Respiratory Mechanics in Brain Injured Patients

March 12, 2008 updated by: Università degli Studi dell'Insubria

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Varese, Italy, 21100
        • Recruiting
        • Ospedale di Circolo e Fondazione Macchi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Patients without lung injury and brain injury
Other: PEEP
Application of positive end expiratory pressure
Other Names:
  • No brain injury No ALI
Other: PEEP
Application of positive end-expiratory pressure
Other Names:
  • Brain and ALI
Experimental: Brain No ALI 1
Patients with brain injury and no lung injury within 72 hours from ICU entry
Other: PEEP
Application of positive end expiratory pressure
Other Names:
  • No brain injury No ALI
Other: PEEP
Application of positive end-expiratory pressure
Other Names:
  • Brain and ALI
Experimental: Brain No ALI 2
Patients with brain injury and no ALI after 72 hours from ICU entry
Other: PEEP
Application of positive end expiratory pressure
Other Names:
  • No brain injury No ALI
Other: PEEP
Application of positive end-expiratory pressure
Other Names:
  • Brain and ALI
Experimental: Brain ALI
Patients with brain injury and Acute Lung Injury (ALI)
Other: PEEP
Application of positive end expiratory pressure
Other Names:
  • No brain injury No ALI
Other: PEEP
Application of positive end-expiratory pressure
Other Names:
  • Brain and ALI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of respiratory function with PEEP
Time Frame: 30 min
30 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Relations of respiratory mechanics (lung and chest wall) with intraabdominal pressure
Time Frame: 30 min
30 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi dell'Insubria

Investigators

  • Principal Investigator: Paolo Pelosi, MD, University of Insubria, Varese

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 20, 2008

Study Record Updates

Last Update Posted (Estimate)

March 20, 2008

Last Update Submitted That Met QC Criteria

March 12, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003 (033)
  • No financial support

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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