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临床试验/NCT06430554
NCT06430554
招募中
不适用

Personalized Ventilatory Strategy Based on Ventilation-perfusion Mismatch and Lung Recruitability in Moderate-to-severe ARDS Patients

Zhongda Hospital1 个研究点 分布在 1 个国家目标入组 40 人2024年6月8日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Respiratory Distress Syndrome
发起方
Zhongda Hospital
入组人数
40
试验地点
1
主要终点
Ventilation-perfusion matching (V/Q match%)
状态
招募中
最后更新
2个月前

概览

简要总结

This observational study will explore the effects of PEEP and position on regional lung ventilation-perfusion mismatch by electrical impedance tomography (EIT) in moderate-to-severe ARDS patients with different lung recruitability.

详细描述

Acute respiratory distress syndrome (ARDS) is characterized by impaired ventilation-perfusion matching, which not only indicates the severity of the condition but also contributes to ventilation-induced lung injury. Higher positive end-expiratory pressure (PEEP) and prone position could improve ventilation-perfusion mismatch by recruiting collapsed lungs and facilitating more homogeneous ventilation, but these benefits might depend on lung recruitability. The present study aims to elucidate the regional effect of PEEP(low and high) and body position(supine and prone) on the ventilation-perfusion matching. Also endeavors to establish correlations between alterations in ventilation-perfusion matching patterns and the inherent lung recruitability. Participants will be deeply sedated and paralyzed, ventilated in volume-controlled with protective ventilation (tidal volume=6-8 mL/Kg of predicted body weight and respiratory rate set to obtain normal pH). Then the patients will be sequentially assigned to each of four conditions as follows: Low PEEP, supine position; High PEEP, supine position; Low PEEP, prone position; High PEEP, prone position. High PEEP and low PEEP is defined as 15 cmH2O and 5 cmH2O (or airway opening pressure, either of which was higher) respectively. Each measurement (e.g., arterial blood gas analysis, respiratory parameters, hemodynamics, EIT measurements) will be performed at least 15 minutes after changing ventilator settings and at least 1 hour after changing body positions. The timing of turning patients from supine to prone position is determined by the clinical team. To assess lung recruitability, a single-breath derecruitment maneuver will be performed by changing PEEP 15 to 5 cmH2O (or airway opening pressure, either of which was higher) in supine position. Patients with recruitment-inflation ratio over the median value are defined as high recruiters. EIT data will be collected by standard device (Infinity C500, Drager, Germany) with a sample rate of 50 Hz. The EIT belt will be placed directly below the armpits, between the third and fifth intercostal spaces. This positioning of the EIT belt will be maintained consistently during both supine and prone positions. A bolus of 10 ml 5% NaCl will be injected during a respiratory pause (≥8 s) through the central venous catheter to assess lung ventilation and perfusion distributions. The primary endpoint is EIT-based ventilation-perfusion matching (V/Q match%).

注册库
clinicaltrials.gov
开始日期
2024年6月8日
结束日期
2026年6月30日
最后更新
2个月前
研究类型
Observational
性别
All

研究者

发起方
Zhongda Hospital
责任方
Principal Investigator
主要研究者

Fengmei Guo

Director of Intensive Care Unit, Principal Investigator, Clinical Professor, Zhongda Hospital, Southeast University, China

Zhongda Hospital

入排标准

入选标准

  • age ≥18 years
  • Moderate-to-severe ARDS as per the 2023 ESICM definition
  • Undergoing invasive mechanical ventilation
  • Planned prone position based on the attending physicians' decisions
  • Signed informed consent

排除标准

  • age ≥85 years
  • Severe hemodynamic instability (\> 30% increase in vasopressors in the last 6 hours or norepinephrine \> 0.5 µg/kg/min)
  • Clinically suspected elevated intracranial pressure (\>18 mm Hg)
  • Bronchopleural fistula
  • Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)
  • Severe hypernatremia (\>170mmol/L)
  • Re-admission of patients already enrolled in this study, or patients who are participating in other studies

结局指标

主要结局

Ventilation-perfusion matching (V/Q match%)

时间窗: Through study completion (within 24 hours)

corresponding to the pixels that are both ventilated and perfused divided by the total number of pixels ventilated and/or perfused

次要结局

  • percentage of shunt(Through study completion (within 24 hours))
  • percentage of dead space(Through study completion (within 24 hours))
  • Respiratory system compliance(Through study completion (within 24 hours))
  • PaO2/FiO2 ratio(Through study completion (within 24 hours))

研究点 (1)

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