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Respiratory Mechanics in Brain Injured Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Università degli Studi dell'Insubria.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT00639990
First received: March 12, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  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: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of PEEP in Brain Injury Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Università degli Studi dell'Insubria:

Primary Outcome Measures:
  • Improvement of respiratory function with PEEP [ Time Frame: 30 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relations of respiratory mechanics (lung and chest wall) with intraabdominal pressure [ Time Frame: 30 min ] [ Designated as safety issue: No ]

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
Active Comparator: Control
Patients without lung injury and brain injury
 Other: PEEP
Application of positive end expiratory pressure
Other Name: No brain injury No 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 Name: Brain No ALI 72hrs
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 Name: Brain NO ALI more 72 hrs
Experimental: Brain ALI
Patients with brain injury and Acute Lung Injury (ALI)
 Other: PEEP
Application of positive end-expiratory pressure
Other Name: Brain and ALI

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639990

Contacts
Contact: Paolo Pelosi, MD 0039-0332-278801 ppelosi@hotmail.com

Locations
Italy
Ospedale di Circolo e Fondazione Macchi Recruiting
Varese, Italy, 21100
Contact: Paolo Severgnini, MD     0039-0332-278801     paolo.severgnini@uninsubria.it    
Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
Principal Investigator: Paolo Pelosi, MD University of Insubria, Varese
  More Information

No publications provided

Responsible Party: Pelosi Paolo, University of Insubria Varese, Italy
ClinicalTrials.gov Identifier: NCT00639990     History of Changes
Other Study ID Numbers: 003, No financial support
Study First Received: March 12, 2008
Last Updated: March 12, 2008
Health Authority: Italy: National Institute of Health

Keywords provided by Università degli Studi dell'Insubria:
Intraabdominal pressure

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Brain Injuries
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Thoracic Injuries

ClinicalTrials.gov processed this record on May 19, 2013