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临床试验/NCT06557941
NCT06557941招募中不适用

The Risk Factors of Extubation Failure in Pediatric Intensive Unite Patients at Sohag University Hospitals

Sohag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
successful extubation and weaning from mechanical ventilation

研究概览

简要总结

Up to 20% of MV patients experience EF [10]. EF is defined as the need to reinsert the endotracheal tube to resume MV in patients extubated for less than 48 hours. It has high rates of morbidity and mortality, prolongs the duration of MV and thus causes a longer stay in the PICU and risk of complications such as the need for tracheostomy, the incidence of pneumonia and pulmonary damage, and finally, costs increase as well and death [10, 11] .

详细描述

Mechanical ventilation (MV) is a common life support modality in 40% of pediatric intensive care unit (PICU) patients. The process of ventilatory support follows a continuum of care, beginning with the patient requiring initial support and ending with the ability to sustain spontaneous breathing [1].

Although MV is a cornerstone in critical care medicine, risks and complications associated with prolonged MV include ventilator associated pneumonia (VAP), barotrauma / volutrauma, decreased cardiac filling, ventilator associated diaphragmatic dysfunction and sepsis [6, 8].

Previous studies recommend extubating patient as early as possible according to clinical course and reversal of the leading causes of intubation. The process of extubation consists of the removal of the endotracheal tube when the patient's physiological status recovers allowing the patient to maintain spontaneous breathing [3,4].

Weaning from MV and extubation are vital steps in patients' recovery; however, these steps are associated with significant risks. Balancing the hazards of premature extubation such as extubation failure (EF) and emergent reintubation with those of prolonged MV is a challenge. [4,5] There is currently a paucity of published evidence-based protocols or guidelines to guide this process; therefore, predictors for successful extubation in critically ill children are not always clear cut. This has resulted in wide variation in practice amongst (PICU) providers that is typically based on institutional norms [4,5, 6]. The most common approach to weaning infants and children is gradual reduction of ventilatory settings not requiring changing the ventilator mode [12].

Up to 20% of MV patients experience EF [10]. EF is defined as the need to reinsert the endotracheal tube to resume MV in patients extubated for less than 48 hours. It has high rates of morbidity and mortality, prolongs the duration of MV and thus causes a longer stay in the PICU and risk of complications such as the need for tracheostomy, the incidence of pneumonia and pulmonary damage, and finally, costs increase as well and death [10, 11] .

研究设计

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

入排标准

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

入选标准

  • All patient at PICU < 18 years subjected to MV through an endotracheal tube at least >12 hours.
  • Patients eligible for weaning from MV according to the weaning criteria (Evidence for some reversal of the underlying cause following for respiratory failure, Adequate oxygenation" PaO2/FIO2 ratio ≥ 200, FIO2 ≤ 0.40, PaO2 ≥ 60, PaCO2 ≤ 60 and PEEP ≤ 5 cmH2O.", PH ≥ 7.25, Respiratory rate (RR) ≤ 45 bpm, Heart rate (HR) ≤ 140 bpm,(rapid shallow breathing index = tidal volume / RR) RSBI ≤ 8 breaths/min/ml/kg body weight, Hemodynamic stable, no or minimal vasopressor or inotropes"[1,12],.
  • Appropriate level of consciousness, No continuous sedation infusion nor neuromuscular blocking agents, afebrile, adequate hemoglobin ≥ 7.5 g/dl and/or no evidence of hemorrhage.

排除标准

  • Patients less than 30 days.
  • Tracheostomized patients.
  • Death on mv ≤ 12 hours.
  • Unplanned extubation.

结局指标

主要结局

successful extubation and weaning from mechanical ventilation

时间窗: 48 hours

passing spontaneous trial and air leak test and not requiring to be re-intubated within 2 days

failed extubation , failed weaning from mechanical ventilation

时间窗: 48 hours

not passing spontaneous trial and air leak test and not requiring to be re-intubated within 2 days

次要结局

  • survival or death(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariam Rafaat Helmy

postgraduate pediatriacian

Sohag University

研究点 (1)

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