Weaning Algorithm for Mechanical VEntilation

NCT03697785 | Unknown DMC

• 2 other identifiers: REC Reference: 18/LO/0282239144
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 2

Brief Summary

To compare the duration of mechanical ventilation and the weaning period between two groups of patients managed with either Standard Care or with mechanical ventilation adjusted according to the Beacon Caresystem, in patients receiving mechanical ventilation for more than 24 hours

Conditions

Respiration, Artificial; Critical Care; Respiratory Insufficiency; Intensive Care (ICU) Myopathy; Mechanical Ventilation Complication

Keywords

weaning; cardiothoracic; mechanical ventilation; intensive care; critical care; beacon caresystem

Outcome Measures

Primary Outcomes (1)

• Duration of mechanical ventilation

  Defined as the time from the start of mechanical ventilation, defined as either the time of intubation in the ICU (or the time of admission to the ICU following previous intubation for surgery) and until successful extubation, with successful extubation defined as ≥48 hours of unassisted spontaneous breathing after extubation.

  Until the date of discharge from ICU, up to 12 months.

Secondary Outcomes (47)

• Duration of mechanical ventilation following randomisation

  Until the date of discharge from ICU, up to 12 months.

• Time from control mode to support mode

  Until the date of discharge from ICU, up to 12 months.

• Time from support mode to successful extubation

  Until the date of discharge from ICU, up to 12 months.

• Number of changes in ventilator settings per day

  Until the date of discharge from ICU, up to 12 months.

• Time to first spontaneous breathing test (SBT)

  Until the date of discharge from ICU, up to 12 months.

Study Arms (2)

Beacon Caresystem with weaning advice

EXPERIMENTAL

Beacon care system set up to give weaning advice and options to accept or reject advice.

Device: Beacon Care System

Beacon Caresystem for monitoring only

OTHER

Beacon care system attached but only for data collection purposes. No advice will be given.

Device: Beacon Care System

Interventions

Beacon Care System DEVICE

Beacon has been developed by Mermaid Care in Denmark. BEACON is a critical care ventilation assist system (http://beaconcaresystem.com/beacon-5/), which potentially enables better ventilation strategies and a more efficient patient care workflow. As an add-on to standard ventilation systems it provides ventilation recommendations 24/7 based on non-stop, personalised monitoring/diagnostics of patients. Based on unique mathematical algorithms and physiological models, it recommends changes in ventilation settings, supporting the critical decision-making processes.

Beacon Caresystem for monitoring only; Beacon Caresystem with weaning advice

Eligibility Criteria

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

You may qualify if:

• Patient remains on mechanical ventilation at 24 hours following intubation.
• Age \> 18 years
• Patient consent or, in the case that the patient is unable, advice from the next of kin or treating physician following understanding and acceptance of oral and written information describing the study.

You may not qualify if:

• The absence of an arterial catheter for blood sampling at study start.
• Mechanical ventilation initiated for more than 48 hours.
• Medical history of home mechanical ventilation which may lead to prolonged stay in the ICU, including long term oxygen therapy and non-invasive ventilation not associated with sleep apnoea.
• Patients mechanically ventilated in a ventilator mode, and by a ventilator not supported by the Beacon Caresystem on screening.
• Respiratory failure likely requiring extracorporeal support.
• Severe cardiogenic shock likely requiring extracorporeal support.
• Severe isolated right heart failure.
• Head trauma or other conditions where intra-cranial pressure may be elevated and tight regulation of arterial CO2 level is paramount.
• Primary (non-overdose related) neurological patients (Glasgow coma score \<10, neurologic damage with limited prognosis, stroke hemiplegia).
• End stage liver disease.
• Repeated ICU admission within same hospital admission and/or likely to have prolonged ICU stay with mechanical ventilation (\>21 days)
• Pregnancy.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Mermaid Care A/S: collaborator
• Aalborg University: collaborator
• Imperial College London: collaborator

Study Sites (2)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

RECRUITING

Harefield Hospital

Uxbridge, UB9 6JH, United Kingdom

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Respiratory Aspiration; Respiratory Insufficiency; Muscular Diseases

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Brijesh Patel, MBBS PhD

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brijesh V Patel, MBBS MRCP FRCA FFICM PhD

CONTACT

+44 (0)20 7352 8121; brijesh.patel@imperial.ac.uk

Cliff Morgan, MBBS FRCA

CONTACT

+44 (0)20 7352 8121; c.morgan@rbht.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 5, 2018
• Study Start: September 24, 2018
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

GB (2)