Evaluation of Variable Pressure Support Ventilation in the Therapy of Acute Lung Injury

Not Applicable

Completed

• Conditions: Acute Lung Injury
• Interventions: Other: Assisted mechanical ventilation

• Registration Number: NCT00786292
• Lead Sponsor: Technische Universität Dresden

Brief Summary

Variable pressure support during assisted spontaneous breathing (noisy PSV) has been shown to improve the respiratory function in experimental acute lung injury (ALI). We aimed at comparing the effects of noisy PSV with traditional PSV on the respiratory function of patients suffering from ALI.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-05
• Study First Posted: 2008-11-06
• Status Verified: 2009-07
• Study Start: 2009-07
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-03
• Last Update Posted: 2012-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• age 18 to 75 yrs
• 150 mmHg < PaO2/FIO2 < 300 mmHg
• mechanical ventilation with PSV or BIPAP
• less than 15 days of mechanical ventilation
• at least 20% of minute ventilation originated from spontaneous breathing

Exclusion Criteria

• BMI > 35
• esophageal disease
• neuromuscular disease
• instable thorax
• pneumothorax
• head trauma
• brain injury
• increased intracranial pressure
• agitation
• increased need for vasoactive drugs
• chronic lung disease
• acute coronary disease
• participation in another clinical trial within the last 4 weeks at enrollment

Interruption criteria:

• acute change of mental status
• SaO2 < 92%
• pHa < 7.30
• respiratory rate > 30 or < 6 /min
• dyspnea
• diaphragm/thorax antagonism
• diaphoresis
• abnormal use of respiratory muscles
• increase of the heart rate above 120% of baseline or absolute value < 60 or > 130 /min
• mean arterial pressure above 120% of baseline or absolute value < 70 or > 110 mmHg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Noisy PSV	Assisted mechanical ventilation	Assisted mechanical ventilation with noisy PSV
PSV	Assisted mechanical ventilation	Assisted mechanical ventilation with PSV

Primary Outcome Measures

Name	Time	Method
Effect on the arterial oxygenation

Secondary Outcome Measures

Name	Time	Method
Effect on the work of breathing
Effect on PaCO2

Trial Locations

Locations (1)

University Clinic Carl Gustav Carus, Technical University Dresden; 🇩🇪 Dresden, Germany