Intellivent Versus Conventional Ventilation

NCT ID: NCT01577667

Last Updated: 2012-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-06-30

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.

Conditions

Respiratory Failure; Self Efficacy

Keywords

automation; closed loop; oxygenation; ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Conventional ventilation

Usual ventilation is administered according to the protocols implemented in the unit

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Intellivent; automatic mode implemented on a S1 ventilator

Intervention Type: DEVICE

Intellivent allows an automatic adjustment of the following parameters: FiO2, PEEP and %VM according to adjusted parameters: Size, SpO2 and EtCO2

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Closed-loop ventilation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Medical AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre-François Laterre, Pr

Role: PRINCIPAL_INVESTIGATOR

Reanimation, Cliniques Universitaires Saint Luc

Locations

Polyvalent Intensive Care, St Luc Clinics

Brussels, , Belgium

Countries

Belgium

Other Identifiers

Intellivent RCT1

Identifier Type: -

Identifier Source: org_study_id