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

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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
• Процедура 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
• Процедура 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.

Первичные конечные точки

• death [Срок оценки: One month after treatment]

Вторичные конечные точки (4)

• A/P Ratio [Срок оценки: 24 hours before treatment, 24 hours after treatment]
• Ventilation-Perfusion Ratio [Срок оценки: 24 hours before treatment, 24 hours after treatment]
• Oxygenation index [Срок оценки: 24 hours before treatment, 24 hours after treatment]
• Global Inhomogeneity Index, GI [Срок оценки: 24 hours before treatment, 24 hours after treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07375849 · KY-2025-143

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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