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临床试验/NCT03281785
NCT03281785已完成不适用

Ultrasound Evaluation of the Diaphragmatic Musculature in Mechanically Ventilated Patients in Intensive Care Unit

Mansoura University2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2017年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
2
主要终点
Diaphragmatic thickness

研究概览

简要总结

Muscle weakness and dysfunction are common problems in patients hospitalized in the intensive care unit. Respiratory muscle weakness during mechanical ventilation was recognized a state of muscular fatigue. The terminology 'ventilator-induced diaphragmatic dysfunction' (VIDD) originally was introduced to describe these effects of mechanical ventilation and respiratory muscle unloading on the diaphragm.

Ultrasonography is becoming increasingly popular management of ICU patients. It is a simple, non-invasive and safe imaging technique that can be used for the assessment of distinctive diaphragmatic characteristics.

Parameters such as amplitude and velocity of contraction, which can be assessed using M-mode ultrasound. In addition, static and dynamic (thickening fraction during inspiration) diaphragmatic thickness can also be measured by ultrasonography.

详细描述

The aim of this study is to evaluate the effect of different modes of mechanical ventilation on diaphragmatic thickness using ultrasonography and the relation between time of mechanical ventilation and the percentage of change of diaphragmatic thickness in head trauma patients subjected for mechanical ventilation (>2 days) intensive care unit.

Modes of ventilation will be used in the study are:

  • Pressure controlled mandatory ventilation mode (P-CMV).
  • Pressure synchronized intermittent mandatory ventilation mode (P-SIMV).
  • Pressure support (PS) mode.

研究设计

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

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) physical status grades I and II.
  • Glasgow coma scale <
  • Selections of patients need mechanical ventilation (>2 days).
  • Head trauma patients.

排除标准

  • History of diaphragmatic disease
  • Neuromuscular disease
  • Anatomical malformation of the diaphragm.
  • Patients with chest disease
  • Diabetic patients.
  • Chest trauma
  • Chest malignancy.
  • Use of non-invasive ventilation before the start of invasive ventilation.
  • Selection of patients of short period of mechanical ventilation (< 2 days).
  • Hemodynamic instability.
  • Morbid obesity (body mass index > 40 kg/m2).

研究组 & 干预措施

Pressure controlled mandatory ventilation mode (P-CMV)

Active Comparator

Patients will be ventilated using pressure controlled mandatory ventilation mode

干预措施: Pressure controlled mandatory ventilation mode (P-CMV) (Other)

Pressure synchronized intermittent mandatory ventilation

Active Comparator

Patients will be ventilated using pressure synchronized intermittent mandatory ventilation mode (P-SIMV)

干预措施: Pressure synchronized intermittent mandatory ventilation (Other)

Pressure support mode (PS)

Active Comparator

Patents will be ventilated with pressure support mode (PS)

干预措施: Pressure support mode (PS) (Other)

结局指标

主要结局

Diaphragmatic thickness

时间窗: for 3 weeks after initiation of mechanical ventilation

changes in diaphragmatic thickness from baseline to nadir

次要结局

  • Complete blood picture(for 3 weeks after admission to the ICU)
  • Arterial Oxygen Saturation(for 3 weeks after admission to the ICU)
  • mode of ventilation(for 3 weeks after initiation of mechanical ventilation)
  • tidal volume(for 3 weeks after initiation of mechanical ventilation)
  • Liver function(for 3 weeks after admission to the ICU)
  • Glasgow coma scale (GCS)(for 2 weeks after initiation of mechanical ventilation.)
  • Mean blood pressure(for 3 weeks after admission to the ICU)
  • Heart rate(for 3 weeks after admission to the ICU)
  • Central Venous Pressure(for 3 weeks after admission to the ICU)
  • The relation between time of mechanical ventilation and the percentage of change of diaphragmatic thickness(for 3 weeks after initiation of mechanical ventilation)
  • Sequential organ failure assessment (SOFA) score(for 3 weeks after admission to the ICU)
  • Renal function tests(for 3 weeks after admission to the ICU)
  • Coagulation profile(for 3 weeks after admission to the ICU)
  • temperature(for 3 weeks after admission to the ICU)
  • respiratory rate(for 3 weeks after initiation of mechanical ventilation)
  • airway pressure(for 3 weeks after initiation of mechanical ventilation)
  • ICU stay(for 3 weeks after initiation of mechanical ventilation)
  • Duration of mechanical ventilation(for 3 weeks after initiation of mechanical ventilation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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