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This bicentric, randomized, controlled trial examines the effectiveness of an automatic control of pressure support ventilation (SmartCare/PS) in critically ill patients.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmartCare/PS | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Total ventilation time during intensive care unit stay. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in the zone of respiratory comfort during invasive mechanical ventilation | ||
| Number of ventilator alarms during invasive mechanical ventilation | ||
| Number of ventilator manipulations during invasive mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Scholz, M.D. | University Medical Centre Schleswig-Holstein, Campus Kiel, Department of Anaesthesiology and Intensive Care Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology and Intensive Care Medicine | Kiel | 24105 | Germany | |||
| Department of Cardiovascular Surgery |
| 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. | |
| 1484275 |
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| Length of ICU and hospital stay |
| 28-day and 90-day mortality |
| Kiel |
| 24105 |
| Germany |
| Dojat M, Brochard L, Lemaire F, Harf A. A knowledge-based system for assisted ventilation of patients in intensive care units. Int J Clin Monit Comput. 1992 Dec;9(4):239-50. doi: 10.1007/BF01133619. |
| 22268137 | Derived | Schadler D, Engel C, Elke G, Pulletz S, Haake N, Frerichs I, Zick G, Scholz J, Weiler N. Automatic control of pressure support for ventilator weaning in surgical intensive care patients. Am J Respir Crit Care Med. 2012 Mar 15;185(6):637-44. doi: 10.1164/rccm.201106-1127OC. Epub 2012 Jan 20. |