Ventilatory Failure Clinical Trial
Official title:
Weaning From Mechanical Ventilation: Comparison of Open‐Loop Decision Support System and Routine Care, in the General Intensive Care Unit
Patients residing in the intensive care unit typically receive mechanical ventilatory
support. Selecting the appropriate level of mechanical ventilation is not trivial, and it has
been shown that lung protective settings can reduce mortality in patients with lung injury.
Despite being a life- saving therapy, duration of mechanical ventilation should be kept at a
minimum to reduce effects of immobilization, long-term sedation, patient discomfort, risk of
ventilator associated pneumonia, leading to decreasing mortality and economic costs etc. The
duration of mechanical ventilation is also an important factor in weaning from ventilatory
support, with prolonged ventilator support making the weaning process more difficult.
The purpose of this study is to compare mechanical ventilation following advice from the
Beacon Caresystem to that of standard care in general medical intensive care unit (ICU)
patients, from the start of requiring invasive mechanical ventilation until successful
extubation. The Beacon Caresystem will be compared to standard care to investigate whether
use of the system results in similar care or reduced time for weaning from mechanical
ventilation.
All patients admitted to the ICU with mechanical ventilation are screened for inclusion.
Patients receiving invasive mechanical ventilation (≥ 24 h) will be considered for inclusion
in the study on a daily basis. Patient screening will be performed by clinical researchers or
a delegated clinician and consent/assent will be sought. Then patients will be randomised to
the Beacon group or Standard Care group. Randomisation will be performed using sealed
envelopes, and in blocks of patients, allowing interim analysis of results in appropriate
steps during the study. To avoid that results are affected by patient disease type,
randomisation will be stratified for equal distribution between randomisation groups.
Patients will be randomly assigned to either standard care of mechanical ventilation, or to
follow the advice of the Beacon Caresystem. The results of these two strategies will then be
compared based upon the following outcome measurements.
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