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NCT00639990 Clinical Trial

Respiratory Mechanics in Brain Injured Patients

Acute Lung Injury Clinical Trial

Official title:
Effects of PEEP in Brain Injury Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00639990
Other study ID # 003
Secondary ID No financial sup
Status Recruiting
Phase N/A
First received March 12, 2008
Last updated March 12, 2008
Start date June 2007
Est. completion date December 2008

Study information
Verified date March 2008
Source Università degli Studi dell'Insubria
Contact Paolo Pelosi, MD
Phone 0039-0332-278801
Email ppelosi@hotmail.com
Is FDA regulated No
Health authority Italy: National Institute of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• PEEP
Application of positive end expiratory pressure
• PEEP
Application of positive end-expiratory pressure
• PEEP
Application of positive end-expiratory pressure
• PEEP
Application of positive end-expiratory pressure

Locations
Country Name City State
Italy Ospedale di Circolo e Fondazione Macchi Varese

Sponsors (1)
Lead Sponsor Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement of respiratory function with PEEP 30 min No
Secondary Relations of respiratory mechanics (lung and chest wall) with intraabdominal pressure 30 min No
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