Clinical trial NCT04400643: EASiVENT Study Comparing INTELLiVENT-ASV vs Non Automated Ventilation in Adult ICU Patients
Official title: Study Title: Prospective, Multicenter, Randomized, Controlled Study Comparing Efficacy and Safety of INTELLiVENT-ASV Versus Non-automated Ventilation in Adult ICU Subjects.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Conditions: Acute Respiratory Failure
Coma
Acute Respiratory Distress Syndrome (ARDS)
Chronic Obstructive Pulmonary Disease (COPD)
Obesity
Lead sponsor: Hamilton Medical AG
Sponsor class: INDUSTRY
First posted: 2020-05-22
Enrollment: 62
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy Measured as Percentage of Time Spent in Optimal Range
timeFrame: up to 7 days after enrollment
measure: Safety Measured as Percentage of Time Spent in Sub-optimal Range
timeFrame: 7 days after enrollment.
Secondary outcomes:
measure: Fraction of Inspiration Oxygen (FiO2) (%)
timeFrame: up to 28 days after enrollment
measure: Expiratory Time Constant (s)
timeFrame: up to 28 days after enrollment
measure: Positive End-Expiratory Pressure (PEEP) (cm H2O)
timeFrame: up to 28 days after enrollment
measure: Tidal Volume (ml)
timeFrame: up to 28 days after enrollment
measure: Tidal Volume mL/kg Ideal Body Weight (IBW)
timeFrame: up to 28 days after enrollment
measure: Ventilation - Respiratory Rate
timeFrame: up to 28 days after enrollment
measure: Numbers of Manual Settings Changes Per Day
timeFrame: up to 28 days after enrollment
measure: Automatic Settings Changes Per Day
timeFrame: up to 28 days after enrollment
Other outcomes:
measure: Mortality at 28 Days (n (%))
timeFrame: up to 28 days after enrollment
measure: Duration Invasive Mechanical Ventilation (Days)
timeFrame: up to 28 days from enrollment
measure: Passive Ventilation Duration (h)
timeFrame: up to 28 days from enrollment
measure: Ventilator Free Days at Day 28 (d)
timeFrame: up to 28 days from enrollment
measure: Percentage of Time in Allocated Mode (%)
timeFrame: up to 28 days after enrollment
measure: Efficacy Measured as Percentage of Time Spent in Optimal Range
timeFrame: up to 28 days from enrollment
measure: Safety Measured as Percentage of Time Spent in Sub-optimal Range
timeFrame: up to 28 days from enrollment
Locations:
city: Lisbon
country: Portugal
facility: Centro Hospitalar Universitário de Lisboa Central
Study officials:
References: