Polyvalent Intensive Care, St Luc Clinics
Brussels, 1200, Belgium
NCT Number: NCT01577667
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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Notify Me18 year–90 year
All sexes
Interventional
Phase 3
Brussels, 1200, Belgium
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:
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
Time frame: 48H
Care workload is assessed by the number of ventilator setting adjustments by nursing staff in each group.
Hamilton Medical AG
Industry
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
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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