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临床试验/NCT03138148
NCT03138148已完成不适用

Evaluation of the Patient-ventilator Asynchrony During Mechanical Ventilation for Pediatric Acute Respiratory Failure

St. Justine's Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Difference in ventilator free days

研究概览

简要总结

The synchronization between the patient and the ventilator is an essential objective during mechanical ventilation (MV). Maintaining the patient's respiratory activity during MV reduces ventilation pressures, improves oxygenation, and decreases sedation. In order to do this, the inspiratory or expiratory effort of the patient must be detected by the respirator' sensor systems, so that the assistance delivered by the respirator is coordinated with the patient's respiratory cycles. The usual systems do not actually detect the beginning of the effort but its result: variation in flow rate or pressure at the respirator circuit, which depends on the patient's respiratory mechanics and sensitivity of the sensor. This detection is currently imperfect, which generates asynchrony between the patient's needs and the assistance of the respirator. The asynchrony comprises the periods of delay between the beginning of the inspiration (or expiration) and the response of the respirator, but also of the unsuitable cycles: inspiratory efforts of the patient not detected by the respirator, or inversely triggering assistance in the absence of inspiration by the patient (self-initiation), or delivery of 2 cycles of assistance for a single inspiration (double triggering).

Asynchrony is a risk factor for prolonged mechanical ventilation in adults. Adult studies have shown that patient-ventilator asynchrony is common during MV, and is associated with prolonged MV duration. An association with length of stay in intensive care and in hospital was also observed. In children, patient-ventilator synchronization is more difficult to achieve than in adults due to a higher respiratory rate and smaller current volumes. The impact of patient-ventilator asynchrony on evolution has not been studied in pediatrics.

Patient-ventilator synchronization could be improved by the development of new ventilatory modes. The new NAVA (neurally adjusted ventilatory assist) ventilation mode detects the patient's breathing efforts earlier by monitoring the electrical activity of the diaphragm through the esophagus. This new mode seems to improve synchronization in children. NAVA ventilation may therefore be a step forward, but its clinical benefits remain to be seen.

The objective of this study is to evaluate the impact of patient-ventilator asynchrony on the duration of mechanical ventilation in children with acute 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
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Mechanical ventilation planned for more than 24h according to the physician in charge;
  • Presence of a spontaneous respiratory activity (defined by the presence of respiratory cycles activated by the patient);
  • Parental consent obtained with the parents or with the legal representative.

排除标准

  • pathologies for which a long and difficult weaning of the mechanical ventilation is expected: chronic respiratory failure with history of ventilation superior to one month, severe neurological or muscular pathology;
  • Patients with a tracheotomy;
  • Patients receiving a treatment by curare;
  • Contraindication of recording of the diaphragmatic activity by oesophageal way, in particular recent oesophageal surgery, oesophageal stenosis, suspicion of diaphragmatic paralysis, severe coagulation disorder;
  • Patients to whom a death seems imminent;
  • Patients for whom a limitation of the care was considered.

结局指标

主要结局

Difference in ventilator free days

时间窗: 28 days

Difference in ventilator free days at Day 28th between the two patient groups (high versus moderate asynchrony)

次要结局

  • The impact of asynchrony on Comfort scale(at inclusion)
  • Intensive care unit length of stay(28 days)
  • Mortality in pediatric intensive care unit(28 days)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Guillaume Emeriaud

Principal Investigator, Intensivist, Clinical Associate Professor

St. Justine's Hospital

研究点 (1)

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