Brain InjuryNCT00639990
Respiratory Mechanics in Brain Injured Patients
A study testing PEEP in people with Brain Injury and Acute Lung Injury, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
The hypothesis is that brain injury patients have alterations of the respiratory system related to intraabdominal pressure. Furthermore application of moderate levels of PEEP may improve respiratory function in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury, Acute Lung Injury
- What is being tested?
- PEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2007to Dec 2008
- 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
- Male and Female
- Age > 18 yrs
- Mechanical ventilation
- No smoker
- No lung injury at entry
- Brain injury (traumatic or postoperative or spontaneous bleeding) in brain injury group
Who cannot join
- Pregnancy
- Hemodynamic instability
- Immunodepression
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale di Circolo e Fondazione Macchi
Varese, Varese, 21100
Paolo Severgnini, MD, 0039-0332-278801, paolo.severgnini@uninsubria.it
About this study
Official title: Effects of PEEP in Brain Injury Patients
The hypothesis is that brain injury patients have alterations of the respiratory system related to intraabdominal pressure. Furthermore application of moderate levels of PEEP may improve respiratory function in these patients.
Read the detailed description
We investigate the mechanical properties of the respiratory system, partitioned into its lung and chest wall components, the functional residual capacity, the gas-exchange and alveolar recruitment in brain injured patients.
The measurements will be performed under sedation at different levels of PEEP. The following groups will be included: a) control patients withot lung injury and brain injury; b) brain injured patients without lung injury within the first 72 hours; c) brain injured patients without lung injury after 72 hours; d) brain injured patients with lung injury. Brain injury was defined as primary or secondary. Respiratory functional data will be related to intra-abdominal pressure.
- Conditions
- Brain Injury, Acute Lung Injury
- Being tested
- PEEP
- Keywords
- Intraabdominal pressure
- Medical subject headings
- Brain Injuries, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEPOther
Also called No brain injury No ALI
Application of positive end expiratory pressure
PEEPOther
Also called Brain No ALI 72hrs
Application of positive end-expiratory pressure
PEEPOther
Also called Brain NO ALI more 72 hrs
Application of positive end-expiratory pressure
PEEPOther
Also called Brain and ALI
Application of positive end-expiratory pressure
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients without lung injury and brain injury Receives: Other: PEEP |
| Brain No ALI 1 | Experimental | Patients with brain injury and no lung injury within 72 hours from ICU entry Receives: Other: PEEP |
| Brain No ALI 2 | Experimental | Patients with brain injury and no ALI after 72 hours from ICU entry Receives: Other: PEEP |
| Brain ALI | Experimental | Patients with brain injury and Acute Lung Injury (ALI) Receives: Other: PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of respiratory function with PEEP
Measured: 30 min
Secondary outcomes (1)
Relations of respiratory mechanics (lung and chest wall) with intraabdominal pressure
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startJun 2007
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Investigators
- Paolo Pelosi, MD, Principal investigator, University of Insubria, Varese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639990
- Sponsor's protocol ID
- 003
- Other IDs
- No financial support
- Status last verified
- Mar 2008
- First submitted
- 12 Mar 2008
- Last updated
- 20 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of PEEP in Brain Injury Patients
- ClinicalTrials.gov ID
- NCT00639990
- Acronym / sponsor ID
- 003
- Conditions
- Brain Injury, Acute Lung Injury
- Keywords
- Intraabdominal pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 20 Mar 2008 (estimated)
- 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 hypothesis is that brain injury patients have alterations of the respiratory system related to intraabdominal pressure. Furthermore application of moderate levels of PEEP may improve respiratory function in these patients.
Detailed description
We investigate the mechanical properties of the respiratory system, partitioned into its lung and chest wall components, the functional residual capacity, the gas-exchange and alveolar recruitment in brain injured patients.
The measurements will be performed under sedation at different levels of PEEP. The following groups will be included: a) control patients withot lung injury and brain injury; b) brain injured patients without lung injury within the first 72 hours; c) brain injured patients without lung injury after 72 hours; d) brain injured patients with lung injury. Brain injury was defined as primary or secondary. Respiratory functional data will be related to intra-abdominal pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: PEEPPatients without lung injury and brain injury |
| Brain No ALI 1 | Experimental | Other: PEEPPatients with brain injury and no lung injury within 72 hours from ICU entry |
| Brain No ALI 2 | Experimental | Other: PEEPPatients with brain injury and no ALI after 72 hours from ICU entry |
| Brain ALI | Experimental | Other: PEEPPatients with brain injury and Acute Lung Injury (ALI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and Female
- Age > 18 yrs
- Mechanical ventilation
- No smoker
- No lung injury at entry
Key exclusion criteria (3 listed)
- Pregnancy
- Hemodynamic instability
- Immunodepression
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 |
|---|---|---|
| PEEPAlso: No brain injury No ALIApplication of positive end expiratory pressure | Other | Control |
| PEEPAlso: Brain No ALI 72hrsApplication of positive end-expiratory pressure | Other | Brain No ALI 1 |
| PEEPAlso: Brain NO ALI more 72 hrsApplication of positive end-expiratory pressure | Other | Brain No ALI 2 |
| PEEPAlso: Brain and ALIApplication of positive end-expiratory pressure | Other | Brain ALI |
Primary outcome
Improvement of respiratory function with PEEP
Time frame: 30 min
1 secondary outcome
Relations of respiratory mechanics (lung and chest wall) with intraabdominal pressure
Time frame: 30 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2008.
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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.
Paolo Pelosi, MD principal investigator
University of Insubria, Varese
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP in people with Brain Injury and Acute Lung Injury, run by Università degli Studi dell'Insubria at 1 site in Italy.
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 3 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: status not confirmed, as of the sponsor's last update on 20 Mar 2008. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Pelosi, MD (0039-0332-278801, ppelosi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of respiratory function with PEEP (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2008.