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临床试验/NCT03812354
NCT03812354已完成不适用

THRIVE (Transnasal Humidified Rapid Insufflation Ventilatory Exchange) in Children at Different Flow Rates

Insel Gruppe AG, University Hospital Bern4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
4
主要终点
Change of tcCO2 in mmHg/min

研究概览

简要总结

This study investigates under controlled circumstances the concept of THRIVE to improve the ventilation and the carbon dioxide elimination, to prolong the apnoea time without deoxygenation and to improve safety of airway management in pediatric patients.

详细描述

Eligible, consented children will be prepared for general anaesthesia in the usual way. After start of anesthesia (="induction"), adequate face-mask ventilation will be established. The sealed envelope for randomisation will then be opened. Standard anesthesia will be continued, either using sevoflurane or propofol (anesthesia depth controlled by Narcotrend, to measure anesthesia depth using processed EEG waves). They will receive additional non-invasive monitoring for this study, such as transcutaneous measurement of tcCO2 and O2, NIRS, and thoracic electrical impedance tomography (EIT, PulmoVista® 500, Draeger, Luebeck, Germany) All patients will receive neuromuscular blockade medication of 2 x ED95 (standard intubation dose) to facilitate airway management and total intravenous anesthesia will be installed (continuous application of i.v. anesthesia medication). Up to two minutes of bag-mask ventilation with 100% oxygen and flow rates of 6-8L/min will be applied until an expired oxygen concentration of >90% is reached, as well as an SpO2 of 100% and an transcutaneous CO2 of 30-40mmHg.

For the study intervention, the bag-mask ventilation will be discontinued, and the child will be left apnoeic (the same happens always during intubation) until the saturation drops to 95%, which is still a low normal value. According randomization, any of the two study intervention s will be applied (THRIVE therapy with 100% O2 2l/kg/min, THRIVE therapy with 100% O2 4l/kg/min, all via nasal cannulas) while simultaneously guaranteeing an open airway by using Esmarch's procedure (jaw thrust) and an oral airway (Guedel tube). ECG, pulse-oximetry, blood pressure, Narcotrend, NIRS, thoracic EIT, PtcO2, PtcCO2 will be measured continuously over the study period. The time until desaturation from SpO2 100% to SpO2 95% will be also measured. A chest ultrasound at the end of the intervention will prove that no pneumothorax developed during the procedure. The study intervention will end at the time the saturation reaches SpO2 95% or when any other break-up criteria are reached. Bag mask ventilation will then be re-applied until SpO2 reaches again 100% and the patient will be treated according to the attending anaesthesiologist to ultimately establish a patent airway. Break-up criteria during apnoea are: SpO2 below 95%, transcutaneous CO2 above 70 mmHg, or time of apnoea >10 minutes. Drop of NIRS > 30% from baseline. A postmedication interview will be performed before PACU discharge.

研究设计

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

入排标准

年龄范围
1 Year 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • paediatric patients undergoing elective surgery requiring general anesthesia with intubation at the University Hospital - Inselspital in Bern.
  • ASA physical status 1&2
  • legal guardians providing written informed consent.

排除标准

  • known or suspected difficult intubation
  • oxygen dependency
  • congenital heart or lung disease
  • obesity BMI>20kg/m2
  • high aspiration risk (requiring rapid sequence induction intubation).

结局指标

主要结局

Change of tcCO2 in mmHg/min

时间窗: 10 minutes

mean tcCO2 increase in mmHg/min during apnoea time, measured transcutaneously.

次要结局

  • NIRS(10 minutes)
  • tcO2 in mmHg/min(10 minutes)
  • Electrical impedance tomography(10 minutes)
  • desaturation from SpO2 100% to 95%(10 minutes)

研究者

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

Thomas Riva

Consultant Anaesthesia, MD, Principal investigator

Insel Gruppe AG, University Hospital Bern

研究点 (4)

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