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临床试验/NCT03919331
NCT03919331Unknown不适用

Impact of Current Volume Under High-rate Nasal Oxygen Therapy During Acute Hypoxemic Respiratory Failure de Novo

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Failure of high flow nasal canula (HFNC) at day 28

研究概览

简要总结

De novo acute hypoxemic respiratory failure (AHRF) is associated with high overall mortality, which increases significantly with the use of orotracheal intubation. High flow nasal canula (HFNC) has turned to be the first line non-invasive oxygenation strategy aiming to avoid intubation. One of the main factors worsening lung injury and increasing mortality in invasively ventilated patients is a too high tidal volume (TV) delivered by the ventilator. Consistent data suggest that such an aggravation of respiratory lesions may occur during spontaneous ventilation if TV is too large. This phenomenon is called Patient self-inflicted lung injury (P-SILI). The effect of TV on the outcome of patients with de novo AHRF under HFNC has never been evaluated since TV is not easily accessible in patients under HFNC. Investigators hypothesized that a large TV during HFNC has an impact on the outcome. TV will be measured using chest Electrical Impedance Tomography (EIT). To calibrate the EIT data, i.e. to be able to convert changes in thoracic impedance into TV, thoracic impedance signal, flow and volume will be collected during a 4 cmH2O continuous positive airway pressure (CPAP) test, using a pneumotachograph inserted on the ventilator circuit between the mask and the Y-piece. Such a level of CPAP is supposed to reproduce the majority of the physiological effects of HFNC. Thus, EIT signal can be used to calculate TV during HFNC since it remains reliable even when the positive expiratory pressure changes.

A secondary objective is to quantify a respiratory distress index. This quantification will be recorded by respiratory inductance plethysmography (RIP), obtained using two elastic bands equipped with a sensor sensitive to their stretching, one positioned at the level of the thorax, the other at the level of the abdomen. The stretching changes of the two bands during the respiratory cycle allow evaluating their possible asynchronism by calculating the phase angle Investigators want to be able to evaluate up to 6 predictors of HFNC failure in this research with an effect size of 0.15, α risk of 0.05, and a power of 0.8. A number of 55 participants is required. Investigators plan to include 60 patients due to potential withdrawal of consent and/or unusable data.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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 old
  • HFNC initiated as part of the care
  • Respiratory rate > 25 / minute
  • PaO2/FiO2 ratio < 300 mm Hg
  • PaCO2 < 45 mm Hg
  • Affiliated with a social security system
  • Informed consent signed by the patient, trusted person or family member if the patient is unable to consent

排除标准

  • Acute cardiogenic pulmonary edema
  • Underlying chronic respiratory disease
  • Asthma exacerbation
  • Chronic obstructive pulmonary disease Exacerbation
  • Hemodynamic instability, defined as systolic arterial blood pressure < 90 mm Hg or mean arterial blood pressure < 65 mm Hg or the use of vasopressors
  • Glasgow Coma Score <= 12
  • Contraindication to CPAP (maxillofacial surgery, facial trauma)
  • Refusal of the patient to perform the CPAP test
  • Need for emergency intubation according to the clinician in charge of the patient
  • Patient protected by law
  • Pregnancy or breastfeeding woman

研究组 & 干预措施

Experimental

Experimental

Every adult patient admitted to the medical intensive care unit for de novo acute hypoxemic respiratory failure, and placed under hign flow nasal canula (HFNC). Inclusion and exclusion criterion are listed elsewhere.

干预措施: Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC) (Diagnostic Test)

结局指标

主要结局

Failure of high flow nasal canula (HFNC) at day 28

时间窗: Day 28

Failure of HFNC is defined as death or need for invasive mechanical ventilation

次要结局

  • Tidal volume under high flow nasal canula (HFNC)(Day 0, Day 1 and Day 2)
  • Phase angle computed by respiratory inductance plethysmography (RIP)(Day 0, Day 1 and Day 2)
  • SaO2 under high flow nasal canula (HFNC)(Day 0, Day 1 and Day 2)
  • Regional tidal volume.(Day 0, Day 1 and Day 2)
  • Respiratory rate(Day 0, Day 1 and Day 2)
  • pH under high flow nasal canula (HFNC)(Day 0, Day 1 and Day 2)
  • PaO2 under high flow nasal canula (HFNC)(Day 0, Day 1 and Day 2)
  • PaCO2 under high flow nasal canula (HFNC)(Day 0, Day 1 and Day 2)
  • Mortality(Day 28, Day90)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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