Study Stopped
Interim analysis indicated that sample size of study patients had to be highly increased to obtain significant outcomes.
Therapy Study of Automated Protocolized vs. Physician-Directed Non-Protocolized Weaning
Comparison of Computer-Driven Protocolized Weaning With Physician-Directed Weaning in Surgical Intensive Care Unit (ICU) Patients
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 16, 2008
CompletedFirst Posted
Study publicly available on registry
February 5, 2008
CompletedFebruary 18, 2008
January 1, 2008
1.2 years
January 16, 2008
February 12, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
weaning duration
measured in days
Secondary Outcomes (1)
reintubation rate
expressed as a percentage
Study Arms (2)
AW
ACTIVE COMPARATORPatients received computer-driven protocolized weaning (= Automated Weaning)
CW
ACTIVE COMPARATORPatients received physician-directed non-protocolized weaning (= Conventional Weaning)
Interventions
Patients received computer-driven protocolized weaning
Eligibility Criteria
You may qualify if:
- mechanical ventilation \> 24 hours
- intubation OR tracheostomy
- informed consent
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UKSH Campus Luebeck, Department of Surgery and Surgical Intensive Care
Lübeck, Schleswig-Holstein, 23538, Germany
Related Publications (1)
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. doi: 10.1164/rccm.200511-1780OC. Epub 2006 Jul 13.
PMID: 16840741BACKGROUND
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Elke Muhl, Prof. Dr. med.
University of Luebeck
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 16, 2008
First Posted
February 5, 2008
Study Start
November 1, 2005
Primary Completion
January 1, 2007
Study Completion
February 1, 2007
Last Updated
February 18, 2008
Record last verified: 2008-01