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临床试验/NCT05865977
NCT05865977招募中不适用

Diaphragmatic Tissue Doppler Imaging During a Spontaneous Breathing Trial to Predict Extubation Failure in Preterm Infants

Wang Jianhui1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Change in diaphragmatic displacement velocity

研究概览

简要总结

Weaning from mechanical ventilation is a critical issue and the diaphragmatic disfunction has been demonstrated to play an important role in extubation failure. the aim of present investigation is to evaluate diaphragmatic excursion velocity during in patients undergoing spontaneous breathing trial through tissue Doppler analysis in both inspiration and expiration.

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
2 Days 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • premature infants with gestational age <32 weeks and supported by invasive mechanical ventilation ≥48 hours
  • All the indications for extubation are met:cough or vomiting due to spontaneous breathing and sputum aspiration; ventilator parameters in recent 24 hours: MAP < 8cmH2O, RR < 30 times/min, FiO2 < 30%; Arterial blood gas: pH > 7.25, (PaCO2< 60mmHg, BE < 8mmol/L, oxygen saturation > 90%
  • a successful SBT
  • parents or legal guardians sign informed consent to attend this study

排除标准

  • accidental extubation
  • chest CT or bronchoscopy during hospitalization indicated congenital airway dysplasia
  • complex congenital heart disease
  • congenital metabolic diseases, neuromuscular diseases
  • severe brain injury
  • surgical mechanical ventilation
  • give up before extubation;
  • pneumothorax or pleural effusion
  • no consent is signed

结局指标

主要结局

Change in diaphragmatic displacement velocity

时间窗: an average of 20 minutes

Inspiratory and expiratory diaphragmatic displacement velocity evaluated with tissue doppler during the assisted ventilation modality which preceded the trial, during the spontaneous breathing trial and in spontaneous breathing.

次要结局

  • Number of patients who experienced weaning failure(48 hours)
  • Silverman Andersen Respiratory Severity Score (SA-RSS)(an average of 20 min)
  • Gas exchange - arterial carbon dioxide tension(through each trial completion, an average of 20 minutes)
  • Gas exchange - pH(an average of 20 minutes)
  • Gas exchange - arterial oxygen tension(an average of 20 min)
  • Diaphragmatic acceleration and deceleration(an average of 20 minutes)

研究者

发起方
Wang Jianhui
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wang Jianhui

Attending doctor

Children's Hospital of Chongqing Medical University

研究点 (1)

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