Therapy Study of Automated Protocolized vs. Physician-Directed Non-Protocolized Weaning
Primary Purpose
Neoplasms, Musculoskeletal Diseases, Digestive System Diseases
Status
Suspended
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
SmartCare/PS (Automated Weaning)
Conventional weaning
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasms focused on measuring randomized clinical trials, intensive care, mechanical ventilation, ventilator weaning, clinical protocols, therapy, computer-assisted, humans, various surgical diseases requiring mechanical ventilation over 24 hours
Eligibility 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
Sites / Locations
- UKSH Campus Luebeck, Department of Surgery and Surgical Intensive Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
AW
CW
Arm Description
Patients received computer-driven protocolized weaning (= Automated Weaning)
Patients received physician-directed non-protocolized weaning (= Conventional Weaning)
Outcomes
Primary Outcome Measures
weaning duration
Secondary Outcome Measures
reintubation rate
Full Information
NCT ID
NCT00606788
First Posted
January 16, 2008
Last Updated
February 12, 2008
Sponsor
University of Luebeck
1. Study Identification
Unique Protocol Identification Number
NCT00606788
Brief Title
Therapy Study of Automated Protocolized vs. Physician-Directed Non-Protocolized Weaning
Official Title
Comparison of Computer-Driven Protocolized Weaning With Physician-Directed Weaning in Surgical Intensive Care Unit (ICU) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Suspended
Why Stopped
Interim analysis indicated that sample size of study patients had to be highly increased to obtain significant outcomes.
Study Start Date
November 2005 (undefined)
Primary Completion Date
January 2007 (Anticipated)
Study Completion Date
February 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Luebeck
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Musculoskeletal Diseases, Digestive System Diseases, Respiratory Tract Diseases, Cardiovascular Diseases
Keywords
randomized clinical trials, intensive care, mechanical ventilation, ventilator weaning, clinical protocols, therapy, computer-assisted, humans, various surgical diseases requiring mechanical ventilation over 24 hours
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AW
Arm Type
Active Comparator
Arm Description
Patients received computer-driven protocolized weaning (= Automated Weaning)
Arm Title
CW
Arm Type
Active Comparator
Arm Description
Patients received physician-directed non-protocolized weaning (= Conventional Weaning)
Intervention Type
Device
Intervention Name(s)
SmartCare/PS (Automated Weaning)
Other Intervention Name(s)
SmartCare/PS (Draeger Medical AG & Co. KG, Luebeck, Germany)
Intervention Description
Patients received computer-driven protocolized weaning
Intervention Type
Procedure
Intervention Name(s)
Conventional weaning
Intervention Description
Patients received physician-directed non-protocolized weaning
Primary Outcome Measure Information:
Title
weaning duration
Time Frame
measured in days
Secondary Outcome Measure Information:
Title
reintubation rate
Time Frame
expressed as a percentage
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elke Muhl, Prof. Dr. med.
Organizational Affiliation
University of Luebeck
Official's Role
Principal Investigator
Facility Information:
Facility Name
UKSH Campus Luebeck, Department of Surgery and Surgical Intensive Care
City
Luebeck
State/Province
SH
ZIP/Postal Code
23538
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
16840741
Citation
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.
Results Reference
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Therapy Study of Automated Protocolized vs. Physician-Directed Non-Protocolized Weaning
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