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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00445289
Other study ID # ASOPI
Secondary ID
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


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
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