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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: SmartCare/PS (Automated Weaning)
* Procedure: Conventional weaning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AW<br>Patients received computer-driven protocolized weaning (= Automated Weaning) | Device: SmartCare/PS (Automated Weaning)<br>* Patients received computer-driven protocolized weaning<br>* Other names: SmartCare/PS (Draeger Medical AG & Co. KG, Luebeck, Germany);|
| Active Comparator: CW<br>Patients received physician-directed non-protocolized weaning (= Conventional Weaning) | Procedure: Conventional weaning<br>* Patients received physician-directed non-protocolized weaning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weaning duration |  | measured in days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reintubation rate |  | expressed as a percentage | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized clinical trials, intensive care, mechanical ventilation, ventilator weaning, clinical protocols, therapy, computer-assisted, humans, various surgical diseases requiring mechanical ventilation over 24 hours