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

NCT ID: NCT00606788

Last Updated: 2008-02-18

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2007-02-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AW

Patients received computer-driven protocolized weaning (= Automated Weaning)

Group Type: ACTIVE_COMPARATOR

SmartCare/PS (Automated Weaning)

Intervention Type: DEVICE

Patients received computer-driven protocolized weaning

CW

Patients received physician-directed non-protocolized weaning (= Conventional Weaning)

Group Type: ACTIVE_COMPARATOR

Conventional weaning

Intervention Type: PROCEDURE

Patients received physician-directed non-protocolized weaning

Interventions

SmartCare/PS (Automated Weaning)

Patients received computer-driven protocolized weaning

Intervention Type: DEVICE

Conventional weaning

Patients received physician-directed non-protocolized weaning

Intervention Type: PROCEDURE

Other Intervention Names

SmartCare/PS (Draeger Medical AG & Co. KG, Luebeck, Germany)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Luebeck

OTHER

Sponsor Role: lead

Responsible Party

Department of Surgery and Surgical Intensive Care

Principal Investigators

Elke Muhl, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Luebeck

Locations

UKSH Campus Luebeck, Department of Surgery and Surgical Intensive Care

Lübeck, Schleswig-Holstein, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 16840741 (View on PubMed)

Other Identifiers

Luebeck 0001

Identifier Type: -

Identifier Source: org_study_id