Assessing the Physiological Impact and Safety of Continuous High-Frequency Oscillatory Ventilation in Critically Ill Patients Under Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- EELV
研究概览
简要总结
Mechanical ventilation is an important treatment modality for intensive care unit (ICU) patients, but it also brings a series of problems such as ventilator-associated pneumonia, ventilator-induced lung injury, and atelectasis. Continuous High-Frequency Oscillation (CHFO )is often considered to have a protective effect on the lungs. CHFO provides effective gas exchange at supraphysiological frequencies while minimizing pressure fluctuations, producing tidal volumes smaller than dead space and adjusting around a continuously expanding pressure to optimize end-expiratory lung volume (EELV) by achieving and maintaining lung recruitment. However, the physiological effects and safety of CHFO in critically ill patients on mechanical ventilation lack relevant research. The objective of this research is to assess the feasibility, safety, and efficacy of CHFO in a population of mechanically ventilated critically ill patients.
详细描述
This is an interventional study evaluating the beneficial impact of CHFO of patients with mechanical ventilation on pathophysiological parameters.
This therapeutic study aims to treat patients using CHFO machine (MetaNeb system). The study consists of comparing pulmonary pathophysiological parameters before and after the treatment of CHFO in patients with invasive mechanical ventilation.
The primary outcome is the difference between the end-expiratory lung volume (EELV) and chest electrical impedance tomography (EIT) measured at the end of CHFO (10 min) and the basal value measured at the beginning of the protocol.
The minimum number of subjects to enroll in this study is 30 patients with invasive mechanical ventilation. Intermediate analyses are planned every 5 patients in order to reevaluate the needed number of patients.
The basal value at the beginning of the protocol, collection of ventilatory parameters on the ventilator, collection of arterial blood gas analyses and measurement of heart rate, and blood pressure. In the middle of treatment, collection of arterial blood gas analyses and measurement of heart rate, and blood pressure. At the end of the treatment, collection of ventilatory parameters on the ventilator, collection of arterial blood gas analyses and measurement of heart rate, and blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Analysis of data will be conducted by a statistician not involved in interventions at bedside
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 and younger than 90 years;
- •Admitted to the ICU after October 15, 2024, who are intubated and expected to be unable to be extubated within 48 hours due to ARDS, or have atelectasis, or have VAP.
- •Signed informed consent for MetaNeb treatment.
排除标准
- •Refusal to participate in the proposed study.
- •Age < 20 years;
- •Pregnancy;
- •Significant hemodynamic instability defined as an increase of more than 20% in catecholamine doses in the last hour, despite optimization of blood volume, for a target mean blood pressure between 65 and 75 mmHg.
- •Participation in another trial within 30 days prior to meeting eligibility criteria;
- •Severe chronic respiratory disease requiring long-term oxygen therapy or home mechanical ventilation;
- •Pneumothorax;
- •Expected duration of mechanical ventilation < 48 hours
- •Decision to refuse life-sustaining treatment.
结局指标
主要结局
EELV
时间窗: Baseline, and at the end of intervention (30th minute)
EELV was measured utilizing the nitrogen washout-washin technique (E-sCOVX module sensor, GE Healthcare, Madison, WI, USA). The infusion of intravenous anesthetic agents and rocuronium bromide was administered to establish controlled mechanical ventilation during EELV measurement. Consistency in ventilator parameters was maintained throughout the EELV monitoring including follow-up measurements. Measurements will be taken at two time points: (1) Within 30 minutes before the start of CHFO and (2) within 30 minutes after its completion.
EIT
时间窗: Baseline, and at the end of intervention (30th minute)
In EIT monitoring, a 16-electrode belt was placed around the chest to record signals. Measurements will be taken at two time points: (1) Within 30 minutes before the start of CHFO and (2) within 30 minutes after its completion.
次要结局
- Central venous pressure before and after the CHOF treatment(Baseline, and at the end of the intervention (30 minutes post-intervention))
- PaO2/FiO2 ratio before and after the CHOF treatment(Baseline, and at the end of the intervention (30 minutes post-intervention))
- Plateau pressure(Baseline, and at the end of the intervention (30 minutes post-intervention))
- Mean arterial pressure(Baseline, during intervention, and at the end of intervention (30th minute))
- Adverse events(Baseline, during intervention, and at the end of intervention (30th minute))