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临床试验/NCT05566652
NCT05566652招募中不适用

Neural Pressure Support for Low Pulmonary Compliance

Policlinico Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10
试验地点
1
主要终点
Work Of Breathing (WOB)

研究概览

简要总结

With this interventional prospective study, we aim at comparing the effectiveness of Neural Pressure Support (NPS) in reducing respiratory work and patient-ventilator asynchronies as compared with standard Pressure Support Ventilation (PSV), in a cohort of patients with Acute Respiratory Failure (ARF) and low respiratory system compliance.

详细描述

Acute respiratory failure (ARF) is a critical condition caused by impaired function of the lungs.1,2 The cornerstone of ARF management is invasive mechanical ventilation (IMV).3,4 Unfortunately, despite lifesaving, IMV is associated with several side effects (e.g., ventilator-associated pneumonia, ventilator associate induced lung injury, diaphragmatic dysfunction), and thus liberation from invasive mechanical ventilation is an everyday effort for critical care physicians.5

Pressure support ventilation (PSV) is one of the most widely used mechanical ventilation modes for liberation from IMV.6 PSV is a partial ventilatory mode: the ventilator and the patient co-operate to generate the inspiratory and expiratory pressures, flows, and volumes. During conventional PSV, the initiation of the breath is triggered by a reduction in expiratory pressure or a drop in expiratory flow.7 The termination of the breath occurs when the inspiratory flow falls to a predetermined fraction of the peak inspiratory flow.8

The main goal of mechanical ventilation is to help restore gas exchange and reduce the work of breathing (WOB) by assisting respiratory muscle activity.9 Knowing the determinants of WOB is essential for the effective use of mechanical ventilation and also to assess patient readiness for weaning. To reduce WOB, PSV needs to be synchronous and smooth interaction should happen between the ventilator and the respiratory muscles.10

Ideally, the ventilator trigger and cycling should coincide with the beginning and end of the patient's inspiratory effort.11 However, patient-ventilator asynchrony is common during PSV,12,13 thereby contributing to an increased work of breathing and an increased duration of mechanical ventilation.14

An important objective of assisted or patient-triggered mechanical ventilation is to avoid ventilator-induced diaphragmatic dysfunction by allowing the patient to generate spontaneous efforts.15 A second objective is to reduce the patient's work of breathing by delivering a sufficient level of ventilatory support.16 Finally, intuition suggests that a good match between patient respiratory efforts and ventilator breaths optimizes patient comfort and reduces work of breathing.17 Patient-ventilator asynchrony can be defined as a mismatch between the patient and ventilator inspiratory and expiratory times.18 Although inspiratory and expiratory delays are almost inevitable with most ventilatory modes, several patterns of major asynchrony exist and can be easily detected by clinicians.14

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

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

  • Age > 18 years
  • Admission to Intensive Care Unit (ICU) for ARF
  • Low compliance of the respiratory system (Crs ≤ 30 ml/cmH2O)
  • Written informed consent obtained

排除标准

  • Contraindication to nasogastric tube insertion (gastroesophageal surgery in the previous 3 months, gastroesophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma)
  • Increased risk of bleeding with nasogastric tube insertion, due to severe coagulation disorders and severe thrombocytopenia ( i.e., International Normalized Ratio (INR) > 2 and platelets count < 70.000/mm3)
  • Severe hemodynamic instability (noradrenaline > 0.3 μg/kg/min and/or use of vasopressin)
  • Failure to obtain a stable EAdi signal
  • Central nervous system or neuromuscular disorders
  • Moribund status

研究组 & 干预措施

NPS

Experimental

To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing Neural Pressure Support Ventilation.

干预措施: Neural Pressure Support (Device)

NPS

Experimental

To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing Neural Pressure Support Ventilation.

干预措施: Pressure Support Ventilation (Drug)

PSV

Sham Comparator

To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing Pressure Support Ventilation.

干预措施: Neural Pressure Support (Device)

PSV

Sham Comparator

To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing Pressure Support Ventilation.

干预措施: Pressure Support Ventilation (Drug)

结局指标

主要结局

Work Of Breathing (WOB)

时间窗: 30 minutes ventilatory traces recording

We hypothesize that Neural Pressure Support (NPS) is able to improve the patient-ventilator interaction, thus reducing significantly the patient's work of breathing (WOB). WOB will be evaluated by the off-line analysis of the esophageal pressure waveform.

次要结局

  • Asynchronies(30 minutes ventilatory traces recording)

研究者

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

Giacomo Grasselli

Full Professor

Policlinico Hospital

研究点 (1)

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