E.W. "Al" Thrasher
Status: Funded - Open
High flow nasal cannula treatment for children with acute hypoxic respiratory failure
Andreas Schibler, MD
BACKGROUND: Acute hypoxic respiratory distress (pneumonia) caused by an infection imposes the greatest health care burden on non-elective hospital admissions in developed countries and is associated with a high mortality figure in under resourced countries leading to 1 million childhood deaths every year. Eight in 1000 infants less than 12 months of age need hospital admission due to acute respiratory infection and represents the greatest number of non-elective intensive care admissions in the USA with a cost over U$ 1.7 billion per year.
GAP: Early intervention decreases the need for invasive respiratory support. The World Health Organization has defined the treatment of respiratory hypoxemia in developed and under resourced countries as one of the research gaps.
HYPOTHESIS: The use of high flow nasal cannula therapy in infants and children with an oxygen requirement is superior to current standard oxygen therapy leading to improved outcomes. High flow therapy reduces the need for intensive care admission, invasive mechanical ventilation and intubation.
METHODS: randomized controlled trial in a tertiary and three metropolitan hospitals comparing HFNC therapy to standard oxygen delivery with enrollment in emergency departments. Infants and children <16 years of age presenting to hospital with acute respiratory failure and hypoxemia can be enrolled and allocated to either high flow or standard oxygen therapy. Primary endpoint is need for escalation of therapy to intensive care and need for non-invasive or invasive ventilation. Sample size: for a 50% reduction in escalation of treatment and allowing subgroup analysis a sample size of 1230 (including 10% attrition rate) is required to achieve a significance level of 0.05 with 80% power.
IMPACT: This project will provide high-grade evidence in relation to the safety, feasibility, cost effectiveness, and impact on outcomes for children with respiratory disease.