THRIVE in Children at Different Flow Rates

NCT ID: NCT03812354

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2020-03-31

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.

Conditions

Apnea; Ventilation Therapy; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

THRIVE 2L/kg/min

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

THRIVE 4L/kg/min

Intervention Type: OTHER

High-flow nasal cannula therapy with 4L/kg/min with 100% oxygen via OptiFlow by Fisher\&Paykel, Auckland, New Zealand.

Interventions

THRIVE 4L/kg/min

High-flow nasal cannula therapy with 4L/kg/min with 100% oxygen via OptiFlow by Fisher\&Paykel, Auckland, New Zealand.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Optiflow; Optifloe

Eligibility Criteria

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).

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Thomas Riva

Consultant Anaesthesia, MD, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Greif, MD

Role: STUDY_CHAIR

Department of Anesthesia, University Hospital Bern

Locations

Inselspital

Bern, , Switzerland

University Hospital Bern

Bern, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 33351194 (View on PubMed)

Other Identifiers

Riva2018

Identifier Type: -

Identifier Source: org_study_id