Chest Physiotherapy Effects on Intracranial Pressure

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

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

Study Overview

• Status: Completed
• Conditions: Acute Brain Injury
• Intervention / Treatment: Procedure: metatarsophalangeal joint passive mobilization; Procedure: rapid thoracic compression technique

Detailed Description

Patients with acute brain injury often require invasive mechanical ventilation connection, increasing the risk of developing complications such as respiratory secretions retention. The abdomino-thoracic 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 abdomino-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 ankle mobilization will be applied and in the intervention group it will be performed the manual abdomino-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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ricardo m rodrigues gomes, PT MSc; Phone Number: 0034618060702; Email: ric.mr.gomes@gmail.com

Study Locations

• Spain
  • Galicia
    • Vigo, Galicia, Spain, 36312
      • Hospital Alvaro Cunqueiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• intubated patients for 48 hours in vc, pc, vcrp
• hemodynamically stable (MAP>65mmHg)
• respiratory stability (PEEP<10cmH2O and FiO2<60%)
• ICP stable (0<icp<20mmHg)
• RASS of <3
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control; will be performed metatarsophalangeal joint passive mobilization	Procedure: metatarsophalangeal joint passive mobilization; it will be performed a metatarsophalangeal joint passive mobilization technique on the patient
Experimental: experimental; rapid thoracic compression technique will be applied	Procedure: rapid thoracic compression technique; in the expiratory time of the ventilation set, it will be applied a rapid thoracic compression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intracranial pressure changes	with Camino ICP monitoring	5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygen saturation changes	with philips monitoring device	5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure
peak expiratory flow changes	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.	all the respiratory cycles will be recorded 30 seconds before procedure and during the procedure
heart rate changes	with philips monitoring device	5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure
cerebral perfusion pressure changes	with philips monitoring device	5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure

Collaborators and Investigators

• Sponsor: University of Santiago de Compostela
• Investigators: Principal Investigator: ricardo m rodrigues gomes, PT MSc, University of Santiago de Compostela

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: mechanical ventilation; chest physiotherapy; intracranial pressure increase; ventilated patients
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: Usantiago Doct

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No