THRIVE in Children at Different Flow Rates

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

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.

Study Overview

• Status: Completed
• Conditions: Apnea; Ventilation Therapy; Complications
• Intervention / Treatment: Other: THRIVE 2L/kg/min; Other: THRIVE 4L/kg/min

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital Bern
  • Bern, Switzerland, 3010
    • Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: THRIVE 2L/kg/min using OptiFlow; High-flow nasal cannula therapy with 2L/kg/min with 100% oxygen via OptiFlow by Fisher&Paykel, Auckland, New Zealand.	Other: THRIVE 2L/kg/min; High-flow nasal cannula therapy with 2L/kg/min with 100% oxygen via OptiFlow by Fisher&Paykel, Auckland, New Zealand.; Other Names: Optifloe
Experimental: THRIVE 4L/kg/min using OptiFlow; 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.	Other: THRIVE 4L/kg/min; High-flow nasal cannula therapy with 4L/kg/min with 100% oxygen via OptiFlow by Fisher&Paykel, Auckland, New Zealand.; Other Names: Optiflow

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of tcCO2 in mmHg/min	mean tcCO2 increase in mmHg/min during apnoea time, measured transcutaneously.	10 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Study Chair: Robert Greif, MD, Department of Anesthesia, University Hospital Bern

Publications and helpful links

General Publications

• Riva T, Preel N, Theiler L, Greif R, Butikofer L, Ulmer F, Seiler S, Nabecker S. Evaluating the ventilatory effect of transnasal humidified rapid insufflation ventilatory exchange in apnoeic small children with two different oxygen flow rates: a randomised controlled trial. Anaesthesia. 2021 Jul;76(7):924-932. doi: 10.1111/anae.15335. Epub 2020 Dec 22.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: infant; airway management; apneic oxygenation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: Riva2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No