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临床试验/NCT03609866
NCT03609866已完成不适用

the Effects of Manual Thoracic Compression Technique in Intracranial Pressure in Mechanically Ventilated Patients With Acute Cerebral Injury

University of Santiago de Compostela2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
intracranial pressure changes

研究概览

简要总结

The investigators will study the effects of a chest physiotherapy technique (rapid thoracic compression) on the intracranial pressure of individuals with acute cerebral injury and with need of intubated mechanical ventilation

详细描述

Patients with acute brain injury often require invasive mechanical ventilation connection, increasing the risk of developing complications such as respiratory secretions retention. Thethoracic compression is a manual chest physiotherapy technique that can improve clearance of secretions in these patients. Although today the scientific evidence is contradictory, the manual abdomino-thoracic compression may be associated with increased intracranial pressure in patients with acute brain injury.

Objectives: The aim of this work to study the effects of manual thoracic compression technique in intracranial pressure in mechanically ventilated patients. Furthermore, the effects of the technique in different volumes and flows recorded by the ventilator and the relationship between the pressure applied in the intervention group and the different variables will also be studied.

Methodology: It will be a randomized clinical trial, single-blind in the application of the techniques. Patients with acute brain injury in invasive mechanical ventilation will be included, randomized into two groups. In the control group, a technique of passive inferior limbs mobilization will be applied and in the intervention group it will be performed the manual thoracic compression technique. The data of the primary variable, intracranial pressure will be collected with a monitoring system and continuous recording (Integra Camino).

A descriptive analysis of the values collected from the variables in the study will be performed, studying the measures of central tendency. In the presence of normal distribution will be presented mean and standard deviation, and median and interquartile range in case of non-observation of normal distribution. The normality of the samples will be verified with the Kolmogorov-Smirnov test. The verification of the hypothesis in study will be assessed using the Student T test for independent samples in case of sample normality and by the Wilcoxon test otherwise. A multiple linear regression analysis will be performed: considering as a dependent variable the differences in intracranial pressure, difference or volume / minute gain and expiratory flow and between the covariates, the type of technique, the pressure applied in the technique under study, the type of brain injury, age, sex, etc.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
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

  • intubated patients for 48 hours in vc, pc, vcrp
  • hemodynamically stable (MAP>60mmHg)
  • respiratory stability (PEEP<15cmH2O and FiO2<60%)
  • ICP stable (0<icp<20mmHg)
  • RASS of 5
  • informed consent signed

排除标准

  • thoracic fractures
  • abdominal injuries that limits local pressure
  • systemic or local changes that undergoes with abdominal volume increase
  • inferior limbs fractures that contraindicates passive mobilization techniques

结局指标

主要结局

intracranial pressure changes

时间窗: 5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure

with Camino ICP monitoring

次要结局

  • heart rate changes(5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure)
  • cerebral perfusion pressure changes(5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure)
  • oxygen saturation changes(5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure)
  • peak expiratory flow changes(all the respiratory cycles will be recorded 30 seconds before procedure and during the procedure)

研究者

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

ricardo miguel rodrigues gomes

principal investigator

University of Santiago de Compostela

研究点 (2)

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