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Completed

NCT Number: NCT00445289

Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units

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

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Key information

Conditions

Ventilator Weaning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Intensive Care Medicine, Kiel, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Smartcare/PS

Device

Primary outcomes

  1. Total ventilation time during intensive care unit stay.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units - a Bicentric, Prospective, Randomized, Controlled Trial

Acronym: ASOPI

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 8, 2007
Registry last updated
Aug 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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