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

Sponsored by:	University of Luebeck
Information provided by:	University of Luebeck
ClinicalTrials.gov Identifier:	NCT00606788

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

MedlinePlus related topics: Cancer Digestive Diseases

U.S. FDA Resources

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

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
AW: Active Comparator Patients received computer-driven protocolized weaning (= Automated Weaning)	Device: SmartCare/PS (Automated Weaning) Patients received computer-driven protocolized weaning
CW: Active Comparator 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, SH
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:

Lellouche F, Mancebo J, Jolliet P, Roeseler J, Schortgen F, Dojat M, Cabello B, Bouadma L, Rodriguez P, Maggiore S, Reynaert M, Mersmann S, Brochard L. A multicenter randomized trial of computer-driven protocolized weaning from mechanical ventilation. Am J Respir Crit Care Med. 2006 Oct 15;174(8):894-900. Epub 2006 Jul 13.

Responsible Party:	Department of Surgery and Surgical Intensive Care ( Prof. Dr. med. Elke Muhl )
Study ID Numbers:	Luebeck 0001
Study First Received:	January 16, 2008
Last Updated:	February 12, 2008
ClinicalTrials.gov Identifier:	NCT00606788
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

Study placed in the following topic categories:

Digestive System Diseases
Respiratory Tract Diseases
Musculoskeletal Diseases

Additional relevant MeSH terms:

Neoplasms
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009