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临床试验/NCT00922493
NCT00922493已完成4 期

Weaning Process in Elderly Intubated Patients Submitted to Inspiratory Muscle Training

Euro-American Network of Human Kinetics2 个研究点 分布在 1 个国家开始时间: 2007年12月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
试验地点
2
主要终点
Measurement of the MIP

研究概览

简要总结

Background: the objective of the present inquiry was to evaluate the weaning process in intubated older people subjected to inspiratory muscle training and to correlate the predictors of ventilatory interruption with its success.

Methods: the patients were divided randomly into an experimental group (EG, n=14; age=82±4 years) that received conventional physiotherapy plus inspiratory muscle training (IMT) with threshold IMT® and a control group (CG, n=14; age=81±6 years) that received only conventional physiotherapy. The predictors evaluates were the maximum inspiratory pressure (MIP) and the index of Tobin (IT). The protocol for muscle training consisted of an initial load of 30% MIP, which was increased by 10% daily; training was administered for five minutes, twice a day, seven times a week with supplemental oxygen for the entire period from the decision to wean up to extubation.

详细描述

The sample for this investigation was selected in a randomized way in the period between December 2007 and November 2008. The individuals were successively entered in the research as they were admitted to the ICU, in respect of the criteria of inclusion and exclusion. From the total number of admitted patients in the period (n=67), many were excluded because they had been tracheostomized (n=25), were dead (n=13) or were transferred out of the hospital (n=1). Those that remained intubated (n=28) and went to the spontaneous mode were chosen randomly and in alternating fashion were divided into the experimental group (EG) or the control group (CG). The EG (n=14; age=82±4 years-old) underwent conventional physiotherapy plus inspiratory muscular training with threshold IMT® (Respironics/EUA - 2004), and the CG (n=14; age=81±6 years-old) received only conventional physiotherapy with no intervention that favored the inspiratory muscle strengthening.

As inclusion criteria, the individuals of the sample were required to have undergone MV for at least 48 hours in a controlled way13, as intubation is diagnostic for acute respiratory injury type 1 and has a maximum value of MIP of -20 cmH2O16.

Exclusion criteria included any type of acute condition (cardiac arrhythmia) or chronic condition, such as insufficient congestive heart failure or unstable ischemic cardiac disease17, that could compromise weaning or could impede the accomplishment of inspiratory muscle training (neuropathy and myopathy). Tracheostomized patients (in the pre-test), those with neurological problems (cerebral vascular accident, cerebrospinal trauma or spinal medullar trauma), those with morbid obesity or those taking medicine that could cause a disorder of attention, as well as cases of auto-extubation, were also excluded.

The criteria of inclusion and exclusion were evaluated via examination of the patients' medical records and physical examination daily and in each session. The daily adherence of the patients to the necessary parameters for the study was noted for each patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the individuals of the sample were required to have undergone Mechanical Ventilation for at least 48 hours in a controlled way
  • intubation is diagnostic for acute respiratory injury type 1
  • has a maximum value of MIP of -20 cmH2O16

排除标准

  • any type of acute condition (cardiac arrhythmia) or chronic condition, such as insufficient congestive heart failure or unstable ischemic cardiac disease, that could compromise weaning or could impede the accomplishment of inspiratory muscle training (neuropathy and myopathy).
  • Tracheostomized patients (in the pre-test).
  • patients with neurological problems (cerebral vascular accident, cerebrospinal trauma or spinal medullar trauma.
  • patients with morbid obesity
  • patients taking medicine that could cause a disorder of attention.
  • cases of auto-extubation.

结局指标

主要结局

Measurement of the MIP

次要结局

  • Measurement of rapid shallow breathing (IT)

研究者

发起方
Euro-American Network of Human Kinetics
申办方类型
Other

研究点 (2)

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