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Abstract：
BACKGROUND: The objective of this study was to analyze the effects of sedation administration on clinical parameters, comfort status, intubation requirements, and the pediatric intensive care unit (PICU) length of stay (LOS) in children with acute respiratory failure (ARF) receiving noninvasive ventilation (NIV).
METHODS: Thirteen PICUs in Spain participated in a prospective, multicenter, observational trial from January to December 2021. Children with ARF under the age of five who were receiving NIV were included. Clinical information and comfort levels were documented at the time of NIV initiation, as well as at 3, 6, 12, 24, and 48 h. The COMFORT-behavior (COMFORT-B) scale was used to assess the patients\' level of comfort. NIV failure was considered to be a requirement for endotracheal intubation.
RESULTS: A total of 457 patients were included, with a median age of 3.3 months (IQR 1.3-16.1). Two hundred and thirteen children (46.6%) received sedation (sedation group); these patients had a higher heart rate, higher COMFORT-B score, and lower SpO2/FiO2 ratio than did those who did not receive sedation (non-sedation group). A significantly greater improvement in the COMFORT-B score at 3, 6, 12, and 24 h, heart rate at 6 and 12 h, and SpO2/FiO2 ratio at 6 h was observed in the sedation group. Overall, the NIV success rate was 95.6%-intubation was required in 6.1% of the sedation group and in 2.9% of the other group (p = 0.092). Multivariate analysis revealed that the PRISM III score at NIV initiation (OR 1.408; 95% CI 1.230-1.611) and respiratory rate at 3 h (OR 1.043; 95% CI 1.009-1.079) were found to be independent predictors of NIV failure. The PICU LOS was correlated with weight, PRISM III score, respiratory rate at 12 h, SpO2 at 3 h, FiO2 at 12 h, NIV failure and NIV duration. Sedation use was not found to be independently related to NIV failure or to the PICU LOS.
CONCLUSIONS: Sedation use may be useful in children with ARF treated with NIV, as it seems to improve clinical parameters and comfort status but may not increase the NIV failure rate or PICU LOS, even though sedated children were more severe at technique initiation in the present sample.
METHODS: Thirteen PICUs in Spain participated in a prospective, multicenter, observational trial from January to December 2021. Children with ARF under the age of five who were receiving NIV were included. Clinical information and comfort levels were documented at the time of NIV initiation, as well as at 3, 6, 12, 24, and 48 h. The COMFORT-behavior (COMFORT-B) scale was used to assess the patients\' level of comfort. NIV failure was considered to be a requirement for endotracheal intubation.
RESULTS: A total of 457 patients were included, with a median age of 3.3 months (IQR 1.3-16.1). Two hundred and thirteen children (46.6%) received sedation (sedation group); these patients had a higher heart rate, higher COMFORT-B score, and lower SpO2/FiO2 ratio than did those who did not receive sedation (non-sedation group). A significantly greater improvement in the COMFORT-B score at 3, 6, 12, and 24 h, heart rate at 6 and 12 h, and SpO2/FiO2 ratio at 6 h was observed in the sedation group. Overall, the NIV success rate was 95.6%-intubation was required in 6.1% of the sedation group and in 2.9% of the other group (p = 0.092). Multivariate analysis revealed that the PRISM III score at NIV initiation (OR 1.408; 95% CI 1.230-1.611) and respiratory rate at 3 h (OR 1.043; 95% CI 1.009-1.079) were found to be independent predictors of NIV failure. The PICU LOS was correlated with weight, PRISM III score, respiratory rate at 12 h, SpO2 at 3 h, FiO2 at 12 h, NIV failure and NIV duration. Sedation use was not found to be independently related to NIV failure or to the PICU LOS.
CONCLUSIONS: Sedation use may be useful in children with ARF treated with NIV, as it seems to improve clinical parameters and comfort status but may not increase the NIV failure rate or PICU LOS, even though sedated children were more severe at technique initiation in the present sample.
摘要：
背景：本研究的目的是分析镇静给药对临床参数的影响，舒适状态,插管要求,和接受无创通气（NIV）的急性呼吸衰竭（ARF）儿童的儿科重症监护病房（PICU）住院时间（LOS）。
方法：西班牙的13个PICU参加了一项前瞻性研究，多中心，2021年1月至12月的观察性试验.包括正在接受NIV的五岁以下ARF儿童。在NIV开始时记录临床信息和舒适度，以及3、6、12、24和48h。舒适行为(COMFORT-B)量表用于评估患者的舒适水平。NIV失败被认为是气管插管的必要条件。
结果：共纳入457例患者，中位年龄为3.3个月（IQR1.3-16.1）。两百十三名儿童（46.6%）接受了镇静（镇静组）；这些患者的心率较高，更高的COMFORT-B分数，SpO2/FiO2比值低于未接受镇静治疗的患者（非镇静组）。在3、6、12和24h时，COMFORT-B评分的改善明显，心率在6和12小时，在镇静组中观察到6h的SpO2/FiO2比。总的来说,NIV成功率为95.6%-镇静组6.1%和另一组2.9%需要插管(p=0.092).多变量分析显示，NIV开始时的PRISMIII评分（OR1.408;95％CI1.230-1.611）和3h时的呼吸频率（OR1.043;95％CI1.009-1.079）是NIV失败的独立预测因子。PICULOS与体重相关，PRISMIII得分，12小时时的呼吸频率，3h时的SpO2，12h时的FiO2，NIV失败和NIV持续时间。未发现镇静使用与NIV失败或PICULOS独立相关。
结论：镇静可能适用于接受NIV治疗的ARF儿童，因为它似乎改善了临床参数和舒适状态，但可能不会增加NIV失败率或PICULOS，即使在本样本中，镇静儿童在技术开始时更为严重。
方法：西班牙的13个PICU参加了一项前瞻性研究，多中心，2021年1月至12月的观察性试验.包括正在接受NIV的五岁以下ARF儿童。在NIV开始时记录临床信息和舒适度，以及3、6、12、24和48h。舒适行为(COMFORT-B)量表用于评估患者的舒适水平。NIV失败被认为是气管插管的必要条件。
结果：共纳入457例患者，中位年龄为3.3个月（IQR1.3-16.1）。两百十三名儿童（46.6%）接受了镇静（镇静组）；这些患者的心率较高，更高的COMFORT-B分数，SpO2/FiO2比值低于未接受镇静治疗的患者（非镇静组）。在3、6、12和24h时，COMFORT-B评分的改善明显，心率在6和12小时，在镇静组中观察到6h的SpO2/FiO2比。总的来说,NIV成功率为95.6%-镇静组6.1%和另一组2.9%需要插管(p=0.092).多变量分析显示，NIV开始时的PRISMIII评分（OR1.408;95％CI1.230-1.611）和3h时的呼吸频率（OR1.043;95％CI1.009-1.079）是NIV失败的独立预测因子。PICULOS与体重相关，PRISMIII得分，12小时时的呼吸频率，3h时的SpO2，12h时的FiO2，NIV失败和NIV持续时间。未发现镇静使用与NIV失败或PICULOS独立相关。
结论：镇静可能适用于接受NIV治疗的ARF儿童，因为它似乎改善了临床参数和舒适状态，但可能不会增加NIV失败率或PICULOS，即使在本样本中，镇静儿童在技术开始时更为严重。
