NCT00639990

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 20, 2008

Status Verified

March 1, 2008

Enrollment Period

1.5 years

First QC Date

March 12, 2008

Last Update Submit

March 12, 2008

Conditions

Brain InjuryAcute Lung Injury

Keywords

Intraabdominal pressure

Outcome Measures

Primary Outcomes (1)

  • Improvement of respiratory function with PEEP

    30 min

Secondary Outcomes (1)

  • Relations of respiratory mechanics (lung and chest wall) with intraabdominal pressure

    30 min

Study Arms (4)

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

PEEPOTHER

Application of positive end expiratory pressure

Also known as: No brain injury No ALI
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Hemodynamic instability
  • Immunodepression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale di Circolo e Fondazione Macchi

Varese, Varese, 21100, Italy

RECRUITING

MeSH Terms

Conditions

Brain InjuriesAcute Lung Injury

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesLung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Paolo Pelosi, MD

    University of Insubria, Varese

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Pelosi, MD

CONTACT

0039-0332-278801ppelosi@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 20, 2008

Study Start

June 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

March 20, 2008

Record last verified: 2008-03

Locations

IT(1)