Intellivent Versus Conventional Ventilation (Intellivent)

December 5, 2012 updated by: Hamilton Medical AG

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brussels, Belgium, 1200
        • Polyvalent Intensive Care, St Luc Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 48 Hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 48 Hours

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.

48 Hours
Care workload
Time Frame: 48H
Care workload is assessed by the number of ventilator setting adjustments by nursing staff in each group.
48H

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pierre-François Laterre, Pr, Reanimation, Cliniques Universitaires Saint Luc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 11, 2012

First Submitted That Met QC Criteria

April 12, 2012

First Posted (Estimate)

April 16, 2012

Study Record Updates

Last Update Posted (Estimate)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 5, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • Intellivent RCT1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Failure

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