Clinical trial NCT01577667: Intellivent Versus Conventional Ventilation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Failure
Self Efficacy
Keywords: automation
closed loop
oxygenation
ventilation
Lead sponsor: Hamilton Medical AG
Sponsor class: INDUSTRY
First posted: 2012-04-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: Safety
timeFrame: 48 Hours
Secondary outcomes:
measure: Efficacy
timeFrame: 48 Hours
measure: Care workload
timeFrame: 48H
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Polyvalent Intensive Care, St Luc Clinics
Study officials:
affiliation: Reanimation, Cliniques Universitaires Saint Luc
name: Pierre-François Laterre, Pr
role: PRINCIPAL_INVESTIGATOR
References: