Respiratory Mechanics in Brain Injured Patients

Not Applicable

• Conditions: Brain Injury; Acute Lung Injury
• Interventions: Other: PEEP

• Registration Number: NCT00639990
• Lead Sponsor: Università degli Studi dell'Insubria

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.

Study Timeline

• Study Start: 2007-06
• Status Verified: 2008-03
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-12
• Last Update Submitted: 2008-03-12
• Study First Posted: 2008-03-20
• Last Update Posted: 2008-03-20
• Primary Completion: 2008-12
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Brain No ALI 1	PEEP	Patients with brain injury and no lung injury within 72 hours from ICU entry
Control	PEEP	Patients without lung injury and brain injury
Brain No ALI 2	PEEP	Patients with brain injury and no ALI after 72 hours from ICU entry
Brain ALI	PEEP	Patients with brain injury and Acute Lung Injury (ALI)

Primary Outcome Measures

Name	Time	Method
Improvement of respiratory function with PEEP	30 min

Secondary Outcome Measures

Name	Time	Method
Relations of respiratory mechanics (lung and chest wall) with intraabdominal pressure	30 min

Trial Locations

Locations (1)

Ospedale di Circolo e Fondazione Macchi; 🇮🇹 Varese, Italy