RESUMEN
Objective: To compare the effectiveness of early high-flow nasal cannula (HFNC) and low-flow oxygen support (LFOS) in children under 5 years with acute hypoxemic respiratory failure (AHRF) due to severe community-acquired pneumonia in low-middle-income countries. Methods: An open-label randomized clinical trial enrolled children aged 2-59 months with AHRF due to severe community-acquired pneumonia and randomized into HFNC and LFOS. In the LFOS group, the patient received cold wall oxygen humidified by bubbling through sterile water administered through simple nasal prongs at a fixed flow rate of 2 L/min. In the HFNC group, the patient received humidified, heated (37 °C), high-flow oxygen at a flow rate assigned based on weight range, with a titratable oxygen fraction. The primary outcome was treatment failure in 72 h (escalating the respiratory support method using any modality other than primary intervention). Results: Data was analyzed intention-to-treat (HFNC = 124; LFOS = 120). Median (IQR) age was 12 (6-20) and 11 (6-27) months, respectively. Treatment failure occurred in a significantly lower proportion in the HFNC group (7.3%, n = 9/124) as compared to the LFOS group (20%, n = 24/120) (relative risk = 0.36, 95% CI 0.18 to 0.75; p = 0.004; adjusted hazard ratio 0.34, 95% CI 0.16 to 0.73; p = 0.006). The intubation rate was significantly lower in the HFNC group (7.3%, n = 9/124 vs. 16.7%, n = 20/120; relative risk = 0.44, 95% CI 0.21 to 0.92, p = 0.023). There were no significant differences noted in other secondary outcomes. No mortality occurred. Conclusion: High-flow nasal cannula oxygen therapy used as early respiratory support in children under 5 years with acute hypoxemic respiratory failure due to severe community-acquired pneumonia was associated with significantly lower treatment failure compared with standard low-flow oxygen support. Trial registration: CTRI/2016/04/006788. Registered 01 April 2016, https://ctri.nic.in/Clinicaltrials/advsearch.php. Supplementary Information: The online version contains supplementary material available at 10.1007/s44253-024-00031-8.
RESUMEN
OBJECTIVES: To compare high-flow nasal cannula (HFNC) versus nasal prong bubble continuous positive airway pressure (b-CPAP) in children with moderate to severe acute bronchiolitis. DESIGN: A randomized controlled trial was carried out from August 2019 to February 2022. (Clinical Trials Registry of India number CTRI/2019/07/020402). SETTING: Pediatric emergency ward and ICU within a tertiary care center in India. PATIENTS: Children 1-23 months old with moderate to severe acute bronchiolitis. INTERVENTION: Comparison of HFNC with b-CPAP, using a primary outcome of treatment failure within 24 hours of randomization, as defined by any of: 1) a 1-point increase in modified Wood's clinical asthma score (m-WCAS) above baseline, 2) a rise in respiratory rate (RR) greater than 10 per minute from baseline, and 3) escalation in respiratory support. The secondary outcomes were success rate after crossover, if any, need for mechanical ventilation (invasive/noninvasive), local skin lesions, length of hospital stay, and complications. RESULTS: In 118 children analyzed by intention-to-treat, HFNC ( n = 59) versus b-CPAP ( n = 59) was associated with a lower failure rate (23.7% vs. 42.4%; relative risk [95% CI], RR 0.56 [95% CI, 0.32-0.97], p = 0.031). The Cox proportion model confirmed a lower hazard of treatment failure in the HFNC group (adjusted hazard ratio 0.48 [95% CI, 0.25-0.94], p = 0.032). No crossover was noted. A lower proportion escalated to noninvasive ventilation in the HFNC group (15.3%) versus the b-CPAP group (15.3% vs. 39% [RR 0.39 (95% CI, 0.20-0.77)], p = 0.004). The HFNC group had a longer median (interquartile range) duration of oxygen therapy (4 [3-6] vs. 3 [3-5] d; p = 0.012) and hospital stay (6 [5-8.5] vs. 5 [4-7] d, p = 0.021). No significant difference was noted in other secondary outcomes. CONCLUSION: In children aged one to 23 months with moderate to severe acute bronchiolitis, the use of HFNC therapy as opposed to b-CPAP for early respiratory support is associated with a lower failure rate and, secondarily, a lower risk of escalation to mechanical ventilation.
