Respiration, ArtificialBEACONNCT02842944
Weaning From Mechanical Ventilation Comparison of Open-loop Decision Support System and Routine Care
A study testing open loop weaning group (Beacon) and Routine care in people with Respiration, Artificial, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration, Artificial
- What is being tested?
- open loop weaning group (Beacon) and Routine care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2017to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- Quadriplegia
- Severe heart failure
- Broncho alveolar fistula with more than 100ml leakage
- History of home mechanical ventilation
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Respiration, Artificial
- Being tested
- open loop weaning group (Beacon), Routine care
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open loop weaning group (Beacon)Device
mechanical ventilation following advice from the Beacon Caresystem
Routine careOther
Standardized routine care
| Study group | Role | What they receive |
|---|---|---|
| open loop weaning group (Beacon) | Experimental | mechanical ventilation following advice from the Beacon Caresystem Receives: Device: open loop weaning group (Beacon) |
| Routine care | Active comparator | * Connect and start Beacon with advice disabled
* Standardized routine care Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation
time from initial intubation and until successful extubation, with successful extubation defined as ≥ 7 days of unassisted spontaneous breathing after extubation.
Measured: 14 days
Time to successful extubation
time from randomization and until successful extubation.
Measured: Successful extubation is defined as ≥ 7 days of unassisted spontaneous breathing after extubation
Time from support mode to successful extubation
the time after point of randomization, from initiation of support modes of ventilation and until successful extubation
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study start12 Dec 2017
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elie ZOGHEIB, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842944
- Sponsor's protocol ID
- PI2016_843_0018
- Acronym
- BEACON
- Status last verified
- Jun 2026
- First submitted
- 21 Jul 2016
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning From Mechanical Ventilation Comparison of Open-loop Decision Support System and Routine Care
- ClinicalTrials.gov ID
- NCT02842944
- Acronym / sponsor ID
- BEACON / PI2016_843_0018
- Conditions
- Respiration, Artificial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 25 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open loop weaning group (Beacon) | Experimental | Device: open loop weaning group (Beacon)mechanical ventilation following advice from the Beacon Caresystem |
| Routine care | Active comparator | Other: Routine care* Connect and start Beacon with advice disabled * Standardized routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| open loop weaning group (Beacon)mechanical ventilation following advice from the Beacon Caresystem | Device | open loop weaning group (Beacon) |
| Routine careStandardized routine care | Other | Routine care |
Primary outcome
Duration of mechanical ventilation
Time frame: 14 days
time from initial intubation and until successful extubation, with successful extubation defined as ≥ 7 days of unassisted spontaneous breathing after extubation.
Time to successful extubation
Time frame: Successful extubation is defined as ≥ 7 days of unassisted spontaneous breathing after extubation
time from randomization and until successful extubation.
Time from support mode to successful extubation
Time frame: 14 days
the time after point of randomization, from initiation of support modes of ventilation and until successful extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elie ZOGHEIB, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open loop weaning group (Beacon) and Routine care in people with Respiration, Artificial, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of mechanical ventilation (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.