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

This study has suspended participant recruitment.
(Interim analysis indicated that sample size of study patients had to be highly increased to obtain significant outcomes.)
Sponsor:
Information provided by:
University of Luebeck
ClinicalTrials.gov Identifier:
NCT00606788
First received: January 16, 2008
Last updated: February 12, 2008
Last verified: January 2008
History of Changes
  Purpose

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 Intervention
Neoplasms
Musculoskeletal Diseases
Digestive System Diseases
Respiratory Tract Diseases
Cardiovascular Diseases
 Device: SmartCare/PS (Automated Weaning)
Procedure: Conventional weaning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Computer-Driven Protocolized Weaning With Physician-Directed Weaning in Surgical Intensive Care Unit (ICU) Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • weaning duration [ Time Frame: measured in days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reintubation rate [ Time Frame: expressed as a percentage ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: November 2005
Estimated Study Completion Date: February 2007
Estimated Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606788

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

Publications:

Responsible Party: Prof. Dr. med. Elke Muhl, Department of Surgery and Surgical Intensive Care
ClinicalTrials.gov Identifier: NCT00606788     History of Changes
Other Study ID Numbers: Luebeck 0001
Study First Received: January 16, 2008
Last Updated: February 12, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on June 17, 2013