Acute Brain InjuryNCT03609866
Chest Physiotherapy Effects on Intracranial Pressure
A study testing rapid thoracic compression technique and inferior limb passive mobilization in people with Acute Brain Injury, run by University of Santiago de Compostela at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injury
- What is being tested?
- rapid thoracic compression technique and inferior limb passive mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- rapid thoracic compression technique, inferior limb passive mobilization
- Keywords
- intracranial pressure increase, chest physiotherapy, ventilated patients, mechanical ventilation
- Medical subject headings
- Brain Injuries, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid thoracic compression techniqueProcedure or surgery
in the expiratory time of the ventilation set, it will be applied a rapid thoracic compression
inferior limb passive mobilizationProcedure or surgery
it will be performed a passive mobilization technique on the patient
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | will be performed inferior limbs passive mobilization Receives: Procedure: inferior limb passive mobilization |
| experimental | Experimental | rapid thoracic compression technique will be applied Receives: Procedure: rapid thoracic compression technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracranial pressure changes
with Camino ICP monitoring
Measured: 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
with philips monitoring device
Measured: 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.
Measured: all the respiratory cycles will be recorded 30 seconds before procedure and during the procedure
heart rate changes
with philips monitoring device
Measured: 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
Measured: 5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Apr 2021
- Primary completion30 Sep 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ricardo miguel rodrigues gomes, University of Santiago de Compostela
- Investigators
- ricardo m rodrigues gomes, PT MSc, Principal investigator, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609866
- Sponsor's protocol ID
- Usantiago Doct
- Status last verified
- Apr 2024
- First submitted
- 10 Jul 2018
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40270039Rodrigues-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.
PubMed 35428364
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effects of Manual Thoracic Compression Technique in Intracranial Pressure in Mechanically Ventilated Patients With Acute Cerebral Injury
- ClinicalTrials.gov ID
- NCT03609866
- Acronym / sponsor ID
- Usantiago Doct
- Conditions
- Acute Brain Injury
- Keywords
- intracranial pressure increase, chest physiotherapy, ventilated patients, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Procedure: inferior limb passive mobilizationwill be performed inferior limbs passive mobilization |
| experimental | Experimental | Procedure: rapid thoracic compression techniquerapid thoracic compression technique will be applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rapid thoracic compression techniquein the expiratory time of the ventilation set, it will be applied a rapid thoracic compression | Procedure or surgery | experimental |
| inferior limb passive mobilizationit will be performed a passive mobilization technique on the patient | Procedure or surgery | control |
Primary outcome
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
4 secondary outcomes
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
peak expiratory flow changes
Time frame: all the respiratory cycles will be recorded 30 seconds before procedure and during the procedure
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Derived from this study: PubMed 40270039Rodrigues-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.
- Derived from this study: PubMed 35428364Rodrigues-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ricardo m rodrigues gomes, PT MSc principal investigator
University of Santiago de Compostela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rapid thoracic compression technique and inferior limb passive mobilization in people with Acute Brain Injury, run by University of Santiago de Compostela at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03609866, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.