NCT00606788

Therapy Study of Automated Protocolized vs. Physician-Directed Non-Protocolized Weaning

Comparison of Computer-Driven Protocolized Weaning With Physician-Directed Weaning in Surgical Intensive Care Unit (ICU) Patients

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Luebeck · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to determine whether computer-driven protocolized weaning is superior to physician-directed non-protocolized weaning in over-24-hours-ventilated surgical intensive care unit (ICU) patients. The main hypothesis was that weaning duration differs between both methods. Secondary hypotheses were that reintubation rate, duration of mechanical ventilation, intensive care unit (ICU) length of stay and workload for physicians and nurses differ between both methods.

Detailed description

Since long-term mechanical ventilation is affiliated with a bunch of complications, weaning affected patients from ventilation as soon as possible is a crucial point. In this context automated computerized systems have become a torchbearer. These systems are expected to expedite the weaning process, reduce the duration of mechanical ventilation and ICU length of stay of a given patient in comparison to conventional physician-directed weaning. A multicenter randomized trial by Lellouche et al supported these theories, using a computer-driven system to regulate Pressure Support Ventilation (PSV). This system is now commercially available as SmartCare/PS (Draeger Medical AG \& Co. KG, Luebeck, Germany). The purpose of the study on hand was to find out whether the results reported before could be repeated in a broad, surgical ICU patient group. Study design was chosen similar. In addition we investigated the workload for physicians and nurses in both study arms which has not been conducted before.

Conditions

• Neoplasms
• Musculoskeletal Diseases
• Digestive System Diseases
• Respiratory Tract Diseases
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	SmartCare/PS (Automated Weaning)	Patients received computer-driven protocolized weaning
PROCEDURE	Conventional weaning	Patients received physician-directed non-protocolized weaning

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-01-01
• Completion: 2007-02-01
• First posted: 2008-02-05
• Last updated: 2008-02-18

Locations

1 site across 1 country: Germany