Weaning From Mechanical Ventilation Comparison of Open-loop Decision Support System and Routine Care

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-12

Study Completion Date

2019-09-30

Brief Summary

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The purpose of this study is to compare mechanical ventilation following advice from the Beacon Caresystem to that of routine care in patients from the state of requiring invasive mechanical ventilation until successful extubation. The Beacon Caresystem will be compared to routine care to investigate whether use of the system results in similar care and reduced time for weaning from mechanical ventilation.

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Detailed Description

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Conditions

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Respiration, Artificial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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open loop weaning group (Beacon)

mechanical ventilation following advice from the Beacon Caresystem

Group Type EXPERIMENTAL

open loop weaning group (Beacon)

Intervention Type DEVICE

mechanical ventilation following advice from the Beacon Caresystem

Routine care

* Connect and start Beacon with advice disabled
* Standardized routine care

Group Type ACTIVE_COMPARATOR

Routine care

Intervention Type OTHER

Standardized routine care

Interventions

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open loop weaning group (Beacon)

mechanical ventilation following advice from the Beacon Caresystem

Intervention Type DEVICE

Routine care

Standardized routine care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient is on invasive mechanical ventilation more 48 hours
* Age \> 18 years
* Patients are ventilated using Maquet Servo-I, Draeger Infinity V500 or Draeger Evita XL mechanical ventilators in "pressure support", "volume controlled", or "pressure controlled" ventilation modes.
* Haemodynamically stable (mean blood pressure ≥ 65 mmHg)
* Patients or, in the case that the patient is unable, next of kin understand and accept oral and written information describing the study or patient consent retrospectively in case of emergency inclusion.

Exclusion Criteria

* The absence of an arterial catheter for blood sampling.
* Medical history of home mechanical ventilation
* Severe ARDS (PaO2/FiO2 ≤ 100 mmHg)
* Head trauma or other conditions where intra-cranial pressure may be elevated and tight regulation of arterial CO2 level is paramount.
* Severe neurological patients (Glasgow coma score \<10, neurologic damage with limited prognosis, stroke hemiplegia).
* Known or suspected severe myopathy or neuropathy (including ICU neuromyopathy)
* Quadriplegia
* Severe heart failure
* Broncho alveolar fistula with more than 100ml leakage
* History of home mechanical ventilation
* Pregnancy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No