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| Sponsored by: |
Università degli Studi dell'Insubria |
|---|---|
| Information provided by: | Università degli Studi dell'Insubria |
| ClinicalTrials.gov Identifier: | NCT00639990 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Brain Injury Acute Lung Injury |
Other: PEEP |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment |
| Official Title: | Effects of PEEP in Brain Injury Patients |
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Control: Active Comparator
Patients without lung injury and brain injury
|
Other: PEEP
Application of positive end expiratory pressure
|
|
Brain No ALI 1: Experimental
Patients with brain injury and no lung injury within 72 hours from ICU entry
|
Other: PEEP
Application of positive end-expiratory pressure
|
|
Brain No ALI 2: Experimental
Patients with brain injury and no ALI after 72 hours from ICU entry
|
Other: PEEP
Application of positive end-expiratory pressure
|
|
Brain ALI: Experimental
Patients with brain injury and Acute Lung Injury (ALI)
|
Other: PEEP
Application of positive end-expiratory pressure
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Paolo Pelosi, MD | 0039-0332-278801 | ppelosi@hotmail.com |
| Italy | |
| Ospedale di Circolo e Fondazione Macchi | Recruiting |
| Varese, Italy, 21100 | |
| Contact: Paolo Severgnini, MD 0039-0332-278801 paolo.severgnini@uninsubria.it | |
| Principal Investigator: | Paolo Pelosi, MD | University of Insubria, Varese |
More Information
| Responsible Party: | University of Insubria Varese, Italy ( Pelosi Paolo ) |
| Study ID Numbers: | 003, No financial support |
| Study First Received: | March 12, 2008 |
| Last Updated: | March 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00639990 |
| Health Authority: | Italy: National Institute of Health |
|
Intraabdominal pressure |
|
Craniocerebral Trauma Respiratory Tract Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome, Adult Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Acute respiratory distress syndrome Trauma, Nervous System Brain Diseases Brain Injuries |
|
Nervous System Diseases |
