Intellivent Versus Conventional Ventilation

NCT01577667 | Completed Phase 3 DMC

• 1 other identifier: Intellivent RCT1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Partial automation of mechanical ventilation in resuscitation has been available for several years. New modalities are being developed to completely automate ventilation and oxygenation parameters (IntelliVent®. This pilot study compares over a 48h period the safety and efficacy of IntelliVent®, versus a conventional ventilation modality.

Conditions

Respiratory Failure; Self Efficacy

Keywords

automation; closed loop; oxygenation; ventilation

Outcome Measures

Primary Outcomes (1)

• Safety

  Safety is assessed by measuring the number of times it is necessary to manually intervene on the ventilator settings because for one the following parameters: A range SpO2, EtCO2, plateau pressure (Pplat), tidal volume (VT), respiratory rate (RR) values considered as non-optimal, as defined a priori and consensually by a panel of experts.

  48 Hours

Secondary Outcomes (2)

• Efficacy

  48 Hours

• Care workload

  48H

Study Arms (2)

Conventional ventilation

NO INTERVENTION

Usual ventilation is administered according to the protocols implemented in the unit

Intellivent

EXPERIMENTAL

Intellivent is a ventilatory mode included in ventilator S1, Hamilton Medical. Intervention: the patient is ventilated with the same ventilator than in the conventionnal group; but the "ASV-Intellivent" ventilation has to be activated via a dedicated key on the ventilator screen. IntelliVent® activation requires selecting the kind of patient: ARDS, COPD and whether hemodynamic instability exists. The initial settings are IntelliVent® by default settings (% MV: 110%, PEEP: 5 cm H2O, FiO2: 60% - 100% in case of ARDS). Therefore modification of these various parameters is automatic. FiO2 and PEP are modified according to SpO2; %MV according to EtCO2.

Device: Intellivent; automatic mode implemented on a S1 ventilator

Interventions

Intellivent; automatic mode implemented on a S1 ventilator DEVICE

Intellivent allows an automatic adjustment of the following parameters: FiO2, PEEP and %VM according to adjusted parameters: Size, SpO2 and EtCO2

Also known as: Closed-loop ventilation

Intellivent

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Patient under invasive ventilation for more than 6 hours and for a planned duration of at least 48 hours
• Body Mass Index (current weight (kg)/height (m)²) \< 40
• Signature of an informed consent by the family

You may not qualify if:

• Need for ventricular assistance with intra-aortic balloon counterpulsation.
• Presence of a bronchopleural fistula
• Pregnant women: A pregnancy blood test will be performed in women of reproductive age. The results will be communicated to the patient by a physician of her choice.
• Adults under guardianship
• People deprived of freedom

Sponsors & Collaborators

• Hamilton Medical AG: lead

Study Sites (1)

Polyvalent Intensive Care, St Luc Clinics

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Aspiration

Condition Hierarchy (Ancestors)

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

Study Officials

• Pierre-François Laterre, Pr

  Reanimation, Cliniques Universitaires Saint Luc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 16, 2012
• Study Start: February 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

BE (1)