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

February 12, 2008 updated by: University of Luebeck

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • SH
      • Luebeck, SH, Germany, 23538
        • UKSH Campus Luebeck, Department of Surgery and Surgical Intensive Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weaning duration
Time Frame: measured in days
measured in days

Secondary Outcome Measures

Outcome Measure
Time Frame
reintubation rate
Time Frame: expressed as a percentage
expressed as a percentage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Investigators

  • Principal Investigator: Elke Muhl, Prof. Dr. med., University of Luebeck

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Anticipated)

January 1, 2007

Study Completion (Anticipated)

February 1, 2007

Study Registration Dates

First Submitted

January 16, 2008

First Submitted That Met QC Criteria

January 22, 2008

First Posted (Estimate)

February 5, 2008

Study Record Updates

Last Update Posted (Estimate)

February 18, 2008

Last Update Submitted That Met QC Criteria

February 12, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Luebeck 0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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