Chest Physiotherapy Effects on Intracranial Pressure

NCT ID: NCT03609866

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-12-30

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.

Conditions

Acute Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

control

will be performed inferior limbs passive mobilization

Group Type: ACTIVE_COMPARATOR

inferior limb passive mobilization

Intervention Type: PROCEDURE

it will be performed a passive mobilization technique on the patient

experimental

rapid thoracic compression technique will be applied

Group Type: EXPERIMENTAL

rapid thoracic compression technique

Intervention Type: PROCEDURE

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

Interventions

rapid thoracic compression technique

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

Intervention Type: PROCEDURE

inferior limb passive mobilization

it will be performed a passive mobilization technique on the patient

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Santiago de Compostela

OTHER

Sponsor Role: lead

Responsible Party

ricardo miguel rodrigues gomes

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ricardo m rodrigues gomes, PT MSc

Role: PRINCIPAL_INVESTIGATOR

University of Santiago de Compostela

Locations

Hospital Álvaro Cunqueiro

Vigo, Galicia, Spain

Countries

Spain

References

Rodrigues-Gomes RM, Prieto Campo A, Martinez Rolan R, Gelabert-Gonzalez M. Effects of rapid chest compression technique on intracranial and cerebral perfusion pressures in acute neurocritical patients: a randomized controlled trial. Crit Care. 2025 Apr 23;29(1):159. doi: 10.1186/s13054-025-05405-8.

Reference Type: DERIVED

PMID: 40270039 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35428364 (View on PubMed)

Other Identifiers

Usantiago Doct

Identifier Type: -

Identifier Source: org_study_id