THRIVE in Children at Different Flow Rates
Condition: Apnea; Ventilation Therapy; Complications
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): THRIVE 4L/kg/min; THRIVE 2L/kg/min
Intervention type(s): Other; Other
Intervention description(s): High-flow nasal cannula therapy with 4L/kg/min with 100% oxygen via OptiFlow by Fisher&Paykel, Auckland, New Zealand.; High-flow nasal cannula therapy with 2L/kg/min with 100% oxygen via OptiFlow by Fisher&Paykel, Auckland, New Zealand.
Other intervention name(s): Optiflow; Optifloe
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: infant; airway management; apneic oxygenation