Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Interim analysis indicated that sample size of study patients had to be highly increased to obtain significant outcomes.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Digestive System Diseases | — | UNRESOLVED | — |
| Musculoskeletal Diseases | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Respiratory Tract Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional weaning | Procedure | — | UNRESOLVED |
| SmartCare/PS (Automated Weaning) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- AW
- description
- Patients received computer-driven protocolized weaning (= Automated Weaning)
- interventionNames
- Device: SmartCare/PS (Automated Weaning)
- type
- ACTIVE_COMPARATOR
- label
- CW
- description
- Patients received physician-directed non-protocolized weaning (= Conventional Weaning)
- interventionNames
- Procedure: Conventional weaning
Primary outcomes (1)
- measure
- weaning duration
- timeFrame
- measured in days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDLellouche 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 16840741