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

NCT02842944 | Completed

• 1 other identifier: PI2016_843_0018
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiration, Artificial

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

open loop weaning group (Beacon)

EXPERIMENTAL

mechanical ventilation following advice from the Beacon Caresystem

Device: open loop weaning group (Beacon)

Routine care

ACTIVE COMPARATOR

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

Other: Routine care

Interventions

open loop weaning group (Beacon) DEVICE

mechanical ventilation following advice from the Beacon Caresystem

open loop weaning group (Beacon)

Routine care OTHER

Standardized routine care

Routine care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elie ZOGHEIB, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 25, 2016
• Study Start: December 12, 2017
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

FR (1)