NCT03812354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

January 18, 2019

Last Update Submit

August 6, 2020

Conditions

ApneaVentilation Therapy; Complications

Keywords

infantairway managementapneic oxygenation

Outcome Measures

Primary Outcomes (1)

  • Change of tcCO2 in mmHg/min

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

    10 minutes

Secondary Outcomes (4)

  • desaturation from SpO2 100% to 95%

    10 minutes

  • tcO2 in mmHg/min

    10 minutes

  • NIRS

    10 minutes

  • Electrical impedance tomography

    10 minutes

Study Arms (2)

THRIVE 2L/kg/min using OptiFlow

ACTIVE COMPARATOR

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

THRIVE 4L/kg/min using OptiFlow

EXPERIMENTAL

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

Interventions

THRIVE 4L/kg/minOTHER

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

Also known as: Optiflow
THRIVE 4L/kg/min using OptiFlow
THRIVE 2L/kg/minOTHER

High-flow nasal cannula therapy with 2L/kg/min with 100% oxygen via OptiFlow by Fisher\&Paykel, Auckland, New Zealand.

Also known as: Optifloe
THRIVE 2L/kg/min using OptiFlow

Eligibility Criteria

Age1 Year - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Inselspital

Bern, 3010, Switzerland

Location

University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 33351194DERIVED

MeSH Terms

Conditions

Apnea

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Robert Greif, MD

    Department of Anesthesia, University Hospital Bern

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anaesthesia, MD, Principal investigator

Study Record Dates

First Submitted

January 18, 2019

First Posted

January 23, 2019

Study Start

January 15, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

August 7, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)