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Respiratory Mechanics in Brain Injured Patients

NCT ID: NCT00639990

Last Updated: 2008-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-12-31

Brief Summary

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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

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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

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Brain Injury Acute Lung Injury

Keywords

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Intraabdominal pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Patients without lung injury and brain injury

Group Type ACTIVE_COMPARATOR

PEEP

Intervention Type OTHER

Application of positive end expiratory pressure

Brain No ALI 1

Patients with brain injury and no lung injury within 72 hours from ICU entry

Group Type EXPERIMENTAL

PEEP

Intervention Type OTHER

Application of positive end-expiratory pressure

Brain No ALI 2

Patients with brain injury and no ALI after 72 hours from ICU entry

Group Type EXPERIMENTAL

PEEP

Intervention Type OTHER

Application of positive end-expiratory pressure

Brain ALI

Patients with brain injury and Acute Lung Injury (ALI)

Group Type EXPERIMENTAL

PEEP

Intervention Type OTHER

Application of positive end-expiratory pressure

Interventions

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PEEP

Application of positive end expiratory pressure

Intervention Type OTHER

PEEP

Application of positive end-expiratory pressure

Intervention Type OTHER

PEEP

Application of positive end-expiratory pressure

Intervention Type OTHER

PEEP

Application of positive end-expiratory pressure

Intervention Type OTHER

Other Intervention Names

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No brain injury No ALI Brain No ALI 72hrs Brain NO ALI more 72 hrs Brain and ALI

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Pregnancy
* Hemodynamic instability
* Immunodepression
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi dell'Insubria

OTHER

Sponsor Role lead

Responsible Party

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University of Insubria Varese, Italy

Principal Investigators

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Paolo Pelosi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Insubria, Varese

Locations

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Ospedale di Circolo e Fondazione Macchi

Varese, Varese, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paolo Pelosi, MD

Role: CONTACT

Phone: 0039-0332-278801

Email: [email protected]

Facility Contacts

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Paolo Severgnini, MD

Role: primary

Other Identifiers

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No financial support

Identifier Type: -

Identifier Source: secondary_id

003

Identifier Type: -

Identifier Source: org_study_id