THRIVE in Children at Different Flow Rates

Not Applicable

Completed

• Conditions: Apnea; Ventilation Therapy; Complications
• Interventions: Other: THRIVE 2L/kg/min; Other: THRIVE 4L/kg/min

• Registration Number: NCT03812354
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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.

Study Timeline

• Study Start: 2019-01-15
• Study First Submitted: 2019-01-18
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-23
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-06
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• paediatric patients undergoing elective surgery requiring general anesthesia with intubation at the University Hospital - Inselspital in Bern.
• ASA physical status 1&2
• 10-15kg
• legal guardians providing written informed consent.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
THRIVE 2L/kg/min using OptiFlow	THRIVE 2L/kg/min	High-flow nasal cannula therapy with 2L/kg/min with 100% oxygen via OptiFlow by Fisher\&Paykel, Auckland, New Zealand.
THRIVE 4L/kg/min using OptiFlow	THRIVE 4L/kg/min	After apnea sets in and mask ventilation is successfully established, randomization envelopes are opened and according to group allocation, the following oxygen delivery system is applied. High-flow nasal cannula therapy with 4L/kg/min with 100% oxygen via OptiFlow by Fisher\&Paykel, Auckland, New Zealand.

Primary Outcome Measures

Name	Time	Method
Change of tcCO2 in mmHg/min	10 minutes	mean tcCO2 increase in mmHg/min during apnoea time, measured transcutaneously.

Secondary Outcome Measures

Name	Time	Method
NIRS	10 minutes	changes in brain oxygenation (measured by near infrared spectroscopy (NIRS)) during apnoea time
tcO2 in mmHg/min	10 minutes	Changes in tcO2 in mmHg/min
Electrical impedance tomography	10 minutes	changes in electrical impedance tomography (EIT) to validate ventilatory effect
desaturation from SpO2 100% to 95%	10 minutes	time (in seconds) until desaturation from SpO2 100% to 95%

Trial Locations

Locations (2)

Inselspital; 🇨🇭 Bern, Switzerland

University Hospital Bern; 🇨🇭 Bern, Switzerland