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Chest Physiotherapy Effects on Intracranial Pressure

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03609866
Enrollment
50
Registered
2018-08-01
Start date
2021-04-01
Completion date
2023-12-30
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Brain Injury

Keywords

intracranial pressure increase, chest physiotherapy, ventilated patients, mechanical ventilation

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.

Interventions

PROCEDURErapid thoracic compression technique

in the expiratory time of the ventilation set, it will be applied a rapid thoracic compression

PROCEDUREinferior limb passive mobilization

it will be performed a passive mobilization technique on the patient

Sponsors

University of Santiago de Compostela
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
intracranial pressure changes5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedurewith Camino ICP monitoring

Secondary

MeasureTime frameDescription
oxygen saturation changes5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedurewith philips monitoring device
peak expiratory flow changesall the respiratory cycles will be recorded 30 seconds before procedure and during the procedurewith maquet servo u and servo i ventilators, the purpose is to identify the best peak expiratory flow before and during the procedure, and to compare them.
heart rate changes5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedurewith philips monitoring device
cerebral perfusion pressure changes5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedurewith philips monitoring device

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026