Therapy Study of Automated Protocolized vs. Physician-Directed Non-Protocolized Weaning

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. Identifier: NCT00606788
Recruitment Status : Suspended (Interim analysis indicated that sample size of study patients had to be highly increased to obtain significant outcomes.)
First Posted : February 5, 2008
Last Update Posted : February 18, 2008
Information provided by:
University of Luebeck

Brief Summary:
The purpose of this study was to determine whether computer-driven protocolized weaning is superior to physician-directed non-protocolized weaning in over-24-hours-ventilated surgical intensive care unit (ICU) patients. The main hypothesis was that weaning duration differs between both methods. Secondary hypotheses were that reintubation rate, duration of mechanical ventilation, intensive care unit (ICU) length of stay and workload for physicians and nurses differ between both methods.

Condition or disease Intervention/treatment Phase
Neoplasms Musculoskeletal Diseases Digestive System Diseases Respiratory Tract Diseases Cardiovascular Diseases Device: SmartCare/PS (Automated Weaning) Procedure: Conventional weaning Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Computer-Driven Protocolized Weaning With Physician-Directed Weaning in Surgical Intensive Care Unit (ICU) Patients
Study Start Date : November 2005
Estimated Primary Completion Date : January 2007
Estimated Study Completion Date : February 2007

Arm Intervention/treatment
Active Comparator: AW
Patients received computer-driven protocolized weaning (= Automated Weaning)
Device: SmartCare/PS (Automated Weaning)
Patients received computer-driven protocolized weaning
Other Name: SmartCare/PS (Draeger Medical AG & Co. KG, Luebeck, Germany)
Active Comparator: CW
Patients received physician-directed non-protocolized weaning (= Conventional Weaning)
Procedure: Conventional weaning
Patients received physician-directed non-protocolized weaning

Primary Outcome Measures :
  1. weaning duration [ Time Frame: measured in days ]

Secondary Outcome Measures :
  1. reintubation rate [ Time Frame: expressed as a percentage ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00606788

UKSH Campus Luebeck, Department of Surgery and Surgical Intensive Care
Luebeck, SH, Germany, 23538
Sponsors and Collaborators
University of Luebeck
Principal Investigator: Elke Muhl, Prof. Dr. med. University of Luebeck

Responsible Party: Prof. Dr. med. Elke Muhl, Department of Surgery and Surgical Intensive Care Identifier: NCT00606788     History of Changes
Other Study ID Numbers: Luebeck 0001
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: February 18, 2008
Last Verified: January 2008

Keywords provided by University of Luebeck:
randomized clinical trials
intensive care
mechanical ventilation
ventilator weaning
clinical protocols
therapy, computer-assisted
various surgical diseases requiring mechanical ventilation over 24 hours

Additional relevant MeSH terms:
Cardiovascular Diseases
Musculoskeletal Diseases
Respiratory Tract Diseases
Digestive System Diseases
Gastrointestinal Diseases