Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units
ASOPI
1 other identifier
interventional
300
1 country
2
Brief Summary
This bicentric, randomized, controlled trial examines the effectiveness of an automatic control of pressure support ventilation (SmartCare/PS) in critically ill patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2007
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 7, 2007
CompletedFirst Posted
Study publicly available on registry
March 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedAugust 18, 2008
August 1, 2008
1.4 years
March 7, 2007
August 15, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total ventilation time during intensive care unit stay.
Secondary Outcomes (5)
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
Length of ICU and hospital stay
28-day and 90-day mortality
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Anaesthesiology and Intensive Care Medicine
Kiel, 24105, Germany
Department of Cardiovascular Surgery
Kiel, 24105, Germany
Related Publications (3)
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.
PMID: 16840741BACKGROUNDDojat 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.
PMID: 1484275BACKGROUNDSchadler 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.
PMID: 22268137DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jens Scholz, M.D.
University Medical Centre Schleswig-Holstein, Campus Kiel, Department of Anaesthesiology and Intensive Care Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 7, 2007
First Posted
March 8, 2007
Study Start
March 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
August 18, 2008
Record last verified: 2008-08