Respiratory Mechanics in Brain Injured Patients | NCT00639990

Studies
Respiratory Mechanics in Brain Injured Patients

NCT00639990

Sponsor

Università degli Studi dell'Insubria

Status

Unknown status

Last Update Posted

Mar 20, 2008Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Brain Injury
Acute Lung Injury

Interventions

PEEP
PEEP
PEEP
PEEP

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
No financial support

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Dec 2008Estimated

Completion Date

Dec 2008Estimated

First Submitted Date

Mar 12, 2008

First Submission Date that Met QC Criteria

Mar 12, 2008

First Posted Date

Mar 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2008

Last Update Posted Date

Mar 20, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	Patients without lung injury and brain injury	Other: PEEP
Brain No ALI 1	Experimental	Patients with brain injury and no lung injury within 72 hours from ICU entry	Other: PEEP
Brain No ALI 2	Experimental	Patients with brain injury and no ALI after 72 hours from ICU entry	Other: PEEP
Brain ALI	Experimental	Patients with brain injury and Acute Lung Injury (ALI)	Other: PEEP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEEP	Other	Application of positive end expiratory pressure	Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of respiratory function with PEEP		30 min

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paolo Pelosi, MD	Contact	0039-0332-278801		ppelosi@hotmail.com

Overall Officials

Name	Affiliation	Role
Paolo Pelosi, MD	University of Insubria, Varese	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale di Circolo e Fondazione Macchi	Recruiting	Varese	Varese	21100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D001930	Brain Injuries
D055371	Acute Lung Injury

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma

Browse Leaves

Not provided

Browse Branches

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