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临床试验/NCT06593288
NCT06593288尚未招募不适用

Randomized Clinical Trial of Spontaneous Breathing Test

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2025年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
170
试验地点
2
主要终点
Extubation failure

研究概览

简要总结

The hypothesis is that the Spontaneous Breathing Test (SBT) without pressure support (PS) is not inferior to the SBT with pressure support in relation to the following outcomes: a) extubation failure; b) time on MV.

The main objective of this study is to determine whether SBT without PS is non-inferior to SBT with PS in relation to the primary outcome: a) extubation failure; and secondary outcomes: b) length of stay in the PICU and c) days free of MV.

Pacients will be randomized to 2 arms:

  1. SBT with PS
  2. SBT without PS (with PEEP only)

详细描述

Introduction Mechanical ventilation (MV) is a common procedure for patients admitted to pediatric intensive care units (PICUs). Although MV is often necessary and life-saving, it can be associated with complications such as ventilator-associated pneumonia, cardiovascular dysfunction, airway injury, and patient immobility. The longer the duration of MV, the greater the risk of morbidity, length of stay, and mortality. To reduce the risks associated with prolonged MV, clinicians should seek to continually optimize the process of weaning from ventilation (WVL), thereby increasing the likelihood of successful extubation. WVL is defined as "the gradual reduction of mechanical ventilatory support and the transfer of respiratory control and the work of breathing back to the patient." Traditionally, WVL was conducted through clinical judgment and a personal decision. Only in recent years have protocol-based approaches been implemented, with conflicting results, although most studies show that a protocolized approach tends to reduce the duration of mechanical ventilation. Extubation is defined as "removal of the endotracheal tube," and extubation failure occurs when a patient requires reintubation within hours or days of a planned extubation. More recently, extubation failure has been considered as reintubation within 48 hours of a planned extubation. Extubation failure may be secondary to the inability to maintain alveolar oxygenation and/or ventilation, airway patency and protection, secretion control, or any combination of these. Extubation failure occurs in 3-22% of patients regardless of the severity of the underlying disease, with evidence that its occurrence can directly worsen patient outcomes, including an increased mortality rate. Various clinical approaches are used to decide the best timing for extubation, ranging from the use of tools such as chest and diaphragm ultrasound to readiness testing and spontaneous breathing, but there is no clear evidence on which technique is best in children.

Rationale

When using MV, it is important to critically balance the minimization of procedural risks against the risks of extubation failure (EF) and its association with morbidities. The International Guidelines for Liberation from Mechanical Ventilation in Pediatrics were published in 2022 with the aim of guiding best practices for liberation from MV.(2) Experts have given their opinions on the various aspects of liberation from MV. Among several definitions, the most important for this study are:

Extubation readiness test (ERT): (95.7% agreement). It is a set of elements (bundle) that are used to assess the patient's eligibility to be liberated from invasive MV (IMV). In addition to the usual ERT components, such as values of the fraction of inspired oxygen (FiO2), positive end-expiratory pressure (PEEP), the factor that led to tracheal intubation in resolution, ERT may include factors such as: assessment of the level of sedation; neurological adequacy of airway control (coughing and choking); probability of upper airway obstruction after extubation; assessment of respiratory muscle strength; magnitude of airway secretions; hemodynamic status and planning of respiratory support after extubation Spontaneous breathing trial (SBT): (91.3% agreement). Systematic method of reducing IMV support to predetermined parameters to assess the likelihood that the patient will be able to independently maintain minute ventilation and gas exchange without excessive respiratory effort, if released from IMV.

Among the recommendations of the guidelines:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

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

  • Patients admitted to the PICU on MV for more than 24 hours
  • Patients over 1 month old (corrected gestational age > 38 weeks) and < 18 years old on the day of screening for ERT

排除标准

  • Perinatal-related lung disease
  • Congenital diaphragmatic hernia or congenital/acquired paralysis of the diaphragm
  • Children with heart disease
  • Primary pulmonary hypertension
  • Bronchiolitis obliterans
  • Post-hematopoietic stem cell transplant; specifically, patients receiving continuous supplemental oxygen for three or more days prior to intubation; receiving noninvasive ventilation for more than 24 hours prior to intubation; receiving more than one vasoactive medication at the time of meeting the inclusion criteria; spending more than four days in the PICU prior to intubation; supported by or with immediate plans for renal replacement therapy; with two or more allogeneic transplants; who relapsed after transplant; or with diffuse alveolar hemorrhage
  • Post-lung transplantation
  • Home ventilator dependence with baseline Oxygen Saturation Index (OSI) >6 (baseline is defined as a stable period prior to the present illness)
  • Neuromuscular respiratory failure
  • Critical airway obstruction (e.g., post-laryngotracheal surgery or new tracheostomy) or anatomical lower airway obstruction (e.g., mediastinal mass)
  • Facial surgery or trauma in the past two weeks
  • Intracranial bleeding
  • Morbid obesity (2w-24mo: WHO weight-for-length z-score/height z-score ≥+3; ≥2y: WHO body mass index (BMI)-for-age z-score ≥+3)
  • Family/medical team unsupportive total (patient treatment considered futile)
  • Previously enrolled in a current study
  • Enrolled in any other clinical trial with intervention not approved for concomitant enrollment
  • Pregnancy

结局指标

主要结局

Extubation failure

时间窗: 48 hours

Extubation failure: patient needs to be reintubated less than 48 hours after extubation

次要结局

  • Free days of mechanical ventilation(30 days)

研究者

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

Ana Carlotti

Faculty of Medicine of Ribeirao Preto, University of Sao Paulo

University of Sao Paulo

研究点 (2)

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