Chest Physiotherapy Effects on Intracranial Pressure

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

Patients with acute brain injury often require invasive mechanical ventilation connection, increasing the risk of developing complications such as respiratory secretions retention. The abdomino-thoracic 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 abdomino-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 ankle mobilization will be applied and in the intervention group it will be performed the manual abdomino-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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03609866
Study type	Interventional
Source	University of Santiago de Compostela
Contact
Status	Completed
Phase	N/A
Start date	April 1, 2021
Completion date	December 30, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.