Back to resultsRespiratory Mechanics in Brain Injured Patients
Primary Purpose
Brain Injury, Acute Lung Injury
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PEEP
PEEP
PEEP
PEEP
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injury focused on measuring Intraabdominal pressure
Eligibility 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
Sites / Locations
- Ospedale di Circolo e Fondazione MacchiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Control
Brain No ALI 1
Brain No ALI 2
Brain ALI
Arm Description
Patients without lung injury and brain injury
Patients with brain injury and no lung injury within 72 hours from ICU entry
Patients with brain injury and no ALI after 72 hours from ICU entry
Patients with brain injury and Acute Lung Injury (ALI)
Outcomes
Primary Outcome Measures
Improvement of respiratory function with PEEP
Secondary Outcome Measures
Relations of respiratory mechanics (lung and chest wall) with intraabdominal pressure
Full Information
NCT ID
NCT00639990
First Posted
March 12, 2008
Last Updated
March 12, 2008
Sponsor
Università degli Studi dell'Insubria
1. Study Identification
Unique Protocol Identification Number
NCT00639990
Brief Title
Respiratory Mechanics in Brain Injured Patients
Official Title
Effects of PEEP in Brain Injury Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Università degli Studi dell'Insubria
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury, Acute Lung Injury
Keywords
Intraabdominal pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients without lung injury and brain injury
Arm Title
Brain No ALI 1
Arm Type
Experimental
Arm Description
Patients with brain injury and no lung injury within 72 hours from ICU entry
Arm Title
Brain No ALI 2
Arm Type
Experimental
Arm Description
Patients with brain injury and no ALI after 72 hours from ICU entry
Arm Title
Brain ALI
Arm Type
Experimental
Arm Description
Patients with brain injury and Acute Lung Injury (ALI)
Intervention Type
Other
Intervention Name(s)
PEEP
Other Intervention Name(s)
No brain injury No ALI
Intervention Description
Application of positive end expiratory pressure
Intervention Type
Other
Intervention Name(s)
PEEP
Other Intervention Name(s)
Brain No ALI 72hrs
Intervention Description
Application of positive end-expiratory pressure
Intervention Type
Other
Intervention Name(s)
PEEP
Other Intervention Name(s)
Brain NO ALI more 72 hrs
Intervention Description
Application of positive end-expiratory pressure
Intervention Type
Other
Intervention Name(s)
PEEP
Other Intervention Name(s)
Brain and ALI
Intervention Description
Application of positive end-expiratory pressure
Primary Outcome Measure Information:
Title
Improvement of respiratory function with PEEP
Time Frame
30 min
Secondary Outcome Measure Information:
Title
Relations of respiratory mechanics (lung and chest wall) with intraabdominal pressure
Time Frame
30 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Pelosi, MD
Phone
0039-0332-278801
Email
ppelosi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Pelosi, MD
Organizational Affiliation
University of Insubria, Varese
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Severgnini, MD
Phone
0039-0332-278801
Email
paolo.severgnini@uninsubria.it
12. IPD Sharing Statement
Learn more about this trial
Respiratory Mechanics in Brain Injured Patients
We'll reach out to this number within 24 hrs