跳至主要内容
临床试验/NCT07669558
NCT07669558招募中不适用

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

Ruijin Hospital2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2026年6月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
22
试验地点
2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

盲法说明

Participants complete all three positions in a randomized sequence. The order is generated using random numbers, and the random sequence determines whether the left lateral position or right lateral position is performed first. Blinding is not feasible because of the nature of positioning.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Arm 1: Supine Position

Experimental

Supine position with protocolized stabilization and EIT ventilation/perfusion measurements.

干预措施: Positioning Intervention (Behavioral)

Arm 2: Left Lateral Position

Experimental

Left lateral position with protocolized stabilization and EIT ventilation/perfusion measurements.

干预措施: Positioning Intervention (Behavioral)

Right Lateral Position

Experimental

Right lateral position with protocolized stabilization and EIT ventilation/perfusion measurements.

干预措施: Positioning Intervention (Behavioral)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验