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Chest Physiotherapy Effects on Intracranial Pressure

Primary Purpose

Acute Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
rapid thoracic compression technique
metatarsophalangeal joint passive mobilization
Sponsored by
University of Santiago de Compostela
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acute Brain Injury focused on measuring intracranial pressure increase, chest physiotherapy, ventilated patients, mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Álvaro CunqueiroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control

experimental

Arm Description

will be performed metatarsophalangeal joint passive mobilization

rapid thoracic compression technique will be applied

Outcomes

Primary Outcome Measures

intracranial pressure changes
with Camino ICP monitoring

Secondary Outcome Measures

oxygen saturation changes
with philips monitoring device
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.
heart rate changes
with philips monitoring device
cerebral perfusion pressure changes
with philips monitoring device

Full Information

First Posted
July 10, 2018
Last Updated
May 17, 2022
Sponsor
University of Santiago de Compostela
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1. Study Identification

Unique Protocol Identification Number
NCT03609866
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Santiago de Compostela

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Brain Injury
Keywords
intracranial pressure increase, chest physiotherapy, ventilated patients, mechanical ventilation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Active Comparator
Arm Description
will be performed metatarsophalangeal joint passive mobilization
Arm Title
experimental
Arm Type
Experimental
Arm Description
rapid thoracic compression technique will be applied
Intervention Type
Procedure
Intervention Name(s)
rapid thoracic compression technique
Intervention Description
in the expiratory time of the ventilation set, it will be applied a rapid thoracic compression
Intervention Type
Procedure
Intervention Name(s)
metatarsophalangeal joint passive mobilization
Intervention Description
it will be performed a metatarsophalangeal joint passive mobilization technique on the patient
Primary Outcome Measure Information:
Title
intracranial pressure changes
Description
with Camino ICP monitoring
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
Secondary Outcome Measure Information:
Title
oxygen saturation changes
Description
with philips monitoring device
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
Title
peak expiratory flow changes
Description
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.
Time Frame
all the respiratory cycles will be recorded 30 seconds before procedure and during the procedure
Title
heart rate changes
Description
with philips monitoring device
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
Title
cerebral perfusion pressure changes
Description
with philips monitoring device
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ricardo m rodrigues gomes, PT MSc
Phone
0034618060702
Email
ric.mr.gomes@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ricardo m rodrigues gomes, PT MSc
Organizational Affiliation
University of Santiago de Compostela
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Álvaro Cunqueiro
City
Vigo
State/Province
Galicia
ZIP/Postal Code
36312
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ricardo m rodrigues gomes, PT, MSc
Email
ric.mr.gomes@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35428364
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.
Results Reference
derived

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Chest Physiotherapy Effects on Intracranial Pressure

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