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

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ClinicalTrials.gov Identifier: NCT00445289
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : August 18, 2008
Sponsor:
Information provided by:
University of Schleswig-Holstein

Brief Summary:
This bicentric, randomized, controlled trial examines the effectiveness of an automatic control of pressure support ventilation (SmartCare/PS) in critically ill patients.

Condition or disease Intervention/treatment Phase
Ventilator Weaning Device: SmartCare/PS Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Study Start Date : March 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008



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

Secondary Outcome Measures :
  1. Time in the zone of respiratory comfort during invasive mechanical ventilation
  2. Number of ventilator alarms during invasive mechanical ventilation
  3. Number of ventilator manipulations during invasive mechanical ventilation
  4. Length of ICU and hospital stay
  5. 28-day and 90-day mortality


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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)

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