Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units

Ventilator Weaning Clinical Trial

— ASOPI  

Official title:

Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units - a Bicentric, Prospective, Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445289
• Other study ID #: ASOPI
• Status: Completed
• Phase: N/A
• First received: March 7, 2007
• Last updated: August 15, 2008
• Start date: March 2007
• Est. completion date: August 2008

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ventilator Weaning

Intervention

Device:
• SmartCare/PS

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology and Intensive Care Medicine	Kiel
Germany	Department of Cardiovascular Surgery	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. Epub 2006 Jul 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total ventilation time during intensive care unit stay.
Secondary	Time in the zone of respiratory comfort during invasive mechanical ventilation
Secondary	Number of ventilator alarms during invasive mechanical ventilation
Secondary	Number of ventilator manipulations during invasive mechanical ventilation
Secondary	Length of ICU and hospital stay
Secondary	28-day and 90-day mortality