Fellow: Tiranun Rungvivatjarus, Rady Children’s Hospital, University of California – San Diego
Article: Donna Franklin, B.N., M.B.A., Franz E. Babl, M.D., M.P.H., et al. A Randomized Trial of High-Flow Oxygen therapy in Infants with Bronchiolitis. N Engl J Med 2018; 378:1121-31
Summary: This is a multicenter, randomized controlled trial in Australia and New Zealand that compared the use of high-flow oxygen therapy (HFNC) to standard oxygen therapy in infants < 12 months old. The study was conducted across 17 tertiary and regional hospitals and included 1472 patients. The study’s primary outcome was escalation of care due to treatment failure (defined as meeting at least 3 of 4 clinical criteria: persistent tachycardia, tachypnea, hypoxemia, and medical review triggered by a hospital early-warning tool). The study design allows for subjects in standard therapy group to receive rescue HFNC if their condition met criteria for treatment failure. Treatment failure with escalation of care occurred in 12% in HFNC versus 23% in standard therapy group. Among those who failed the standard-therapy, 61% of those responded to HFNC. This means that a total of 9% of standard therapy patients went to the ICU compared to 12% in the HFNC. There was no significant difference between the 2 groups in duration of hospital stay, duration of stay in ICU, or duration of oxygen therapy.
Key strengths of the article: Randomization was performed across multiple institutions and countries. The study was well powered for primary and secondary outcomes. Since therapy cannot be masked to families and providers, pre-specified clinical criteria for escalation of care were created to minimize bias. Analysis was done not only on the overall trial cohort, but also again on infants who met the actual treatment failure criteria with similar results, giving further support to the study’s overall findings.
Key Limitation: Neither the families nor the medical providers were blinded. Inclusion of patients who need oxygen to keep goal sat between 94-98% (at 11 out of 17 hospitals) may not represent the majority of patients in the United States.
Major takeaway: This article supports the safety of HFNC in moderate bronchiolitis on the acute care pediatric ward in infants < 12 months old. The study concludes that there was lower rate of treatment failure when HFNC was used early during the hospital admission than when standard oxygen therapy was used. However, transfer rate to ICU between HFNC group and standard therapy group (when rescue HFNC group was included) were the same, demonstrating support for early standard therapy with HFNC as a rescue option as well.
How this article impact our practice: This article supports the safety of HFNC in moderate bronchiolitis on the acute care pediatric ward and its role as a rescue therapy when standard therapy fails. For those hospitals that do not have access to HFNC on the acute care ward, this article suggests that its use is safe and can be effective at preventing PICU transfer. The weaning protocol and maximum flow rate in this study are very different from institutions around the US, which brings up discussion of how to best wean patient off oxygen therapy and additional future study is needed.
Article: Donna Franklin, B.N., M.B.A., Franz E. Babl, M.D., M.P.H., et al. A Randomized Trial of High-Flow Oxygen therapy in Infants with Bronchiolitis. N Engl J Med 2018; 378:1121-31
Summary: This is a multicenter, randomized controlled trial in Australia and New Zealand that compared the use of high-flow oxygen therapy (HFNC) to standard oxygen therapy in infants < 12 months old. The study was conducted across 17 tertiary and regional hospitals and included 1472 patients. The study’s primary outcome was escalation of care due to treatment failure (defined as meeting at least 3 of 4 clinical criteria: persistent tachycardia, tachypnea, hypoxemia, and medical review triggered by a hospital early-warning tool). The study design allows for subjects in standard therapy group to receive rescue HFNC if their condition met criteria for treatment failure. Treatment failure with escalation of care occurred in 12% in HFNC versus 23% in standard therapy group. Among those who failed the standard-therapy, 61% of those responded to HFNC. This means that a total of 9% of standard therapy patients went to the ICU compared to 12% in the HFNC. There was no significant difference between the 2 groups in duration of hospital stay, duration of stay in ICU, or duration of oxygen therapy.
Key strengths of the article: Randomization was performed across multiple institutions and countries. The study was well powered for primary and secondary outcomes. Since therapy cannot be masked to families and providers, pre-specified clinical criteria for escalation of care were created to minimize bias. Analysis was done not only on the overall trial cohort, but also again on infants who met the actual treatment failure criteria with similar results, giving further support to the study’s overall findings.
Key Limitation: Neither the families nor the medical providers were blinded. Inclusion of patients who need oxygen to keep goal sat between 94-98% (at 11 out of 17 hospitals) may not represent the majority of patients in the United States.
Major takeaway: This article supports the safety of HFNC in moderate bronchiolitis on the acute care pediatric ward in infants < 12 months old. The study concludes that there was lower rate of treatment failure when HFNC was used early during the hospital admission than when standard oxygen therapy was used. However, transfer rate to ICU between HFNC group and standard therapy group (when rescue HFNC group was included) were the same, demonstrating support for early standard therapy with HFNC as a rescue option as well.
How this article impact our practice: This article supports the safety of HFNC in moderate bronchiolitis on the acute care pediatric ward and its role as a rescue therapy when standard therapy fails. For those hospitals that do not have access to HFNC on the acute care ward, this article suggests that its use is safe and can be effective at preventing PICU transfer. The weaning protocol and maximum flow rate in this study are very different from institutions around the US, which brings up discussion of how to best wean patient off oxygen therapy and additional future study is needed.