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

Respiration, Artificial Clinical Trial

— BEACON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02842944
• Other study ID #: PI2016_843_0018
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2017
• Est. completion date: September 2019

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Elie ZOGHEIB, PhD
• Phone: +33 3 22 08 78 32
• Email: Zogheib.Elie[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiration, Artificial

Intervention

Device:
• open loop weaning group (Beacon)
mechanical ventilation following advice from the Beacon Caresystem

Other:
• Routine care
Standardized routine care

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 days
Primary	Time to successful extubation	time from randomization and until successful extubation.	Successful extubation is defined as = 7 days of unassisted spontaneous breathing after extubation
Primary	Time from support mode to successful extubation	the time after point of randomization, from initiation of support modes of ventilation and until successful extubation	14 days