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

U

University Hospital Schleswig-Holstein (UKSH)

Status

Completed

Conditions

Ventilator Weaning

Treatments

Device: SmartCare/PS

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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