NCT04400643

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

Study Title: Prospective, Multicenter, Randomized, Controlled Study Comparing Efficacy and Safety of INTELLiVENT-ASV Versus Non-automated Ventilation in Adult ICU Subjects.

• Status: Terminated
• Phase: —
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Hamilton Medical AG · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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)

Conditions

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

Interventions

Type	Name	Description
DEVICE	INTELLiVENT-ASV	INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
DEVICE	Non-automated ventilation	In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

Timeline

• Start date: 2020-03-20
• Primary completion: 2022-07-18
• Completion: 2022-07-18
• First posted: 2020-05-22
• Last updated: 2024-10-23
• Results posted: 2024-10-23

Locations

1 site across 1 country: Portugal