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Completed

NCT Number: NCT03609866

Chest Physiotherapy Effects on Intracranial Pressure

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Álvaro Cunqueiro

Vigo, Galicia, 36312, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rapid thoracic compression technique

Procedure

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

inferior limb passive mobilization

Procedure

it will be performed a passive mobilization technique on the patient

Primary outcomes

  1. intracranial pressure changes

    Time frame: 5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure

    with Camino ICP monitoring

Secondary outcomes

  1. oxygen saturation changes

    Time frame: 5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure

    with philips monitoring device

  2. peak expiratory flow changes

    Time frame: all the respiratory cycles will be recorded 30 seconds before procedure and during the procedure

    with 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.

  3. heart rate changes

    Time frame: 5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure

    with philips monitoring device

  4. cerebral perfusion pressure changes

    Time frame: 5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure

    with philips monitoring device

Sponsors and collaborators

Lead sponsor

University of Santiago de Compostela

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2018
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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