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Interim analysis indicated that sample size of study patients had to be highly increased to obtain significant outcomes.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AW | Active Comparator | Patients received computer-driven protocolized weaning (= Automated Weaning) |
|
| CW | Active Comparator | Patients received physician-directed non-protocolized weaning (= Conventional Weaning) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmartCare/PS (Automated Weaning) | Device | Patients received computer-driven protocolized weaning |
|
| Measure | Description | Time Frame |
|---|---|---|
| weaning duration | measured in days |
| Measure | Description | Time Frame |
|---|---|---|
| reintubation rate | expressed as a percentage |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elke Muhl, Prof. Dr. med. | University of Luebeck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UKSH Campus Luebeck, Department of Surgery and Surgical Intensive Care | Lübeck | Schleswig-Holstein | 23538 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16840741 | Background | Lellouche F, Mancebo J, Jolliet P, Roeseler J, Schortgen F, Dojat M, Cabello B, Bouadma L, Rodriguez P, Maggiore S, Reynaert M, Mersmann S, Brochard L. A multicenter randomized trial of computer-driven protocolized weaning from mechanical ventilation. Am J Respir Crit Care Med. 2006 Oct 15;174(8):894-900. doi: 10.1164/rccm.200511-1780OC. Epub 2006 Jul 13. |
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| Conventional weaning | Procedure | Patients received physician-directed non-protocolized weaning |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009140 | Musculoskeletal Diseases |
| D004066 | Digestive System Diseases |
| D012140 | Respiratory Tract Diseases |
| D002318 | Cardiovascular Diseases |
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