Ventilator Weaning Clinical Trial
— ASOPIOfficial title:
Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units - a Bicentric, Prospective, Randomized, Controlled Trial
This bicentric, randomized, controlled trial examines the effectiveness of an automatic control of pressure support ventilation (SmartCare/PS) in critically ill patients.
Status | Completed |
Enrollment | 300 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Department of Anaesthesiology and Intensive Care Medicine | Kiel | |
Germany | Department of Cardiovascular Surgery | Kiel |
Lead Sponsor | Collaborator |
---|---|
University of Schleswig-Holstein |
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. — View Citation
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. Epub 2006 Jul 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total ventilation time during intensive care unit stay. | |||
Secondary | Time in the zone of respiratory comfort during invasive mechanical ventilation | |||
Secondary | Number of ventilator alarms during invasive mechanical ventilation | |||
Secondary | Number of ventilator manipulations during invasive mechanical ventilation | |||
Secondary | Length of ICU and hospital stay | |||
Secondary | 28-day and 90-day mortality |
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