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

Not Applicable

• Conditions: Respiration, Artificial
• Interventions: Device: open loop weaning group (Beacon); Other: Routine care

• Registration Number: NCT02842944
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-25
• Study Start: 2017-12-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-21
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open loop weaning group (Beacon)	open loop weaning group (Beacon)	mechanical ventilation following advice from the Beacon Caresystem
Routine care	Routine care	* Connect and start Beacon with advice disabled * Standardized routine care

Primary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	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	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	14 days	the time after point of randomization, from initiation of support modes of ventilation and until successful extubation

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France