跳至主要内容
临床试验/NCT07686315
NCT07686315招募中不适用

Advanced Respiratory Monitoring for Safer Mechanical Ventilation in Patients Without Respiratory Failure

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年6月30日最近更新:
适应症

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
1
主要终点
Incidence of Acute Respiratory Distress Syndrome (ARDS)

研究概览

简要总结

Patients admitted to the intensive care unit (ICU) and mechanically ventilated for reasons other than acute respiratory failure, such as coma, trauma, or sepsis, are at risk of developing acute respiratory distress syndrome (ARDS), which increases the duration of mechanical ventilation, mortality, and functional dependence at discharge.

详细描述

Patients admitted to the intensive care unit (ICU) and mechanically ventilated for reasons other than acute respiratory failure, such as coma, trauma, or sepsis, are at risk of developing acute respiratory distress syndrome (ARDS), which increases the duration of mechanical ventilation, mortality, and functional dependence at discharge. Low tidal volume mechanical ventilation is recommended for these patients to prevent ARDS, but few other modifiable risk factors are known. Advanced respiratory monitoring, which includes continuous recording of airway and esophageal pressure, inspiratory and expiratory flow, and the distribution of ventilation within the lungs, has been used in patients with ARDS to personalize ventilation parameters, prevent ventilator-induced lung injury (VILI), and improve outcomes. It is unknown whether the use of these same monitoring techniques in patients without respiratory failure at the time of ICU admission can prevent the development of ARDS.

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

入选标准

  • Study Population Eligibility Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No
  • Inclusion Criteria:
  • Adult patients +18 years. Undergoing invasive mechanical ventilation for reasons other than acute respiratory failure (such as coma, trauma, or sepsis).
  • Initiation of monitoring within 24 hours of oro-tracheal intubation.

排除标准

  • Evidence of pneumothorax, pneumomediastinum, or subcutaneous emphysema. Pregnancy. Absolute contraindications to nasogastric tube placement. Absolute contraindications to electrical impedance tomography (EIT) monitoring.

结局指标

主要结局

Incidence of Acute Respiratory Distress Syndrome (ARDS)

时间窗: Within the first 7 days of Intensive Care Unit (ICU) admission.

Association between ARDS development and advanced respiratory monitoring parameters derived from: Airway pressure/flow analysis: tidal volume/kg of ideal body weight, respiratory rate, plateau pressure, driving pressure, respiratory system compliance, and stress index. Esophageal pressure analysis: lung compliance, transpulmonary plateau pressure, transpulmonary driving pressure, and chest wall compliance. Electrical impedance tomography (EIT): regional compliance and tidal volume distribution homogeneity.

次要结局

未报告次要终点

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele Tedeschi

Medical Doctor

Istituto Clinico Humanitas

研究点 (1)

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