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临床试验/NCT07003867
NCT07003867已完成不适用

Ventilator Inspiratory Trigger Sensitivity Adjustment Versus Threshold Device Training on Pulmonary Functions in Acute Stroke Patients

Al-Zaytoonah University of Jordan1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月10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
40
试验地点
1
主要终点
Pulmonary compliance ( mL/cmH2O )

研究概览

简要总结

Neurological dysfunction is a common condition necessitating prolonged mechanical ventilation (PMV). Among patients with acute neurological diseases, 17% to 33% are intubated and mechanically ventilated for respiratory failure. Patients with acute neurological diseases requiring MV generally have adverse outcomes with a hospital mortality rate among patients with such diseases has been reported to be in the range of 16-33%. Inspiratory muscle weakness is common in patients receiving mechanical ventilation, especially patients with prolonged duration of mechanical ventilation. Inspiratory muscle training could limit or reverse these unhelpful squeal and facilitate more rapid and successful weaning.Hence, the importance of physical therapy emerged in helping patients to be weaned from ventilators by using various methods to strengthen the respiratory muscles in different ways.

详细描述

Mechanical ventilation (MV) is a life-saving intervention used worldwide in an estimated 15 million patients annually. Although70% of patients in intensive care units wean without difficulty on the first attempt, approximately 30% require prolonged weaning. Prolonged mechanical ventilation is associated with an increased risk of death ,poor long-term functional outcomes, and markedly higher healthcare costsMechanical Ventilation (MV) is used to restore or enhance pulmonary gas exchange in patients who are unable to maintain adequate alveolar ventilation. Conditions that necessitate the use of MV include but are not restricted to neuromuscular diseases, respiratory failure secondary to chronic obstructive lung disease and following surgery with general anesthesia . A high proportion of patients who require prolonged MV for more than 48 hours do not survive for 1 year, and those who survive have a significantly reduced functional status and quality of life . Prolonged MV has a detrimental impact on the diaphragm, and this has been termed as Ventilator-Induced Diaphragmatic Dysfunction (VIDD ).Inspiratory muscle training is a type of training in which the patient inhales against resistive loads or pressure threshold-loads while the expiration is unloaded, that applies a load to the diaphragm and accessory inspiratory muscles to increase their strength and endurance .The trigger phase corresponds to the process in which the patient's spontaneous breathing triggers the ventilator to work. The inhalation phase corresponds to the process in which PAW rises to the plateau pressure while maintaining pressure support

研究设计

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

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 40-60 years.
  • •Diagnosed with acute stroke patients.
  • •Body mass index (BMI) 18:35 kg/m².
  • •conscious oriented patients with Glasgow coma score ≥
  • •PH>7.25 and arterial oxygen saturation >90%

排除标准

  • •Persistent hemodynamic instability as life threatening arrhythmias, acute heart failure, angina.
  • •Severe breathlessness when spontaneously breathing.
  • •Any progressive neuromuscular disease that would interfere with responding to inspiratory muscle training.
  • •Spinal cord injuries.
  • •Skeletal pathology (scoliosis, flail chest, spinal instrumentation) that would seriously impair the movement of the chest wall and ribs.
  • •Patients on heavy sedation and respiratory muscle paralysis

研究组 & 干预措施

Control group ( threshold inspiratory muscle training )

Active Comparator

干预措施: Ventilator inspiratory trigger sensitivity adjustment , threshold device training (Other)

Experimental group ( Adjustment of ventilator trigger sensitivity )

Experimental

干预措施: Ventilator inspiratory trigger sensitivity adjustment , threshold device training (Other)

结局指标

主要结局

Pulmonary compliance ( mL/cmH2O )

时间窗: pre and post 1 week

A measure of the lung expandability, which is important in ideal respiratory system function. It refers to the ability of the lungs to stretch and expand. Lung compliance can be calculated by dividing volume by pressure (C = V/P), Pulmonary compliance was assessed daily in all mechanically ventilated patients using data obtained directly from the ventilator system (CARESCAPE -R860/USA)

次要结局

  • Paco2 (mmHg)(pre and post 1 week of intervention)
  • PaO2 ( mmHg )(pre and post 1 week of intervention)
  • HCO3 ( mEq/L )(Pre and post 1 week of intervention)
  • pH(Pre and post 1 week of intervention)

研究者

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

Mohamed Saied Zidan

Assistant prof dr

Al-Zaytoonah University of Jordan

研究点 (1)

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