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

Hamilton Medical

Status: Terminated

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

Treatments: Device: Non-automated ventilation; Device: INTELLiVENT-ASV

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04400643

EASiVENT

Details and patient eligibility

About

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.

Full 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)

Enrollment: 62 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

INTELLiVENT-ASV

Experimental group

Description:

INTELLiVENT-ASV is a software accessory that automatically adjusts ventilation and oxygenation variables to keep the patient within clinician-set target ranges, from intubation until extubation.

Treatment:

Device: INTELLiVENT-ASV

Non-Automated ventilation

Active Comparator group

Description:

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

Treatment:

Device: Non-automated ventilation