Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units - Full Text View

Sponsored by:	University of Schleswig-Holstein
Information provided by:	University of Schleswig-Holstein
ClinicalTrials.gov Identifier:	NCT00445289

Purpose

This bicentric, randomized, controlled trial examines the effectiveness of an automatic control of pressure support ventilation (SmartCare/PS) in critically ill patients.

Condition	Intervention
Ventilator Weaning	Device: SmartCare/PS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units - a Bicentric, Prospective, Randomized, Controlled Trial

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:

Total ventilation time during intensive care unit stay.

Secondary Outcome Measures:

Time in the zone of respiratory comfort during invasive mechanical ventilation
Number of ventilator alarms during invasive mechanical ventilation
Number of ventilator manipulations during invasive mechanical ventilation
Length of ICU and hospital stay
28-day and 90-day mortality

Estimated Enrollment:	300
Study Start Date:	March 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Detailed Description:

During the weaning process vigilance, pulmonary mechanics and respiratory drive of the patient are changing. Consequently, ventilation settings have to be modified very often. The modifications can be conducted either according to a weaning protocol or automatically by an expert system (SmartCare/PS). This trial compares protocol-guided weaning with automatic weaning in post-surgical patients and examines the effect on total ventilation time, numbers of manipulations and alarms of the ventilator, length of stay in the ICU and in the hospital, 28- and 90-day mortality.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Intubated or tracheotomised patients requiring mechanical ventilation at 9:00 am for longer than 9 hours (within this time period invasive and non-invasive ventilation is permitted)

Exclusion Criteria:

Cerebral trauma / surgery
Age < 18 years
Do-not-resuscitate-order
Duration of mechanical ventilation > 24 h
Patient is currently participating in this trial (including 90 days follow-up period)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445289

Locations

Germany
Department of Anaesthesiology and Intensive Care Medicine
Kiel, Germany, 24105
Department of Cardiovascular Surgery
Kiel, Germany, 24105

Sponsors and Collaborators

University of Schleswig-Holstein

Investigators

Principal Investigator:

Jens Scholz, M.D.

University Medical Centre Schleswig-Holstein, Campus Kiel, Department of Anaesthesiology and Intensive Care Medicine

More Information

Publications:

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.

Dojat M, Brochard L, Lemaire F, Harf A. A knowledge-based system for assisted ventilation of patients in intensive care units. Int J Clin Monit Comput. 1992 Dec;9(4):239-50.

Study ID Numbers:	ASOPI
Study First Received:	March 7, 2007
Last Updated:	August 15, 2008
ClinicalTrials.gov Identifier:	NCT00445289
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Schleswig-Holstein:

mechanical ventilation
ventilator weaning
closed-loop
ventilation time

ClinicalTrials.gov processed this record on January 16, 2009