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临床试验/NCT03880864
NCT03880864Unknown1 期

Application of Lung Ultrasound for Predicting Outcome of Weaning From Mechanical Ventilation

Ain Shams University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年3月7日最近更新:
适应症

试验速览

阶段
1 期
入组人数
50
试验地点
2
主要终点
Number of patients with lung ultrasound score of less than 13

研究概览

简要总结

Lung aeration loss can be measured via lung ultrasound, it is a non-invasive, bed side procedure, which can be performed rapidly and facilitates a dynamic assessment of lung aeration. Aim of the work: is to determine the role of lung ultrasound score as one of the predictors of successful weaning from mechanical ventilation in ICU patients.

详细描述

Patients should be assessed daily for their readiness to be weaned from mechanical ventilation, sedation must be withdrawn and all patients will be put on a spontaneous breathing trial (SBT), via T-piece, for 60 -120 minutes period, when they fulfil the weaning criteria. Patients who succeed to tolerate SBT will be extubated and monitored for signs of respiratory distress.

Clinical assessment during and after SBT:

  • The ability of maintaining a respiration rate of less than 35/min, and keeping oxygen saturation more than 90%.
  • Arterial blood gases (ABGs) will be done 30-60 minutes after SBT and after extubation.
  • To detect signs of respiratory distress: diaphoresis, tachypnea (RR> 35/min), increase activity of accessory muscles of respiration, tachycardia (heart rate > 140 beats per minute), systolic blood pressure > 180 mmHg or <90 mmHg, appearance of new arrhythmia, or alteration in mental status (drowsiness or anxiety). ABGs: PaO2 ≤ 60 mmHg or oxygen saturation < 90% on FiO2 ≥ 0.4, PaCO2 > 50 mmHg, or an increase in by ≥ 8 mmHg, pH < 7.32 or a decrease in pH by ≥ 0.07 pH units.

Clinical assessment will be done by an intensivist who will be blinded to the LUS score results.

Lung ultrasound (LUS): will be performed while patients in supine position, with a curved probe on B- mode, using longitudinal view, to assess the amount of lung aeration. Each lung will be divided into anterior, lateral and posterior regions, each part will be divided to upper and lower zone, with total of 12 zones to undergo examination. Examination will be done by an expert physician in US.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 50 adult patients over 18 years.
  • Mechanically ventilated via an endotracheal tube for more than 24 hours.
  • Patients that have an improvement in the underlying cause of respiratory failure.

排除标准

  • Patients with tracheostomy
  • Spinal cord injury above than T8
  • Arrhythmias and or haemodynamic instability
  • Patients having pneumothorax, or pneumomediastinum, chest tube or chest injuries.
  • After thoracostomy, and pleural lesions or pleurodesis.
  • Patients having severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume less than 50% of predictive value.

结局指标

主要结局

Number of patients with lung ultrasound score of less than 13

时间窗: 48 hours

Successful weaning: patients who will not need re-intubation within 48 hours after extubation.

次要结局

未报告次要终点

研究者

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

Randa Ali Shoukry

Assistant Professor

Ain Shams University

研究点 (2)

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