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Sponsored by: |
University of Schleswig-Holstein |
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Information provided by: | University of Schleswig-Holstein |
ClinicalTrials.gov Identifier: | NCT00445289 |
This bicentric, randomized, controlled trial examines the effectiveness of an automatic control of pressure support ventilation (SmartCare/PS) in critically ill patients.
Condition | Intervention |
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Ventilator Weaning |
Device: SmartCare/PS |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units - a Bicentric, Prospective, Randomized, Controlled Trial |
Estimated Enrollment: | 300 |
Study Start Date: | March 2007 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Department of Anaesthesiology and Intensive Care Medicine | |
Kiel, Germany, 24105 | |
Department of Cardiovascular Surgery | |
Kiel, Germany, 24105 |
Principal Investigator: | Jens Scholz, M.D. | University Medical Centre Schleswig-Holstein, Campus Kiel, Department of Anaesthesiology and Intensive Care Medicine |
Study ID Numbers: | ASOPI |
Study First Received: | March 7, 2007 |
Last Updated: | August 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00445289 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
mechanical ventilation ventilator weaning closed-loop ventilation time |