EASiVENT Study Comparing INTELLiVENT-ASV vs Non Automated Ventilation in Adult ICU Patients

Hamilton Medical AG62 enrolled

Overview

The purpose of the study is to assess the safety and efficacy of INTELLiVENT-ASV (Adaptive Support Ventilation) in adult ICU patients comparing to non automated ventilation.

EASiVENT is a prospective, multicenter, randomized (1:1), Controlled Study. This study is single-blind because only the subject will be unaware of the ventilation modality administered. The reference treatment used for comparison is a combination of controlled modes for passive subjects (volume control or pressure control) and assisted/spontaneous modes for active subjects (synchronized intermittent mechanical ventilation or pressure support)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Acute Respiratory Failure Coma Acute Respiratory Distress Syndrome (ARDS)Chronic Obstructive Pulmonary Disease (COPD)Obesity

Interventions

INTELLiVENT-ASVDEVICE

INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.

Non-automated ventilationDEVICE

In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Weight greater than 40 kg * Under invasive ventilation * Expected to be mechanically ventilated after enrollment for at least 24 hours * Agrees to not participate in other interventional research studies involving mechanical ventilation for the duration of study * Signature of the informed consent by the patient or his/her next-of-kin according to country or state regulation. Exclusion Criteria: * Fulfilling weaning criteria according to the weaning procedure of the ICU * Need for "rescue therapy" (e.g: ECMO) * Brain death status * Respiratory drive disorder (Cheyne-Stokes breathing) * Arterial hypoxia due to a non-pulmonary condition (right-to-left shunting due to congenital disease, hepato-pulmonary syndrome, ) * Broncho-pleural fistula * Chronic or acute dyshemoglobinemia: eg.: acute CO poisoning * Chronic respiratory failure requiring long term invasive ventilation; * Moribund patient * Patient under guardianship, deprived of liberties * Any other condition, that in the opinion of the IoR/designee, would preclude informed consent (by the spouse/next of kin), make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. * Low quality index on the SpO2 (Oxygen Saturation Measured by Pulse Oximetry) measurement * Patients already enrolled in the present study in a previous episode of acute respiratory failure * High PaCO2 - ETCO2 gap (\> 2.6 kPa or 19.5 mmHg) for \> 3 hours * Patient tracheostomized at the time of inclusion * Patient ventilated with helium

Locations (1)

Centro Hospitalar Universitário de Lisboa Central

Lisbon, Portugal

Outcomes

Primary Outcomes

Efficacy Measured as Percentage of Time Spent in Optimal Range

Objective of this study is to compare the efficacy of the investigational automated ventilation (INTELLiVENT-ASV) with a control ventilation group (conventional non-automated ventilation) in ICU subjects. The hypothesis is that INTELLiVENT-ASV is better than conventional non-automated ventilation in terms of efficacy. Efficacy endpoints are composite endpoints \& are based on six variables that will be continuously recorded during the study period: These 6 variables: tidal volume, respiratory rate, end tidal CO2, SpO2, maximum inspiratory pressure, and maximum inspiratory pressure minus positive end-expiratory pressure. Each breath was analyzed and the breath was considered as optimal when all six variables were within predefined optimal ranges

Time frame: up to 7 days after enrollment

Safety Measured as Percentage of Time Spent in Sub-optimal Range

Objective of this study is to compare the safety of the investigational automated ventilation (INTELLiVENT-ASV) with a control ventilation group (conventional non-automated ventilation) in ICU subjects. The hypothesis is that INTELLiVENT-ASV is better than conventional non-automated ventilation in terms of safety. Safety endpoints are composite endpoints \& are based on six variables that will be continuously recorded during the study period: sub-optimal range: tidal volume, respiratory rate, end tidal CO2, SpO2, maximum inspiratory pressure, and maximum inspiratory pressure minus positive end-expiratory pressure. Each breath was analyzed and the breath was considered as sub-optimal when at least one of the six variables was within predefined sub-optimal ranges.

Time frame: 7 days after enrollment.

Secondary Outcomes

Fraction of Inspiration Oxygen (FiO2) (%)

FiO2 was measured breath-by-breath for all the study periods.

Time frame: up to 28 days after enrollment

Expiratory Time Constant (s)

Expiratory time constant was calculated breath-by-breath as the ratio of volume divided by flow at 75% of the expired volume.

Data from ClinicalTrials.gov

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