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临床试验/NCT06167239
NCT06167239招募中不适用

Effect of Ventilator Trigger Sensitivity Adjustment Versus Threshold Inspiratory Muscle Training on Arterial Blood Gases in Mechanically Ventilated Patients, a Randomized Clinical Trail

Cairo University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
1
主要终点
PH

研究概览

简要总结

The aim of the current study is to compare the effect of ventilator trigger sensitivity adjustment versus threshold inspiratory muscle training on arterial blood gases in mechanically ventilated patients.

详细描述

Failed extubations are not uncommon in most ICUs, the failure rate ranging from 2 to 20%. Since failed extubation is associated with greater hospital morbidity and mortality and longer length of stay, it is imperative to identify screening techniques that minimize the number of failed extubations.

Many studies have been done on the effect of IMT by threshold IMT and adjustment of mechanical ventilator trigger separately, thereby, it is rational to compare between two methods of training to know which is more effective to help in weaning process through its effect on ABGs.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Difficult to wean Guillain barre patients who have been on MV for at least 48 hours. Difficult to wean subjects have been defined as those who fail the first spontaneous breathing trial (SBT)and may require up to 3 SBTs or up to 7 d from the first attempt to achieve successful weaning (B´eduneau G. et al.,2017) and (Annia F. et al.,2019).
  • Age: >18 years.
  • Both sexes will be included.
  • Ventilator mode: Pressure support mode with FiO2≤ 0.5, positive end expiratory pressure (PEEP) will be<8-10cm/H2Oand respiratory rate <
  • Conscious oriented patient with Glasgow coma score ≥
  • Alertness will be titrated to a Riker Sedation Agitation Score of
  • PH>7.25, arterial oxygen saturation >90%.
  • Cardiovascular stability.
  • Maximal inspiratory pressure from 15 to 30 cm H2O and able to trigger spontaneous breaths on ventilator.

排除标准

  • Persistent hemodynamic instability as life threatening arrhythmias, acute heart failure.
  • Severe breathlessness, when spontaneously breathing.
  • Any progressive neuromuscular disease that would interfere with responding to inspiratory muscle training (non-stationary course).
  • Spinal cord injury.
  • 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.
  • High peak airway pressure (barotraumas).

结局指标

主要结局

PH

时间窗: Pre intervention and immediate post intervention, through study completion, an average of two weeks

To measure PH

PaCO2

时间窗: Pre intervention and immediate post intervention, through study completion, an average of two weeks

To measure partial pressure of carbon dioxide

HCO3

时间窗: Pre intervention and immediate post intervention, through study completion, an average of two weeks

To measure bicarbonate

PaO2

时间窗: Pre intervention and immediate post intervention, through study completion, an average of two weeks

To measure partial pressure of oxygen

次要结局

  • Minute ventilation(Pre intervention and immediate post intervention, through study completion, an average of two weeks)
  • Weaning success rate(post intervention at the end of the study, an average of two weeks)
  • Rapid shallow breathing index(Pre intervention and immediate post intervention, through study completion, an average of two weeks)
  • The Horowitz index(Pre intervention and immediate post intervention, through study completion, an average of two weeks)
  • Glasgow coma scale(Pre intervention and immediate post intervention, through study completion, an average of two weeks)
  • Respiratory rate(Pre intervention and immediate post intervention, through study completion, an average of two weeks)
  • Riker Sedation-Agitation Scale(Pre intervention and immediate post intervention, through study completion, an average of two weeks)

研究者

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

El-Sayed Essam

Lecturer at Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Cairo University

研究点 (1)

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