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临床试验/NCT07504731
NCT07504731招募中不适用

Impact of Trunk Inclination on Lung Mechanics According to PEEP and Reruitability

Zhongda Hospital3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年3月20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
发起方
入组人数
40
试验地点
3
主要终点
Transpulmonary driving pressure (ΔPL)

研究概览

简要总结

This multicenter, physiological, observational study hypothesizes that in moderate to severe ARDS, trunk inclination unloads the chest wall, but its impact on lung mechanics depends on PEEP levels and lung recruitability.

详细描述

There is near-universal agreement among caregivers that head-up positioning is beneficial for mechanically ventilated patients. In most intensive care units, a semi-recumbent position (head of bed elevated 30-45°) has therefore become standard practice, except when absolutely contraindicated. This widespread adoption is driven primarily by robust clinical evidence showing that trunk inclination reduces the incidence of ventilator-associated pneumonia. In patients under general anesthesia, physiological studies showed a clear mechanistic benefit: the vector of abdominal weight shifts caudally, increasing resting lung volume and thereby decreasing the tendency for atelectasis formation.

In patients with acute respiratory distress syndrome (ARDS), however, the physiological consequences of trunk inclination remain undecided. Here, the descent of the diaphragm in the head-up position increases transpulmonary pressure (PL) at end-expiration, which tends to recruit previously collapsed lung units. Yet the "baby lung" of ARDS, the markedly reduced aerated lung volume, operates on widely different segments of its pressure-volume curve (i.e. the lower flat portion, the steep linear portion, or the upper flat portion). Consequently, the net effect of the rise in end-expiratory PL depends on whether recruitment of additional units outweighs overdistension of those already open.

Theoretically, for example, in patients with high lung recruitability but insufficient PEEP, trunk inclination should tilt the balance toward recruitment; in the same patients receiving excessive PEEP, the same maneuver may instead promote overdistension. To date, however, neither the overall effect of trunk inclination nor the modulating roles played by PEEP level and lung recruitability have been adequately assessed. Previous studies have almost invariably assessed trunk inclination at a single fixed PEEP without quantifying lung recruitability, thereby limiting the generalizability of their findings and leaving unresolved the complex interactions among posture, PEEP, chest-wall mechanics, and recruitability.

To address these critical gaps, the investigators designed this multicenter, physiological, observational study. The investigators hypothesized that, in moderate to severe ARDS, trunk inclination unloads the chest wall and that its net impact on lung mechanics is fundamentally determined by the prevailing PEEP level and the individual level of lung recruitability.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Intubated moderate and severe ARDS according to the Berlin definition (PaO2/FiO2 ratio <= 200 mmHg)
  • Under continuous sedation with or without paralysis

排除标准

  • Age <18 years
  • Bronchopleural fistula
  • Pure COPD exacerbation
  • Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)
  • Hemodynamic instability (Systolic BP < 75 mmHg or MAP < 60 mmHg despite vasopressors and/or heart rate < 55 bpm)
  • Contraindications to mobilization (e.g., intracranial hypertension, spinal cord injury)
  • Intra-abdominal hypotension (IAP≥12mmHg)
  • Pregnancy
  • Attending physician deems the transient application of high airway pressures to be unsafe

研究组 & 干预措施

Intubated mechanically ventilated ARDS patients

Intubated mechanically ventilated patients with moderate to severe ARDS according to the Berlin definition

干预措施: Specific lung recruitment maneuvers and decremental PEEP steps (Other)

结局指标

主要结局

Transpulmonary driving pressure (ΔPL)

时间窗: 2 hour

Physiological parameter calculated as end-inspiratory transpulmonary pressure minus end-expiratory transpulmonary pressure. Transpulmonary pressure is monitored continuously in real time using an esophageal balloon catheter.

次要结局

  • Percentage of overdistension and collapse(2 hours)
  • Lung compliance (Clung)(2 hours)
  • Respiratory system compliance (Crs)(2 hours)
  • Chest wall compliance (Ccw)(2 hours)
  • Recruitment-to-inflation (R/I) ratio(2 hours)
  • Lung recruitability (ΔCollapse24-6)(2 hours)

研究者

发起方
Zhongda Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fengmei Guo

Deputy director

Zhongda Hospital

研究点 (3)

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