Clinical trial NCT03609866: Chest Physiotherapy Effects on Intracranial Pressure
Official title: the Effects of Manual Thoracic Compression Technique in Intracranial Pressure in Mechanically Ventilated Patients With Acute Cerebral Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Brain Injury
Keywords: intracranial pressure increase
chest physiotherapy
ventilated patients
mechanical ventilation
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: intracranial pressure changes
timeFrame: 5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure
Secondary outcomes:
measure: oxygen saturation changes
timeFrame: 5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure
measure: peak expiratory flow changes
timeFrame: all the respiratory cycles will be recorded 30 seconds before procedure and during the procedure
measure: heart rate changes
timeFrame: 5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure
measure: cerebral perfusion pressure changes
timeFrame: 5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
state: Galicia
Study officials:
affiliation: University of Santiago de Compostela
name: ricardo m rodrigues gomes, PT MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodrigues-Gomes RM, Marti JD, Rolan RM, Gelabert-Gonzalez M. Rapid chest compression effects on intracranial pressure in patients with acute cerebral injury. Trials. 2022 Apr 15;23(1):312. doi: 10.1186/s13063-022-06189-w.