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Intellivent Versus Conventional Ventilation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hamilton Medical AG
ClinicalTrials.gov Identifier:
NCT01577667
First received: April 11, 2012
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Respiratory Failure
Self Efficacy
 Device: Intellivent; automatic mode implemented on a S1 ventilator
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Comparative Monocenter RCT Comparing Safety and Efficacy of an Automated Closed-loop Oxygenation and Ventilation(IntelliVent® System - HAMILTON MEDICAL AG) With Non-automated Conventional Ventilation and Oxygenation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hamilton Medical AG:

Primary Outcome Measures:
  • Safety [ Time Frame: 48 Hours ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 48 Hours ] [ Designated as safety issue: No ]

    Efficacy, in terms of ventilation, is assessed by the time spent within a range EtCO2 and Pplat-proxi and VT and RR values considered as optimal, as defined a priori and consensually by a panel of experts.

    Efficacy, in terms of oxygenation, is assessed by the time spent within a range SpO2 values considered as optimal, as defined a priori and consensually by a panel of experts.


  • Care workload [ Time Frame: 48H ] [ Designated as safety issue: No ]
    Care workload is assessed by the number of ventilator setting adjustments by nursing staff in each group.


Enrollment: 80
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional ventilation
Usual ventilation is administered according to the protocols implemented in the unit
Experimental: Intellivent

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
Intellivent allows an automatic adjustment of the following parameters: FiO2, PEEP and %VM according to adjusted parameters: Size, SpO2 and EtCO2
Other Name: Closed-loop ventilation

Detailed Description:

Rational: Partial automation of mechanical ventilation in resuscitation has been available for several years. It can deliver a continuous ventilation adapted in real time to the patient's clinical condition,and decrease care workload and ventilation weaning duration. New modalities are being developed to completely automate ventilation and oxygenation parameters (IntelliVent®) and preliminary studies show that over short periods (2 to 4 h) such a system can ventilate patients more optimally and more safely, with a better ventilation efficiency (comparable effect on gas exchanges for a less "aggressive" ventilation). This pilot study compares over a longer period (48 hours), the safety and efficacy of IntelliVent®, versus a usual ventilation modality.

Type of study: Monocenter, comparative, prospective, randomized, parallel study.

Objective: To assess IntelliVent® safety, efficacy, and care workload.

Assessment criteria:

  • 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.
  • Efficacy, in terms of ventilation, is assessed by the time spent within a range EtCO2 and Pplat and VT and RR values considered as optimal, as defined a priori and consensually by a panel of experts.

Efficacy, in terms of oxygenation, is assessed by the time spent within a range SpO2 values considered as optimal, as defined a priori and consensually by a panel of experts.

- Care workload is assessed by the number of ventilator setting adjustments by nursing staff in each group.

Number of subjects: 80 patients receiving invasive mechanical ventilation for acute respiratory failure.

Methods: The selected patients presenting with inclusion criteria are ventilated either with IntelliVent® or with the unit's usual ventilation following a random selection.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Inclusion in another study protocol under consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577667

Locations
Belgium
Polyvalent Intensive Care, St Luc Clinics
Brussels, Belgium, 1200
Sponsors and Collaborators
Hamilton Medical AG
Investigators
Principal Investigator: Pierre-François Laterre, Pr Reanimation, Cliniques Universitaires Saint Luc
  More Information

No publications provided

Responsible Party: Hamilton Medical AG
ClinicalTrials.gov Identifier: NCT01577667     History of Changes
Other Study ID Numbers: Intellivent RCT1
Study First Received: April 11, 2012
Last Updated: December 5, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by Hamilton Medical AG:
automation
closed loop
oxygenation
ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013