ActivePhase 3ACTRN12615001305516

Nasal High Flow therapy for Infants and Children with Acute Hypoxemic Respiratory Failure - Pilot Trial

Feasibility of Nasal High therapy and standard practice for Infants and Children with Acute Respiratory Failure

Sponsor

Lady Cilento Children's Hospital

Enrollment

300 participants

Start Date

Jun 20, 2016

Study Type

Interventional

Conditions

Acute Respiratory Failure

Summary

This study aims to develop a multi-centre trial and to assess which infants and children with acute respiratory failure benefit using High Flow Nasal Cannula Therapy (HFNC). For this purpose we will perform a randomised controlled trial comparing current best practice (standard oxygen delivery via subnasal prongs, facemask, venturi mask) versus HFNC therapy. With the introduction of this simple to use respiratory system in regional and tertiary centres we aim to investigate if HFNC therapy has a lower treatment failure rate in comparison to standard oxygen delivery, and to investigate if there is a reduction in the need for transfer of these patients to a tertiary hospital or admit to an intensive care unit.

Eligibility

Sex: Both males and femalesMax Age: 16 Yearss

Inclusion Criteria3

Children aged 0-16 years of age with the clinical diagnosis of an Acute Hypoxemic Respiratory Failure disease process such as acute lower respiratory tract infection or asthma, or pnuemonia as examples, and an oxygen requirement in room air (SpO2 <92%)
Included are infants with reactive airway disease >12 months and an oxygen requirement in room air (SpO2 <92%). This includes infants >12 months with the diagnosis of bronchiolitis.
Informed consent from parents or guardians

Exclusion Criteria14

Upper airway obstruction
Craniofacial malformations
Critically ill infants requiring immediate higher level of respiratory support i.e. NIV or invasive ventilation, low level of consciousness.
Basal skull fracture
Cyanotic Heart Disease
Home Oxygen therapy
Apnoeas (defined as requiring respiratory support such as NIV or mechanical ventilation)
Upper airway obstruction
Trauma
Cystic Fibrosis
Oncology patients
Palliative Care patients
Previous use of NHF therapy
Child protection case

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Interventions

Nasal High Flow Oxygen Delivery at a weight prescribed flow rate for the duration of oxygen requirement. Initially FiO2 is set at 0.21 and SpO2 observed for 10 minutes. If SpO2 remains less than 92% (hospital threshold dependent) after 10 minutes then FiO2 is increased and titrated to achieve SpO2 greater than or equal to 92%. If patient presents with SpO2 less than 85% then FiO2 is immediately increased to achieve SpO2 equal to or greater than 92%. FiO2 is adjusted to achieve and maintain SpO2 of 92-98% avoiding long periods of hyperoxia with SpO2 of 100%. For any flow rates greater than 25 L/min the flow rates are increased gradually over two minutes at commencement, and observe how the flow rates are tolerated. These alterations are made by the treating physician or nurse in attendance and recorded on the patients respiratory observation chart.