Electrical Impedance Tomography-Guided Identification of the Optimal Lateral Position in Postoperative ARDS
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Positioning Intervention.
- Кому может быть актуально
- Состояния в реестре: Acute Respiratory Distress Syndrome (ARDS), Postoperative. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
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
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Positioning Intervention
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 measur
Первичные конечные точки
- Global normal V/Q (%) derived from electrical impedance tomography (EIT) [Срок оценки: 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.]
Вторичные конечные точки (12)
- EIT-derived V/Q mismatch components (shunt-like lung pixel percentage, dead-space-like lung pixel percentage). [Срок оценки: 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.]
- EIT-derived regional ventilation distribution indices [Срок оценки: 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.]
- EIT-derived regional perfusion distribution indices [Срок оценки: 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.]
- Oxygenation index (PaO₂/FiO₂ ratio if arterial blood gas sampling is feasible; SpO₂/FiO₂ ratio as an alternative surrogate index). [Срок оценки: 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.]
- Ventilator-related pressure parameters (plateau pressure, driving pressure). [Срок оценки: 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.]
- Respiratory system compliance (ventilator-derived parameter). [Срок оценки: 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.]
- Circulatory monitoring parameters (heart rate, mean arterial pressure, vasopressor use if available). [Срок оценки: 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.]
- Proportion of participants completing all randomized 60-minute positional stages and inter-position washout periods. [Срок оценки: 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.]
- Number of participants with successful acquisition of analyzable EIT imaging datasets. [Срок оценки: 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.]
- Proportion of participants capable of maintaining breath-hold for at least 8 seconds during EIT perfusion imaging. [Срок оценки: 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.]
- Number of participants with any procedure-related adverse event (desaturation, hypotension, arrhythmia, accidental tube/line/drain displacement). [Срок оценки: Through positional phase completion (from first positional stage start to final post-position washout end); all adverse events captured and tallied during positional testing.]
- Number of participants with early study termination secondary to positional intolerance. [Срок оценки: 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.]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Department of Critical — Шанхай
Идентификаторы
NCT: NCT07669558 · ARDS-EIT-POS-001