Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units

Not Applicable

Completed

• Conditions: Ventilator Weaning

• Registration Number: NCT00445289
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

This bicentric, randomized, controlled trial examines the effectiveness of an automatic control of pressure support ventilation (SmartCare/PS) in critically ill patients.

Detailed Description

During the weaning process vigilance, pulmonary mechanics and respiratory drive of the patient are changing. Consequently, ventilation settings have to be modified very often. The modifications can be conducted either according to a weaning protocol or automatically by an expert system (SmartCare/PS). This trial compares protocol-guided weaning with automatic weaning in post-surgical patients and examines the effect on total ventilation time, numbers of manipulations and alarms of the ventilator, length of stay in the ICU and in the hospital, 28- and 90-day mortality.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-07
• Study First Submitted QC: 2007-03-07
• Study First Posted: 2007-03-08
• Status Verified: 2008-08
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Last Update Submitted: 2008-08-15
• Last Update Posted: 2008-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Intubated or tracheotomised patients requiring mechanical ventilation at 9:00 am for longer than 9 hours (within this time period invasive and non-invasive ventilation is permitted)

Exclusion Criteria

• Cerebral trauma / surgery
• Age < 18 years
• Do-not-resuscitate-order
• Duration of mechanical ventilation > 24 h
• Patient is currently participating in this trial (including 90 days follow-up period)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total ventilation time during intensive care unit stay.

Secondary Outcome Measures

Name	Time	Method
Length of ICU and hospital stay
Time in the zone of respiratory comfort during invasive mechanical ventilation
Number of ventilator manipulations during invasive mechanical ventilation
Number of ventilator alarms during invasive mechanical ventilation
28-day and 90-day mortality

Trial Locations

Locations (2)

Department of Anaesthesiology and Intensive Care Medicine; 🇩🇪 Kiel, Germany

Department of Cardiovascular Surgery; 🇩🇪 Kiel, Germany