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临床试验/NCT05344872
NCT05344872已完成不适用

Automatic Tube Compensation Versus Pressure Support for Ventilatory Weaning of Pediatrics Postcardiac Surgery

University of Alexandria2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Minute ventilation

研究概览

简要总结

The ventilator modality of automatic tube compensation (ATC) can provide variable pressure supports during the weaning process to overcome any change in the resistance of the breathing circuit, endotracheal tube, and airways. The aim of the study is to evaluate the automatic tube compensation (ATC) as a tool for ventilatory weaning in pediatrics after surgeries for congenital cardiac anomalies.

详细描述

The ventilator modality of automatic tube compensation (ATC) can provide variable pressure supports during the weaning process to overcome any change in the resistance of the breathing circuit, endotracheal tube, and airways. ATC is effective in overcoming the work of breathing caused by airway resistance to allow successful weaning process and extubation. Pressure support ventilation (PSV) has been widely used in the performance of a spontaneous breathing trial because it can compensate to some extent for the additional work of breathing imposed by the endotracheal tube and the breathing circuit. However, it is difficult to recognise the exact pressure support to overcome the tubing resistance during the weaning process till extubation. The aim of the study is to evaluate the automatic tube compensation (ATC) as a tool for ventilatory weaning in pediatrics after surgeries for congenital cardiac anomalies. The primary objective of our study is to compare the efficacy of ATC versus PS as a modality for ventilatory weaning of pediatric postcardiac surgery as regards effects on work of breathing, lung compliance, and alveolar recruitment. The secondary objective is to determine perioperative predictors of extubation failure (requirement for reintubation and mechanical ventilation after prior successful weaning from ventilation, within 48 hours after extubation) after cardiac surgery. Patients will be included after fulfilling weaning criteria and being pain free. a weaning trial for 30 minutes will be commenced according to the following and assessed by the attending physician:- Group A: Weaning trial will be done for 17 patients using PSV 0 cmH2O with 100% automatic tube compensation (ATC).

Group P: Weaning trial will be done for 17 patients using PSV 8 cmH2O without ATC.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
8 Months 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • pediatric patients (age 8 months to 12 years) who will undergo congenital cardiac surgeries with the same general anesthetic technique and Pecto-intercostal fascial plane block (PIFB) as regional analgesia for pain management.

排除标准

  • (1) Duration of mechanical ventilation is more than 48 hours; (2) Patients on high inotropic support (unstable hemodynamics); (3) Patients with disturbed conscious level; (4) Patients with palliative cardiac shunting procedures (e.g., BT shunt, Glenn shunt).

结局指标

主要结局

Minute ventilation

时间窗: 1 year

Tidal volume (ml/kg) × respiratory rate (breath / minutes)

Oxygenation index (OI)

时间窗: 1 year

mean air way pressure × FIO2/PaO2

Work of breathing (WOB)

时间窗: 1 year

(∆ V × flow × R + Volume/compliance) (J/L/Kg)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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