Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03609866 |
| Other study ID # |
Usantiago Doct |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
December 30, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
University of Santiago de Compostela |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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
Description:
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.
