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临床试验/NCT05480371
NCT05480371Unknown不适用

Role of Cough Assist Device in Mechanically Ventilated Patients in Respiratory Intensive Care Unit : Assiut University Experience

Assiut University0 个研究点目标入组 200 人开始时间: 2022年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
主要终点
Assess effects of MIE on Volume of Secretions

研究概览

简要总结

Aspiration of respiratory secretions is a frequently needed procedure in intubated patients .

Cough is an important defence mechanism to clear mucus from the upper and lower airways . The presence of an endotracheal tube impairs the ability to cough.There are a number of techniques to mobilise sputum and optimise airway clearance for invasively ventilated patients. Endotracheal suctioning is the most common intervention used to remove retained airway secretions from within the endotracheal tube, trachea and upper airways .Mechanical insufflation-exsufflation (MI-E) aids sputum clearance from upper and lower airways. This technique augments inspiratory and expiratory flows to improve sputum mobilisation, through the application of rapidly alternating positive and negative pressure, which approximates a normal cough

详细描述

Critically ill patients under invasive ventilation are at risk for sputum retention . Aspiration of respiratory secretions is a frequently needed procedure in intubated patients .

Cough is an important defence mechanism to clear mucus from the upper and lower airways . The presence of an endotracheal tube impairs the ability to cough. This prevents the enhancement of cough velocity . Furthermore, critically ill patients frequently have an impaired or no cough reflex due to depressed levels of consciousness, sedation, muscle weakness or muscle paralysis. Sputum retention, resulting from an inability to cough effectively, is one cause of extubation failure which in turn is associated with increased mortality.

There are a number of techniques to mobilise sputum and optimise airway clearance for invasively ventilated patients. Endotracheal suctioning is the most common intervention used to remove retained airway secretions from within the endotracheal tube, trachea and upper airways . Endotracheal suctioning though is not effective for clearing secretions from the lower airways .

New technologies and advanced methods have been developed to increase the effectiveness of mucus clearance in patients with acute respiratory failure, including mechanical insufflation-exsufflation devices. This technique has been described as an effective aid for mucus clearance in patients with chronic muscle weakness or neuromuscular disease.

Mechanical insufflation-exsufflation (MI-E) aids sputum clearance from upper and lower airways. This technique augments inspiratory and expiratory flows to improve sputum mobilisation, through the application of rapidly alternating positive and negative pressure, which approximates a normal cough .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, 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

  • Adult patients of both sexes on mechanical ventilation in RICU with any respiratory disease
  • Mechanically ventilated Patients without facial trauma
  • Mechanically ventilated Patients hemodynamically stable

排除标准

  • Patients diagnosed with barotrauma
  • Patients diagnosed with pneumothorax
  • History of bullous emphysema Known susceptibility to pneumothorax or pneumo-mediastinum

研究组 & 干预措施

Conventional endotracheal suctioning

Active Comparator

Tracheal suctioning will be performed following the American Association for Respiratory Care recommendations: closed suction system, suction catheter with maximal internal-to-external diameter ratio of 0.5, delivery of 100% oxygen 30 s immediately before and 1 min after the procedure, duration of 15 s, and vacuum pressure of ±150 mmHg

干预措施: Conventional tracheal suctioning (Device)

mechanical insufflation exsufflation

Experimental

The mechanical insufflation-exsufflation will be performed with the which will be applied 5 times in 5cough cycles in automatic mode, with insufflation and exsufflation pressures of + 40/-40 cmH2O, respectively. The duration of each phase was 3 s, without pause, and tracheal suctioning will be performed at the end of the procedure. Hyperoxygenation (100% O2) will be performed for 1 min before applying each technique and a 20 s interval will be allowed between repetitions. The secretion collected after each procedure will be stored in a disposable bronchial secretion collector for later weighing

干预措施: Mechanical insufflation/exsufflation (Device)

结局指标

主要结局

Assess effects of MIE on Volume of Secretions

时间窗: 1 year

Volume of Secretions measured in ml

Assess effects of MIE on respiratory rate

时间窗: 1 year

Respiratory rate measured by breaths per minute

Assess effects of MIE on tidal volume

时间窗: 1 year

Tidal volume measured in cubic centimeter

Assess effects of MIE on minute ventilation

时间窗: 1 year

Assess effects of MIE on Oxygen saturation

时间窗: 1 year

Assess effects of MIE on heart rate

时间窗: 1 year

Heart rate measured by beats per minute

Assess effects of MIE on blood pressur

时间窗: 1 year

Blood pressure measuered in mmHg

次要结局

  • Assess safety of Mechanical insufflation-exsufflation(1 year)

研究者

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

Hadeer Sayed Khalifa

Principal Investigator

Assiut University

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