跳至主要内容
临床试验/NCT02979067
NCT02979067已完成不适用

Improvement of Oxygenation During Apnoea by i-THRIVE (Infant Transnasal Humidified Rapid Insufflation Ventilatory Exchange): A Single-centre Prospective Randomized Controlled Trial.

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Time until desaturation from SpO2 100% to 95% measured by pulse oxymetry

研究概览

简要总结

Improvement of oxygenation during apnoea by i-THRIVE Infant Transnasal Humidified Rapid Insufflation Ventilatory Exchange A single-centre prospective randomized controlled trial.

详细描述

High-Flow nasal cannula therapy is the administration of heated, humidified and blended air/oxygen via nasal cannula at rates of at least 2 L/kg bodyweight /min. This high-flow nasal cannula therapy was developed in neonatal intensive care unit for preterm babies with respiratory pauses as an alternative to continuous pressure support (CPAP). Due to its ease of use and safety to apply to a wide range of indication, this oxygen delivery therapy is increasingly gaining interest for providing respiratory support in paediatric and adult patients with respiratory failure in the ICU. High-flow nasal cannula therapy is applied in preterm infant with respiratory distress syndrome, apnoea of prematurity or a respiratory support after extubation. In the adult population the use of HFNCT focuses on hypoxemic respiratory failure and improvement reduction of hypoxemia during intubation in the anesthesia environment. A new application for high-flow nasal cannula therapy in adults is the extension of apnoea time in patients with difficult airways who are undergoing general anesthesia. In this environment a new term for this kind of oxygen therapy was created: THRIVE transnasal humidified rapid-insufflation ventilatory exchange. To distinguish this kind of high-flow nasal cannula therapy in apnoeic patients from the one in the paediatric ICU or ward the investigators use the term i-THRIVE for infant transnasal humidified rapid insufflation ventilation exchange.

Due to the increased oxygen consumption and the reduced functional residual capacity, neonates, infants, and small children have a reduced apnoea tolerance compared to adults. Furthermore infants and small children have a greater closing capacity, which increases the airway collapse under general anesthesia and muscle paralysis. A direct consequence is that hypoxemia is very likely to occur after cessation of spontaneous or assisted ventilation during induction of anesthesia. Apnoea without supplemental oxygen leads to hypoxemia in a 1-year-old infant without preoxygenation within seconds. All paediatric (and adult) patients undergoing general anesthesia have at least a brief period of apnoea during intubation between the time the face-mask is removed from the patient and the tube is placed in the trachea. Therefore, at least short phases of deoxygenation may occur.

However if anesthesia needs to be provided in emergency situations or in the presence of a difficult airway, the rate of complication increases rapidly. In these circumstances methods that reduce desaturation incidents during prolonged difficult intubation are desirable. Due to oxygen toxicity in neonates or small children, prevention of hypoxemia with oxygen concentration below 60% would be favourable in this setting. Despite promising pilot results with high-flow nasal cannula therapy, it is unknown whether this technique is superior to low-flow oxygenation with high concentration and whether it is necessary to apply high-flow nasal cannula therapy with high (80-100%) versus low (30-50%) concentration oxygen.

This study investigates under controlled circumstances the concept of i-THRIVE to prolong the apnoea time without deoxygenation and to improve safety of airway management in paediatric patients. Furthermore, this study enables to quantify the effects of different oxygen concentrations with high-flow nasal cannula therapy and distinguishes it better from conventional low-flow apnoeic oxygenation methods.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Written informed consent
  • Speaking German

排除标准

  • Difficult intubation
  • Oxygen dependency
  • Congenital heart or lung disease
  • BMI >30g/m2
  • High aspiration risk
  • nasal obstruction

结局指标

主要结局

Time until desaturation from SpO2 100% to 95% measured by pulse oxymetry

时间窗: up to ten minutes during intervention

次要结局

  • TcO2mmHg level(study intervention, around 15 minutes)
  • TcCO2mmHg level(study intervention, around 15 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验