跳至主要内容
临床试验/NCT04026217
NCT04026217暂停不适用

Evaluation of Diaphragmatic Function in Hematological Patients With Acute Hypoxemic Respiratory Failure

Azienda Sanitaria-Universitaria Integrata di Udine1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
30
试验地点
1
主要终点
Diaphragm thickening fraction

研究概览

简要总结

Acute hypoxemic respiratory failure due to parenchymal disfunction is one of the main complications of immunocompromised hematological patients. Mechanical ventilation is frequently needed and diaphragm activity has to be assessed not to worsen ventilator-induced lung injury.

详细描述

Acute hypoxemic respiratory failure due to parenchymal disfunction is one of the main complications of immunocompromised hematological patients. In these cohort of patients mechanical ventilation is frequently needed in order to restore oxygenation and normocapnia. Since every positive-pressure ventilation regimen may potentially determine pulmonary complications, due to alteration in pressure and volume lung homeostasis and diaphragm activity, also diaphragm function has to be assessed not to worsen ventilator-induced lung injury (VILI). Main targets of VILI are pulmonary interstitium and diaphragm.

Pulmonary interstitium is frequently involved in different mechanism of injury, that derive both from induced tidal volume and positive end expiratory pressure (PEEP). Indeed, large tidal volumes generated during assisted spontaneous breathing may configure non-protective ventilation regimens and the so called "pendelluft phenomenon", that is the intrinsic flow of air within the lung from nondependent to dependent regions without changes in tidal volume, may affect inadequate PEEP values.

Positive-pressure ventilation may also alter diaphragm activity. Recent data show that diaphragm disfunction, considered as an enhanced or reduced thickening fraction, occurs in about 65% of patients undergoing mechanical ventilation.

Since the potential harm of positive-pressure ventilation, the optimization of mechanical ventilation is pivotal to ensure an adequate time-to-recovery without concurring to the onset of further lung and diaphragmatic injury. Neurally Adjusted Ventilatory Assist (NAVA) is a recent modality of mechanical ventilation that delivers ventilatory assistance according to the respiratory effort of the patient, measured by electrical activity of the diaphragm (EAdi). NAVA works proportionally with EAdi values, ensuring a better neuroventilatory efficiency compared to other mechanical ventilation modes and also reducing patient-ventilator asynchrony. According to these features NAVA protocol may be useful in preserving gas exchanges and diaphragm function both in invasive and non-invasive ventilation.

Therefore the evaluation of basal diaphragm activity, the choice of the device for oxygen support administration and the setting of ventilatory parameters may influence hospital stay and outcome of patients affected by acute hypoxemic respiratory failure.

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

  • Hypoxemic respiratory failure in hematological patients (PaO2 < 70 mmHg or P/F < 150)

排除标准

  • Patients with positive-pressure ventilation regimen of high flow nasal cannula prior to ICU admission
  • Unstable clinical condition (use of vasopressors, acute coronary syndrome...)
  • Refusal of treatment or informed consent
  • Agitation (RASS ≥+2) or lack of collaboration (Kelly Matthay ≥ 5)
  • Multiple organ failure
  • Enrollment in other study protocols

结局指标

主要结局

Diaphragm thickening fraction

时间窗: At ICU admission

Diaphragm thickening fraction measured with echography

次要结局

  • Failure of non-invasive ventilation(From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months)
  • Rate of tracheal intubation(From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months)
  • Duration of positive-pressure ventilation(From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months)
  • Hospital length of stay(From date of in-hospital admission until the date of hospital discharge, assessed up to 36 months)
  • Diaphragm thickening fraction(From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months)
  • In-hospital mortality(From date of in-hospital admission until the date of death from any cause or hospital discharge, assessed up to 36 months)
  • Arterial blood gas analysis(From date of enrollment until the date of death from any cause or ICU discharge, assessed up to 36 months)

研究者

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

Luigi Vetrugno

Luigi Vetrugno, M.D., Anesthesiology and Intensive Care Clinic, Department of Medicine, University of Udine

Azienda Sanitaria-Universitaria Integrata di Udine

研究点 (1)

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