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OpenTrials
Completed

NCT Number: NCT01577667

Intellivent Versus Conventional Ventilation

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Polyvalent Intensive Care, St Luc Clinics

Brussels, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Closed-loop ventilation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Care workload

    Time frame: 48H

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

Sponsors and collaborators

Lead sponsor

Hamilton Medical AG

Industry

Registry information

Official study 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

Acronym: Intellivent

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 16, 2012
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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