of 10% sodium chloride solution OR 10 mL of 5% sodium bicarbonate solution, injected over 2-3 seconds via central or peripheral venous line.
Study groups in NCT07669558
Study groupRoleWhat they receive
Arm 1: Supine PositionExperimentalSupine position with protocolized stabilization and EIT ventilation/perfusion measurements.
Receives: Behavioral: Positioning Intervention
Arm 2: Left Lateral PositionExperimentalLeft lateral position with protocolized stabilization and EIT ventilation/perfusion measurements.
Receives: Behavioral: Positioning Intervention
Right Lateral PositionExperimentalRight lateral position with protocolized stabilization and EIT ventilation/perfusion measurements.
Receives: Behavioral: Positioning Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global normal V/Q (%) derived from electrical impedance tomography (EIT)

    The percentage of lung pixels categorized as "normal ventilation-perfusion (V/Q)" according to pre-defined ventilation and perfusion signals acquired via EIT.

    Measured: Post-stabilization in each body position (supine, left lateral, right lateral); assessments performed once per 60-minute positional stage, with comparative data reported for each position time point.

Secondary outcomes (12)
  1. EIT-derived V/Q mismatch components (shunt-like lung pixel percentage, dead-space-like lung pixel percentage).

    Quantitative ventilation-perfusion mismatch metrics calculated from electrical impedance tomography (EIT) ventilation and perfusion signals, unit: %.

    Shunt-like %: Proportion of lung pixels with high perfusion but negligible ventilation Dead-space-like %: Proportion of lung pixels with robust ventilation but minimal perfusion These two indicators quantify the severity of pulmonary gas exchange disturbance under different body positions.

    Measured: Single assessment time point after respiratory and hemodynamic stabilization within each 60-minute positional stage (left lateral, right lateral); all V/Q mismatch data will be reported separately per positional time point for inter-position comparison.

  2. EIT-derived regional ventilation distribution indices

    A composite set of regional ventilation distribution parameters calculated from EIT signals, including center of ventilation (CoVX, CoVY), dorsal ventilation ratio (DVR), global inhomogeneity index (GI), ventral/dorsal impedance ratio, and ventilation fraction of four predefined ventrodorsal lung regions (ventral, mid-ventral, mid-dorsal, dorsal, expressed as %), used to evaluate regional ventilation uniformity and spatial distribution.

    Measured: Single assessment time point after hemodynamic and respiratory stabilization within each 60-minute positional stage (left lateral, right lateral); comparative data of all indices will be reported separately for each positional assessment time point.

  3. EIT-derived regional perfusion distribution indices

    Quantitative perfusion parameters calculated from electrical impedance tomography (EIT) perfusion signals, including perfusion center coordinates (CoPX, CoPY), dorsal perfusion ratio (DPR), global perfusion inhomogeneity index, regional perfusion delay, and perfusion percentage of four predefined ventrodorsal lung regions (ventral, mid-ventral, mid-dorsal, dorsal, unit: %). These indices quantitatively characterize spatial perfusion redistribution, perfusion homogeneity, and temporal perfusion lag in supine, left lateral and right lateral positions.

    Measured: Single perfusion assessment time point after respiratory and hemodynamic stabilization within each 60-minute positional stage (left lateral, right lateral); all perfusion index data will be reported separately for each positional assessment time point.

  4. Oxygenation index (PaO₂/FiO₂ ratio if arterial blood gas sampling is feasible; SpO₂/FiO₂ ratio as an alternative surrogate index).

    Oxygenation index is calculated to reflect systemic oxygenation status. PaO₂/FiO₂ ratio (unit: mmHg) will be prioritized when arterial blood gas data are available; if arterial blood gas cannot be obtained, SpO₂/FiO₂ ratio will be adopted as the substitute parameter.

    Measured: Single assessment time point after respiratory and hemodynamic stabilization within each 60-minute positional stage (supine, left lateral, right lateral); oxygenation index values will be reported separately for each positional assessment time point.

  5. Ventilator-related pressure parameters (plateau pressure, driving pressure).

    Static respiratory pressure indicators automatically recorded by mechanical ventilator, only collected from participants receiving invasive mechanical ventilation.

    • Plateau pressure: Static airway plateau pressure, unit: cmH₂O
    • Driving pressure: Calculated as plateau pressure minus PEEP, unit: cmH₂O These two pressure metrics reflect alveolar mechanical load under controlled ventilation.

    Measured: Single assessment time point after respiratory and hemodynamic stabilization within each 60-minute positional stage (supine, left lateral, right lateral); all pressure values will be reported separately for each positional assessment time point.

  6. Respiratory system compliance (ventilator-derived parameter).

    A comprehensive respiratory mechanics index calculated as tidal volume divided by driving pressure, unit: mL/cmH₂O. Measurement is limited to invasively ventilated participants to evaluate the overall distensibility of lungs and chest wall.

    Measured: Single assessment time point after respiratory and hemodynamic stabilization within each 60-minute positional stage (supine, left lateral, right lateral; all compliance values will be reported separately for each positional assessment time point.

  7. Circulatory monitoring parameters (heart rate, mean arterial pressure, vasopressor use if available).

    Continuous hemodynamic readings collected via bedside invasive monitor for circulatory assessment.

    • Heart rate: unit: beats per minute (bpm)
    • Mean arterial pressure (MAP): unit: mmHg These two parameters reflect systemic circulatory stability during positional adjustment and EIT perfusion measurement.
    • Binary categorical indicator for vasopressor administration status and continuous dosage recording of vasopressors; administration status (yes/no) and dosage (μg/kg/min) to evaluate circulatory support intensity.

    Measured: Two predefined assessment time points within each 60-minute positional stage (supine, left lateral, right lateral): 1) after full respiratory and hemodynamic stabilization; 2) around breath-hold and contrast bolus injection for perfusion acquisition.

  8. Proportion of participants completing all randomized 60-minute positional stages and inter-position washout periods.

    Binary participant-level endpoint (unit: proportion [%]) calculated as the number of participants who fully finished all three predefined body position stages and corresponding washout intervals divided by total enrolled participants. Used to assess overall study procedural feasibility.

    Measured: Through study positional phase completion (from initiation of the first positional stage to the end of the final washout period following the last positional assessment); completion status data will be summarized across all participants.

  9. Number of participants with successful acquisition of analyzable EIT imaging datasets.

    Count-based feasibility metric (unit: number of participants). Defined as participants with complete, artifact-free EIT ventilation and perfusion images eligible for post-hoc quantitative regional lung function analysis.

    Measured: Through study positional phase completion (from initiation of the first positional stage to the end of the final washout period following the last positional assessment); successful EIT acquisition counts will be aggregated for all enrolled subjects.

  10. Proportion of participants capable of maintaining breath-hold for at least 8 seconds during EIT perfusion imaging.

    Proportional feasibility endpoint (unit: proportion [%]). Calculated as participants who sustained ≥8-second breath-hold during contrast bolus perfusion scans divided by all participants undergoing EIT perfusion measurement.

    Measured: Through positional phase completion (from first positional stage start to final post-position washout end); breath-hold compliance proportions summarized across all perfusion assessment time points.

  11. Number of participants with any procedure-related adverse event (desaturation, hypotension, arrhythmia, accidental tube/line/drain displacement).

    Safety count endpoint (unit: number of participants). Captures all acute adverse events directly associated with positional changes and EIT image acquisition during the study protocol.

    Measured: Through positional phase completion (from first positional stage start to final post-position washout end); all adverse events captured and tallied during positional testing.

  12. Number of participants with early study termination secondary to positional intolerance.

    Tolerability safety metric (unit: number of participants). Records participants withdrawn prematurely from positional testing due to respiratory, hemodynamic or clinical intolerance to supine, left lateral or right lateral positioning.

    Measured: Through positional phase completion (from first positional stage start to final post-position washout end); all early termination events documented and counted for pooled safety analysis.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2026
  2. Study start28 Jun 2026
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

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
Model description
In this randomized crossover study, each participant undergoes three body positions-supine position, left lateral position, and right lateral position-in a randomized order. The sequence (including whether left lateral or right lateral is performed first) is determined by random-number-based randomization. Each position stage lasts 60 minutes. After entering each position, participants are stabilized for 45 minutes before EIT measurements.
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07669558
Sponsor's protocol ID
ARDS-EIT-POS-001
Status last verified
Jun 2026
First submitted
8 Jun 2026
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Positioning Intervention in people with Acute Respiratory Distress Syndrome (ARDS) and Postoperative, run by Ruijin 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 5 inclusion and 6 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 3 Aug 2026. 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 Rui Zhang (+86 18801119381, ccmzhangrui@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global normal V/Q (%) derived from electrical impedance tomography (EIT) (time frame: Post-stabilization in each body position (supine, left lateral, right lateral); assessments performed once per 60-minute positional stage, with comparative data reported for each position time point.). 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 3 Aug 2026.

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