Intellivent Versus Conventional Ventilation

Respiratory Failure Clinical Trial

— Intellivent  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577667
• Other study ID #: Intellivent RCT1
• Status: Completed
• Phase: Phase 3
• First received: April 11, 2012
• Last updated: December 5, 2012
• Start date: February 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2012
• Source: Hamilton Medical AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency
• Self Efficacy

Intervention

Device:
• 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

Locations

Country	Name	City	State
Belgium	Polyvalent Intensive Care, St Luc Clinics	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Medical AG

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	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	Yes
Secondary	Efficacy	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	No
Secondary	Care workload	Care workload is assessed by the number of ventilator setting adjustments by nursing staff in each group.	48H	No