DOI: 10.5061/dryad.vq83bk41k
title: Comparative analysis of predictors of failure for high-flow nasal cannula in bronchiolitis

description: Objective: To assess a comparative analysis of the ROX index,
 Wood-Downes-Ferrés score (WDF), p-ROXI, and the SpO2/FiO2 ratio as
 predictors of high-flow nasal cannula (HFNC) failure in children
 hospitalized for bronchiolitis. Methods: Data were extracted from
 the clinical trial “Comparison between HFNC and NIV in children with acute
 respiratory failure caused by bronchiolitis” conducted at a tertiary
 Brazilian hospital (Emergency Department and PICU). The inclusion criteria
 were children under 2 years of age admitted for bronchiolitis who
 developed mild to moderate respiratory distress and were eligible for HFNC
 therapy. Performance was determined by ROC and AUC metrics to define the
 best sensitivity and specificity for each variable. Children were
 evaluated at 0 h, 2 h, 6 h, 12 h, 24 h, 48 h, 72 h and 96 h after HFNC
 therapy initiation. Results: A total of 126 patients were
 recruited for this analysis. The median age was 3 months. Ninety-one
 percent of the patients had an identified viral agent, with RSV being the
 most common (65%). Twenty-three percent (29/126) of patients experienced
 failed HFNC therapy and required mechanical ventilation. The best cutoff
 points at 12 hours were 4.5 for WDF (AUC=0.83, 0.74-0.92), 8.8 for ROX
 (AUC=0.7, 0.54-0.84), 1.45 for p-ROXI (AUC=0.56, 0.38-0-74), and 269 for
 SpO2/FiO2 (AUC=0.64, 0.48-0.74). The scores and indices were also
 correlated with the PICU and hospital LOS. Conclusions: The ROX index and
 WDF were the most accurate scores for assessing HFNC failure considering
 12-hour cutoff points. Trial registration number: U1111-1262-1740;
 RBR-104z966s. Date of registration: 03/01/2023.
description: The following data were extracted from the clinical trial titled
 “Comparison between high-flow nasal cannula and noninvasive ventilation
 (NIV) in children with acute respiratory failure caused by bronchiolitis”.
 The primary analysis is under structuring for publication. In the present
 study, patients with a diagnosis of mild to moderate acute respiratory
 failure due to bronchiolitis were randomized into two groups according to
 sealed envelopes (HFNC or NIV). Those who experienced therapy failure were
 intubated. In an interim analysis, the failure rate was 32% (17 of the 52
 randomized patients). Therefore, we estimated that a sample of at least 87
 patients would be representative of this population for the current study,
 with a margin of error of 10% and a 95% confidence interval. This study
 was approved by the Institutional Review Board (IRB) of the hospital
 (Hospital Municipal Infantil Menino Jesus Research Ethics Committee;
 approval number 39509820.0.0000.5639, 11/24/2020; trial registration
 number: U1111-1262-1740; RBR-104z966s, 03/01/2023). Despite clinical trial
 submission had been occurred before patient randomization, its
 registration was approved later because some formatting and data
 adjustments were required. All procedures were performed in accordance
 with the ethical standards of the responsible committee and the
 Declaration of Helsinki. Written informed consent was obtained from the
 children’s parents or guardians before the data were collected and was
 applied by the physician responsible for starting the protocol. The STROBE
 guidelines were applied for text structuring considering the score
 comparison. Local training was carried out with
 physicians and physiotherapists before and during the research for device
 usage and protocol application. Training efficacy evaluation was not
 performed. The HFNC system used was an Airvo 2 (Fisher
 & Paykel), and the initial flow was 2 L.kg.min.
 FiO<sub>2</sub> was titrated to maintain a peripheral oxygen
 saturation between 94 and 99%. All eligible patients who developed mild to
 moderate respiratory distress (classified by WDF score) were connected to
 a nonrebreathing mask until the device was properly installed.
 The inclusion criteria were children under 2 years of age
 admitted for bronchiolitis that progressed to mild to moderate respiratory
 distress (WDF &lt; 8) during hospitalization [27,28]. The exclusion
 criteria were patients with severe respiratory distress, bronchopulmonary
 dysplasia, cyanotic congenital heart disease or hemodynamic repercussion;
 liver disease; neuromuscular disease; or tracheostomy. Infants with a
 viral panel positive for severe acute respiratory syndrome coronavirus 2
 (SARS-CoV-2) and whose parents refused to participate in this study were
 also excluded. The ROX index, WDF score,
 SpO<sub>2</sub>, FiO<sub>2</sub> and vital signs
 were registered at 0 h, 2 h, 6 h, 12 h, 24 h, 48 h, 72 h and 96 h after
 HFNC therapy initiation. The variables assessed included age, weight, sex,
 comorbidities, viral panel identified by reverse transcription polymerase
 chain reaction (RT‒qPCR), time on HFNC, mechanical ventilation duration,
 PICU length of stay (LOS), hospital LOS, and mortality. Data in S1 Table
 and S1 Appendix provide a description of the variables applied in each
 score. The criteria for indicating HFNC failure and
 mechanical ventilation requirements were signs of severe respiratory
 distress (WDF 8 to 14), a respiratory rate &gt; 60 bpm (in children up
 to 1 year old) or &gt; 40 bpm (in children 1 to 2 years old), or a
 heart rate &gt; 160 bpm. For patients who experienced respiratory
 improvement, weaning therapy was administered according to the
 institutional protocol. As a primary outcome, the ROX
 index, WDF, SpO<sub>2</sub>/FiO<sub>2</sub> and
 p-ROXI, which are predictors of HFNC failure,were evaluated. The secondary
 outcomes analyzed were mechanical ventilation duration, PICU LOS, hospital
 LOS, and mortality. The descriptive statistics included
 measures of central dispersion (means and standard deviations, medians,
 and interquartile ranges), in addition to absolute and relative
 frequencies. The Mann‒Whitney U test was used to
 compare distributions. To evaluate correlations, the Spearman test was
 used, and to compare frequencies, the chi-square test was used. Receiver
 operating characteristic (ROC) curves and the Youden index were used to
 identify the best cutoff points for predicting HFNC therapy failure and
 determining thesensitivity and specificity of the cutoff points. The ROC
 curves were compared through the DeLong test. Generalized estimating
 equations (GEEs) were applied to analyze repeated measures of the ROX
 index and WDF. Statistical analysis was performed with R (Vienna,
 Austria). The p-ROXI was calculated according to
 Yildizdas
 (SpO<sub>2</sub>/FiO<sub>2</sub>/respiratory rate
 z score for age). Respiratory rate z scores for age were obtained from
 Sepanski et al [16,30]. The interrater reliability of
 the WDF was not evaluated. The standard method was applied for missing
 data, which is the analysis of complete cases, not using any technique of
 replacement or imputation [31]. The percentages of missing data for each
 period were 0 h (0), 2 h (0.2%), 6 h (0.8%), 12 h (0.9%), 24 h (0.1%), 48
 h (0.7%), 72 h (0) and 96 h (0). Missing data occurred as a result of
 incomplete forms.
description: # Comparative analysis of predictors of failure for high-flow nasal
 cannula in bronchiolitis This dataset contains information on each patient
 randomized to the study. The first row describes the variables registered.
 From the second row onwards, each of them represents the variables of a
 unique patient that include indirect data, values ​​found during the
 period on high-flow nasal cannula and also during hospitalization that
 were used for statistical analysis. *Column legends:* Plot_ID: identifier
 for study plot Ag: age (in months) We_zscore: z-score (weight-for-age) VP:
 viral panel (RSV = respiratory syncytial virus, Bo = bocavirus, SC =
 seasonal coronavirus, Pa = parainfluenza, Ad = adenovirus, Me =
 metapneumovirus, RE = rhino/enterovirus, NA = sample not available) It:
 intubation TD: HFNC/NIV duration in hours \_0 (e.g. HR_0) = heart rate at
 protocol initiation \_2 (e.g. HR_2) = heart rate after 2h of protocol
 initiation \_6 (e.g. HR_6) = heart rate after 6h of protocol initiation
 \_12 (e.g. HR_12) = heart rate after 12h of protocol initiation \_24 (e.g.
 HR_24) = heart rate after 24h of protocol initiation \_48 (e.g. HR_48) =
 heart rate after 48h of protocol initiation \_72 (e.g. HR_72) = heart rate
 after 72h of protocol initiation \_96 (e.g. HR_96) = heart rate after 96h
 of protocol initiation HR: heart rate RR: respiratory rate SpO2:
 peripheral oxygen saturation WD: Wood-Downes-Férres score FiO2: fraction
 of inspired oxygen L/min: liters per minute (HFNC) PLOS: PICU length of
 stay (in days) HLOS: hospital length of stay (in days) MV: mechanical
 ventilation duration (in days) ATB: antibiotic requirement (n = no, y =
 yes) pf: protocol finalized md: missing data nc: not calculated Some
 adjustments were done to facilitate dataset comprehension and to respect
 data sharing for human subjects: 1\) Blank spaces have been eliminated 2\)
 The identification of each column has been adjusted according to the
 standards and described in detail in the README 3\) In the viral panel
 column = the "+" symbol has been eliminated and the results have
 been separated by commas 4\) For protocols that have already been
 finalized, the letter "x" has been replaced by "pf" to
 facilitate understanding 5\) Column “We_zscore”, “Age”, "PLOS"
 and "HLOS": the specific weight (in kilograms), age (in months),
 PICU length of stay (in days) and hospital length of stay (in days) were
 replaced with the respectively ranges (e.g. 4 was replaced with 0-5),
 respecting indirect identifiers open data display 6\) Colored spaces were
 removed without impacting table interpretation 7\) The symbol
 "-" has been replaced by "nc" (not calculated) to
 facilitate understanding 8\) Dataset title was updated to optimize
 discoverability and ensure clarity 9\) "Tr" has been replaced by
 "md" (missing data) and "s" by "y" (yes)