NCT03609866

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
2.7 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

2.5 years

First QC Date

July 10, 2018

Last Update Submit

April 22, 2024

Conditions

Acute Brain Injury

Keywords

intracranial pressure increasechest physiotherapyventilated patientsmechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • oxygen saturation changes

    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

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

  • heart rate changes

    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

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

Study Arms (2)

control

ACTIVE COMPARATOR

will be performed inferior limbs passive mobilization

Procedure: inferior limb passive mobilization

experimental

EXPERIMENTAL

rapid thoracic compression technique will be applied

Procedure: rapid thoracic compression technique

Interventions

rapid thoracic compression techniquePROCEDURE

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

experimental
inferior limb passive mobilizationPROCEDURE

it will be performed a passive mobilization technique on the patient

control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Álvaro Cunqueiro

Vigo, Galicia, 36312, Spain

Location

Related Publications (2)

  • 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.

    PMID: 40270039DERIVED

  • 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.

    PMID: 35428364DERIVED

MeSH Terms

Conditions

Brain InjuriesIntracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • ricardo m rodrigues gomes, PT MSc

    University of Santiago de Compostela

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 10, 2018

First Posted

August 1, 2018

Study Start

April 1, 2021

Primary Completion

September 30, 2023

Study Completion

December 30, 2023

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)