Clinical trial NCT00445289: Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units
Official title: Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units - a Bicentric, Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Weaning
Keywords: mechanical ventilation
ventilator weaning
closed-loop
ventilation time
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2007-03-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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)

Primary outcomes:
measure: Total ventilation time during intensive care unit stay.
Secondary outcomes:
measure: Time in the zone of respiratory comfort during invasive mechanical ventilation
measure: Number of ventilator alarms during invasive mechanical ventilation
measure: Number of ventilator manipulations during invasive mechanical ventilation
measure: Length of ICU and hospital stay
measure: 28-day and 90-day mortality
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Department of Anaesthesiology and Intensive Care Medicine
city: Kiel
country: Germany
facility: Department of Cardiovascular Surgery
Study officials:
affiliation: University Medical Centre Schleswig-Holstein, Campus Kiel, Department of Anaesthesiology and Intensive Care Medicine
name: Jens Scholz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1164/rccm.200511-1780OC. Epub 2006 Jul 13.
citation: 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. doi: 10.1007/BF01133619.
citation: Schadler D, Engel C, Elke G, Pulletz S, Haake N, Frerichs I, Zick G, Scholz J, Weiler N. Automatic control of pressure support for ventilator weaning in surgical intensive care patients. Am J Respir Crit Care Med. 2012 Mar 15;185(6):637-44. doi: 10.1164/rccm.201106-1127OC. Epub 2012 Jan 20.