Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Ventilator Weaning

Keywords

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mechanical ventilation ventilator weaning closed-loop ventilation time

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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SmartCare/PS

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jens Scholz, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Anaesthesiology and Intensive Care Medicine

Kiel, , Germany

Site Status

Department of Cardiovascular Surgery

Kiel, , Germany

Site Status

Countries

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Germany

References

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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)

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.

Reference Type BACKGROUND

PMID: 1484275 (View on PubMed)

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.

Reference Type DERIVED

PMID: 22268137 (View on PubMed)

Other Identifiers

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ASOPI

Identifier Type: -

Identifier Source: org_study_id