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

NCT ID: NCT04400643

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-20
• Study Completion Date: 2022-07-18

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)

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

INTELLiVENT-ASV

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.

Group Type: EXPERIMENTAL

INTELLiVENT-ASV

Intervention Type: DEVICE

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

Non-Automated ventilation

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

Group Type: ACTIVE_COMPARATOR

Non-automated ventilation

Intervention Type: DEVICE

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

Interventions

INTELLiVENT-ASV

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

Intervention Type: DEVICE

Non-automated ventilation

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Medical AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro Hospitalar Universitário de Lisboa Central

Lisbon, , Portugal

Countries

Portugal

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

EASiVENT

Identifier Type: -

Identifier Source: org_study_id