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

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 Overview

• Status: Unknown
• Conditions: Respiration, Artificial
• Intervention / Treatment: Device: open loop weaning group (Beacon); Other: Routine care

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elie ZOGHEIB, PhD; Phone Number: +33 3 22 08 78 32; Email: Zogheib.Elie@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens
    • Contact: Elie ZOGHEIB, PhD; Phone Number: +33 3 22 08 78 32; Email: Zogheib.Elie@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: open loop weaning group (Beacon); mechanical ventilation following advice from the Beacon Caresystem	Device: open loop weaning group (Beacon); mechanical ventilation following advice from the Beacon Caresystem
Active Comparator: Routine care; Connect and start Beacon with advice disabled; Standardized routine care	Other: Routine care; Standardized routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time to successful extubation	time from randomization and until successful extubation.	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	14 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Elie ZOGHEIB, PhD, CHU Amiens

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2017
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: July 21, 2016
• First Submitted That Met QC Criteria: July 21, 2016
• First Posted (Estimate): July 25, 2016

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PI2016_843_0018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No