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Comparison of Computer-Driven Protocolized Weaning With Physician-Directed Weaning in Surgical Intensive Care Unit (ICU) Patients

18 Years
80 Years
Not Enrolling
Neoplasms, Musculoskeletal Diseases, Digestive System Diseases, Respiratory Tract Diseases, Cardiovascular Diseases

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Trial Information

Comparison of Computer-Driven Protocolized Weaning With Physician-Directed Weaning in Surgical Intensive Care Unit (ICU) Patients

Since long-term mechanical ventilation is affiliated with a bunch of complications, weaning
affected patients from ventilation as soon as possible is a crucial point. In this context
automated computerized systems have become a torchbearer. These systems are expected to
expedite the weaning process, reduce the duration of mechanical ventilation and ICU length
of stay of a given patient in comparison to conventional physician-directed weaning. A
multicenter randomized trial by Lellouche et al supported these theories, using a
computer-driven system to regulate Pressure Support Ventilation (PSV). This system is now
commercially available as SmartCare/PS (Draeger Medical AG & Co. KG, Luebeck, Germany).

The purpose of the study on hand was to find out whether the results reported before could
be repeated in a broad, surgical ICU patient group. Study design was chosen similar. In
addition we investigated the workload for physicians and nurses in both study arms which has
not been conducted before.

Inclusion Criteria:

- mechanical ventilation > 24 hours

- intubation OR tracheostomy

- informed consent

- 35 - 200 kg bodyweight (77,2 - 440,9 lb)

- Ramsay-Score < 3

- spontaneous breathing at a PEEP of < 10 cm H2O

- sufficient arterial oxygenation (paO2 > 55 mmHg or SaO2 > 90%)

- haemodynamic stability (< 5 µg/kg/min Dopamine)

- body temperature (rectal) max. 39 °C / 102.2 °F

- hemoglobin > 7 g/dl

- pH > 7,2

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

weaning duration

Outcome Time Frame:

measured in days

Safety Issue:


Principal Investigator

Elke Muhl, Prof. Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Luebeck


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

Luebeck 0001



Start Date:

November 2005

Completion Date:

February 2007

Related Keywords:

  • Neoplasms
  • Musculoskeletal Diseases
  • Digestive System Diseases
  • Respiratory Tract Diseases
  • Cardiovascular Diseases
  • randomized clinical trials
  • intensive care
  • mechanical ventilation
  • ventilator weaning
  • clinical protocols
  • therapy, computer-assisted
  • humans
  • various surgical diseases requiring mechanical ventilation over 24 hours
  • Neoplasms
  • Cardiovascular Diseases
  • Digestive System Diseases
  • Gastrointestinal Diseases
  • Musculoskeletal Diseases
  • Respiratory Tract Diseases