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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

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00606788
Enrollment
60
Registered
2008-02-05
Start date
2005-11-30
Completion date
2007-02-28
Last updated
2008-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Digestive System Diseases, Musculoskeletal Diseases, Neoplasms, Respiratory Tract 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

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.

Interventions

DEVICESmartCare/PS (Automated Weaning)

Patients received computer-driven protocolized weaning

Patients received physician-directed non-protocolized weaning

Sponsors

University of Luebeck
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
weaning durationmeasured in days

Secondary

MeasureTime frame
reintubation rateexpressed as a percentage

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026