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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00606788
• Other study ID #: Luebeck 0001
• Status: Suspended
• Phase: N/A
• First received: January 16, 2008
• Last updated: February 12, 2008
• Start date: November 2005
• Est. completion date: February 2007

Study information

• Verified date: January 2008
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: February 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Digestive System Diseases
• Gastrointestinal Diseases
• Musculoskeletal Diseases
• Neoplasms
• Respiratory Tract Diseases

Intervention

Device:
• SmartCare/PS (Automated Weaning)
Patients received computer-driven protocolized weaning

Procedure:
• Conventional weaning
Patients received physician-directed non-protocolized weaning

Locations

Country	Name	City	State
Germany	UKSH Campus Luebeck, Department of Surgery and Surgical Intensive Care	Luebeck	SH

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. Epub 2006 Jul 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weaning duration		measured in days	No
Secondary	reintubation rate		expressed as a percentage	Yes