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High-Flow Humidified Oxygen as an Early Intervention in Children With Acute Severe Asthma: Protocol for a Feasibility
Hector Rojas-Anaya1,2, Akshat Kapur3, Graham Roberts4,5
1University Hospitals Sussex National Health Service Foundation Trust, Brighton, United Kingdom.
Insights
This feasibility study explored early high-flow humidified oxygen (HiFlo) therapy for acute severe asthma (ASA) in children. Despite pandemic disruptions, recruitment met targets, paving the way for a definitive trial on this promising treatment.
Area of Science:
- Pediatric Respiratory Medicine
- Clinical Trial Design
- Emergency Medicine
Background:
- Acute severe asthma (ASA) is a common pediatric emergency requiring effective treatments.
- Current therapies for non-responsive ASA have limitations, necessitating novel approaches.
- High-flow humidified oxygen (HiFlo) is increasingly used in ASA, but evidence is limited.
Purpose of the Study:
- To assess the feasibility and safety of a full randomized controlled trial (RCT) for early HiFlo therapy in pediatric ASA.
- To evaluate the practicality of recruitment using deferred consent.
- To determine appropriate outcome measures and sample sizes for a definitive RCT.
Main Methods:
- A feasibility randomized controlled trial (RCT) was conducted with deferred consent.
- Children aged 2-11 years with acute severe wheeze unresponsive to standard therapy were randomized.
- Outcomes included treatment escalation rates, time to discharge criteria, and patient/parent experiences.
Main Results:
- The trial successfully recruited to target despite significant delays due to the COVID-19 pandemic.
- Recruitment spanned from February 2020, with a 15-month pause, concluding in June 2023.
- Data analysis is ongoing to inform a larger definitive trial.
Conclusions:
- The feasibility RCT demonstrated successful recruitment for early HiFlo therapy in pediatric ASA.
- The study provides essential data for planning a large-scale, powered RCT.
- Further analysis will clarify HiFlo's role in improving outcomes for children with severe asthma.
Background:
Acute severe asthma (ASA) is a leading cause of hospital attendance in children. Standard first-line therapy consists of high-dose inhaled bronchodilators plus oral corticosteroids. Treatment for children who fail to respond to first-line therapy is problematic: the use of intravenous agents is inconsistent, and side effects are frequent. High-flow humidified oxygen (HiFlo) is widely used in respiratory conditions and is increasingly being used in ASA, but with little evidence for its effectiveness. A well-designed, adequately powered randomized controlled trial (RCT) of HiFlo therapy in ASA is urgently needed, and feasibility data are required to plan such an RCT. In this study, we describe the protocol for a feasibility study designed to fill this knowledge gap.
Objective:
This study aims to establish whether a full RCT of early HiFlo therapy in children with ASA can be conducted successfully and safely, to establish whether recruitment using deferred consent is practicable, and to define appropriate outcome measures and sample sizes for a definitive RCT. The underlying hypothesis is that early HiFlo therapy in ASA will reduce the need for more invasive treatments, allow faster recovery and discharge from hospital, and in both these ways reduce distress to children and their families.
Methods:
We conducted a feasibility RCT with deferred consent to assess the use of early HiFlo therapy in children aged 2 to 11 years with acute severe wheeze not responding to burst therapy (ie, high-dose inhaled salbutamol with or without ipratropium). Children with a Preschool Respiratory Assessment Measure score ≥5 after burst therapy were randomized to commence HiFlo therapy or follow standard care. The candidate primary outcomes assessed were treatment failure requiring escalation and time to meet hospital discharge criteria. Patient and parent experiences were also assessed using questionnaires and telephone interviews.
Results:
The trial was opened to recruitment in February 2020 but was paused for 15 months owing to the COVID-19 pandemic. The trial was reopened at the lead site in July 2021 and opened at the other 3 sites from August to December 2022. Recruitment was completed in June 2023.
Conclusions:
This feasibility RCT of early HiFlo therapy in children with ASA recruited to the target despite major disturbances owing to the COVID-19 pandemic. The data are currently being analyzed and will be published separately.
Trial Registration:
International Standard Randomised Controlled Trial Number Registry ISRCTN78297040; https://www.isrctn.com/ISRCTN78297040.
International Registered Report Identifier (Irrid):
DERR1-10.2196/54081.
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