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NCT Number: NCT07375849

Application of Electrical Impedance Tomography in Evaluating Pulmonary Function Improvement After High Lateral Recumbent Position Therapy in ARDS Patients

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome (ARDS) Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Place the patient in the 90-degree high lateral position.

Procedure

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

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

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

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.

Primary outcomes

  1. death

    Time frame: One month after treatment

Secondary outcomes

  1. A/P Ratio

    Time frame: 24 hours before treatment, 24 hours after treatment

  2. Ventilation-Perfusion Ratio

    Time frame: 24 hours before treatment, 24 hours after treatment

  3. Oxygenation index

    Time frame: 24 hours before treatment, 24 hours after treatment

  4. Global Inhomogeneity Index, GI

    Time frame: 24 hours before treatment, 24 hours after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Lijun Song

CONTACT

[email protected]

+8615869252244

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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