NCT03249623

Individualised Weaning From Mechanical Ventilation in General ICU

Weaning From Mechanical Ventilation: Comparison of Open-Loop Decision Support System and Routine Care, in the General Intensive Care Unit

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 274 (estimated)
• Sponsor: Chelsea and Westminster NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ventilatory Failure

Interventions

Type	Name	Description
DEVICE	Beacon Caresystem	The core of the system is a set of physiological models including pulmonary gas exchange, acid-base chemistry, lung mechanics, and respiratory drive. The Beacon Caresystem tunes these models to the individual patient such that they describe accurately current measurements. Once tuned, the models are used by the system to simulate the effects of changing ventilator settings. The results of these simulations are then used calculate the clinical benefit of changing ventilator settings by balancing the competing goals of mechanical ventilation.

Timeline

• Start date: 2017-12-11
• Primary completion: 2020-11-30
• Completion: 2021-07-30
• First posted: 2017-08-15
• Last updated: 2020-07-21

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study