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Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units (ASOPI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00445289
First Posted: March 8, 2007
Last Update Posted: August 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Schleswig-Holstein
  Purpose
This bicentric, randomized, controlled trial examines the effectiveness of an automatic control of pressure support ventilation (SmartCare/PS) in critically ill patients.

Condition Intervention
Ventilator Weaning Device: SmartCare/PS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units - a Bicentric, Prospective, Randomized, Controlled Trial

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Total ventilation time during intensive care unit stay.

Secondary Outcome Measures:
  • 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

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)
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445289


Locations
Germany
Department of Anaesthesiology and Intensive Care Medicine
Kiel, Germany, 24105
Department of Cardiovascular Surgery
Kiel, Germany, 24105
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: Jens Scholz, M.D. University Medical Centre Schleswig-Holstein, Campus Kiel, Department of Anaesthesiology and Intensive Care Medicine