Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00445289

Acronym

ASOPI

Enrollment

300

Registered

2007-03-08

Start date

2007-03-31

Completion date

2008-08-31

Last updated

2008-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Weaning

Keywords

mechanical ventilation, ventilator weaning, closed-loop, ventilation time

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.

Interventions

DEVICESmartCare/PS

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Total ventilation time during intensive care unit stay.	—

Secondary

Measure	Time frame
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	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026