Clinical trial NCT00606788: 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
Overall status: SUSPENDED
Phase: NA
Conditions: 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
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2008-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: weaning duration
timeFrame: measured in days
Secondary outcomes:
measure: reintubation rate
timeFrame: expressed as a percentage
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: UKSH Campus Luebeck, Department of Surgery and Surgical Intensive Care
state: SH
Study officials:
affiliation: University of Luebeck
name: Elke Muhl, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
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.