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临床试验/NCT04419376
NCT04419376已完成不适用

Driving Pressure and Mortality: in the Pediatric Intensive Care Unit (PICU)

Dr. Behcet Uz Children's Hospital1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2018年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
116
试验地点
1
主要终点
Driving pressure and mortality with all patients

研究概览

简要总结

Respiratory failure is one of the most common causes of both hospitalization and mortality in patients in the pediatric intensive care unit (PICU). Recently, it is recommended to target driving pressure (ΔP) in patients with ARDS to achieve better results with the administration of optimal mechanical ventilation. In many studies, higher ΔP was associated with mortality in adult ARDS patients; non-ARDS patients' studies showing the relationship between driving pressure and mortality are few, but contradictory results have come out.

This study aimed to determine whether ΔP was associated with mortality in pediatric patients diagnosed as pARDS and non-pARDS who received mechanical ventilation support due to respiratory failure. Patients who received invasive mechanical ventilation support due to respiratory failure in the pediatric intensive care unit over 1 month and under 18 years were included in our study Driving pressure was significantly associated with an increased risk of mortality among mechanically ventilated both pARDS and non-pARDS patients. Future prospective randomized clinical trials are needed to determine a protocol targeting DP can be developed and defining optimum cutoff values.

详细描述

Respiratory failure is one of the most common causes of both hospitalization and mortality in patients in the pediatric intensive care unit (PICU). Recently, it is recommended to target driving pressure (ΔP) in patients with ARDS to achieve better results with the administration of optimal mechanical ventilation. ΔP is calculated as the difference between Plateau pressure (Pplat) and positive end-expiratory pressure (PEEP) and is determined by the ratio of the tidal volume to the compliance of the respiratory system (ΔP = Pplat - PEEP = VT/CRS). ΔP estimates how much mechanical strain (dynamic strain) the tidal volume causes in the lung. It is a non-invasive and simple method and can be easily calculated at the bedside. In many studies, higher ΔP was associated with mortality in adult ARDS patients; non-ARDS patients' studies showing the relationship between driving pressure and mortality are few, but contradictory results have come out.

This study aimed to determine whether ΔP was associated with mortality in pediatric patients diagnosed as pARDS and non-pARDS who received mechanical ventilation support due to respiratory failure.

Single-center, prospective, observational study of patients admitted to pediatric intensive care units (PICU) in Turkey. In our study, the ethics committee was approved by The Health Sciences University Izmir Behcet Uz Child Health and Diseases education and research hospital ethics committee (protocol no: 2019-344).In our study, patients who received invasive mechanical ventilation support due to respiratory failure in the pediatric intensive care unit over 1 month and under 18 years were included in the study between March 2018 and April 2020. Mechanically ventilated patients (via ETT or trachestomy) were recorded for patients whose ventilation duration lasted at least 24 hours. We divided the patients into two groups by calculating the oxygenation index (OI): [mean airway pressure(MAP) × fraction of inspired oxygen (FiO2) ]/ partial pressure of oxygen in arterial blood (PaO2) × 100) used in the classification of PALICC, including ARDS and non-ARDS. PARDS definition was also identified based on the PALICC criteria. Data were prospectively recorded on day 1 including patient demographics, ventilator settings (VT, VT / ideal body weight (IBW), respiratory rate (RR), peak inspiratory pressure (PIP), plateau pressure (Pplat), mean airway pressure (Pmean), minute volume (VE), end-expiratory pressure (PEEP), static compliance (Cstat), fraction of inspired oxygen FIO2, inspiratory time ( IT), expiratory time (ET) and we calculated oxygenation index (OI), cstat (VT/∆P), partial pressure of oxygen in arterial blood (PaO2) /FiO2, driving pressure (ΔP), the pediatric index of mortality (PRISM) III scores and pediatric sequential organ failure assessment (pSOFA) scores.

All patients were ventilated with volume control (VCV) or pressure control (PCV) mode during the hospitalization. İn order to measure the driving pressure of patients, Pplat was measured in the mechanical ventilator every 12 hours using an inspiratory hold maneuver. The average Pplat was calculated using the mean of 2 measurements within 24 hours. Then, the total PEEP was measured by expiratory hold maneuver and ΔP was calculated with the Pplat-PEEP formula. Patients were followed for 30 days until hospital discharge. We used ΔP compared to other mechanic ventilator parameters between survivors and non-survivors at day 30. Besides, ΔP and other parameters of patients in the ARDS and non-ARDS groups were compared with their 30-day mortality.

Statistical Analyses Primarily, we evaluated the relationship between ΔP and mortality in patients with ARDS and non-ARDS. Our second target was to evaluate the relationship between mortality and ΔP and other mechanical ventilator parameters.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • In our study, patients who received invasive mechanical ventilation support for at least 24 hours due to respiratory failure in the pediatric intensive care unit over 1 month and under 18 years were included in the study between March 2018 and April 2020.

排除标准

  • patients who died within the first 24 hours and patients whose desired respiratory mechanics were not measured and data deficiencies were detected

结局指标

主要结局

Driving pressure and mortality with all patients

时间窗: march 2018-april 2020

Driving pressure and other lung dynamics; according to the type and distribution of the data was compared with chi-square, Wilcoxon, Independent-T-test or Mann-Whitney-U test and p \<0.05 was considered statistically significant.

次要结局

  • Driving pressure with mortality in patients with pARDS and non-pARDS patients(march 2018-april 2020)

研究者

发起方
Dr. Behcet Uz Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ekin soydan

Principal Investigator

Dr. Behcet Uz Children's Hospital

研究点 (1)

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