跳至主要内容
临床试验/NCT07750288
NCT07750288招募中不适用

Role of Dyspnea in the Progression of Pediatric Acute Respiratory Distress Syndrome

Universidad Nacional Andres Bello1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2026年7月13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
68
试验地点
1
主要终点
Success or Failure of the Intervention

研究概览

简要总结

Pediatric acute respiratory distress syndrome (ARDS) is a life-threatening clinical syndrome, and dyspnea is its key symptom. Strenuous respiratory effort is a "second hit" for ARDS lungs, inducing changes in regional lung aeration and amplifying lung damage in preclinical studies, a phenomenon known as "patient self-inflicted lung injury". In a clinical setting, clinicians are concerned about the possible connection between dyspnea and ARDS progression based on indirect evidence, such as the worse outcomes associated with delayed intubation or failed weaning from mechanical ventilation. Dyspnea is hard to quantify due to its subjective nature. Still, it can be assessed through its interrelated and independent components: respiratory drive (neural stimuli), respiratory effort (muscle contraction), and work of breathing (energy expenditure).

This project aims to identify mechanical thresholds of dyspnea components to predict early ARDS progression and outcome. The role of respiratory effort is particularly relevant in three phases of ARDS where a transition between spontaneous and controlled ventilation occurs: 1) acute phase, when clinicians try to prevent mechanical ventilation (MV) through non-invasive support; 2) intermediate phase, transitioning from controlled to assisted MV; and 3) late phase, during weaning from MV. These transitions are challenging because it is difficult for clinicians to titrate adequate support and avoid both under- and over-assistance.

In critically ill children, there are no established thresholds for dyspnea components that predict ARDS progression, and it remains unknown whether regional changes in lung aeration can anticipate this clinical deterioration. This is particularly relevant because the oxygenation decline signals that ARDS progression has already occurred, leading to a less reversible condition.

The investigators will use and integrate advanced respiratory monitoring tools to quantify these components, including surface electromyography, occlusion maneuvers, and esophageal manometry. Additionally, electrical impedance tomography, recently adapted for pediatric use, will be employed to detect early changes in regional aeration. All of these tools are gold standards for each parameter and allow real-time, bedside measurements without adding invasiveness to usual care.

To test the hypothesis, the investigators will quantify respiratory drive, effort, work of breathing, and regional lung aeration throughout all transitional phases of pediatric ARDS. In the acute phase, drive will be assessed via spectral analysis of surface electromyography, and in intermediate and late phases, via airway occlusion pressure at 100 ms. Esophageal manometry will be used to measure effort (swings of esophageal pressure) and work of breathing (pressure-time product). Changes in regional aeration (overstretching, collapse, and heterogeneity) will be assessed using electrical impedance tomography.

The investigators will define mechanical thresholds and cut-off points for each dyspnea component that predict early ARDS progression and outcomes at each transitional phase. Based on the study results, the investigators envision the future development of algorithms to help guide safer transitions between spontaneous and controlled ventilation, to improve outcomes, and prevent residual morbidity. The interdisciplinary team of clinicians and biomedical engineers will work to customize respiratory care in critically ill children, optimizing ventilatory assistance across disease stages.

研究设计

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

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children younger than 18 years old.
  • Diagnosis of pediatric ARDS, as defined by the 2023 Pediatric Acute Lung Injury Consensus Conference (PALICC2).
  • Consent to participate given by legal guardians.

排除标准

  • Tracheostomy.
  • Neuromuscular disease.
  • Uncorrected congenital heart disease.
  • Contraindication to esophageal catheter (choanal atresia, esophageal issues, recent esophageal surgery, etc.) or EIT (pacemakers, defibrillators, and unstable fractures).
  • Emergency intubation.

研究组 & 干预措施

PARDS/ late phase

Weaning from MV

干预措施: Weaning from mechanical ventilation (Device)

PARDS/acute phase

PARDS patients under noninvasive respiratory support

干预措施: Noninvasive respiratory support (Device)

PARDS/intermediate phase

Transition from controlled to assisted MV

干预措施: Transition from controlled to assisted mechanical ventilation (Device)

结局指标

主要结局

Success or Failure of the Intervention

时间窗: From enrollment to the end of respiratory support at 30 days

Oxygenation decline (20% drop from baseline) or clinical signs of ventilatory overload. The outcome of the intervention will be determined by the attending physician. Measurements derived from the use of advanced respiratory monitoring tools will not be used to define the clinical outcome.

Success or Failure of the Intervention

时间窗: From enrollment to the end of respiratory support, with a maximal follow-up of 30 days.

Oxygenation decline (20% drop from baseline) or clinical signs of ventilatory overload. The outcome of the intervention will be determined by the attending physician. Measurements derived from the use of advanced respiratory monitoring tools will not be used to define the clinical outcome.

次要结局

  • Early changes in regional lung aeration, perfusion, or V/Q mismatch(From enrollment to the end of treatment at 30 days)
  • Ventilator-free days(From enrollment to the end of treatment at 30 days)
  • Early changes in regional lung aeration, perfusion, or ventilation/perfusion mismatch(From enrollment to the end of the respiratory support, with a maximal follow-up of 30 days.)
  • Ventilator-free days(From enrollment to the end of respiratory support, with a maximal follow-up of 30 days.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pablo Cruces

MD; Pediatric Critical Care

Universidad Nacional Andres Bello

研究点 (1)

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