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.

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Chronic Obstructive Pulmonary Disease (COPD); Coma; Acute Respiratory Failure; Acute Respiratory Distress Syndrome (ARDS)
• Intervention / Treatment: Device: INTELLiVENT-ASV; Device: 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)

• Study Type: Interventional
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Portugal
  • Lisbon, Portugal, 1150-199
    • Centro Hospitalar Universitário de Lisboa Central

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: INTELLiVENT-ASV; INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Active Comparator: Non-Automated ventilation; In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.	Device: Non-automated ventilation; In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	7 days after enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fraction of Inspiration Oxygen (FiO2) (%)	FiO2 was measured breath-by-breath for all the study periods.	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.	up to 28 days after enrollment
Positive End-Expiratory Pressure (PEEP) (cm H2O)	PEEP was measured breath-by-breath for all the study period.	up to 28 days after enrollment
Tidal Volume (ml)	Tidal volume was measured breath-by-breath for all the study period.	up to 28 days after enrollment
Tidal Volume mL/kg Ideal Body Weight (IBW)	Tidal volume mL/kg ideal body weight (IBW) will be assessed automatically breath-by-breath	up to 28 days after enrollment
Ventilation - Respiratory Rate	Respiratory rate was measured breath-by-breath for all the study period.	up to 28 days after enrollment
Numbers of Manual Settings Changes Per Day	The total number of automatic setting changes was recorded during the study period. Automatic settings included inspiratory pressure, pressure support, respiratory rate, PEEP, and inspired oxygen fraction.	up to 28 days after enrollment
Automatic Settings Changes Per Day	The total number of automatic setting changes was recorded during the study period. Automatic settings included inspiratory pressure, pressure support, respiratory rate, PEEP, and inspired oxygen fraction.	up to 28 days after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality at 28 Days (n (%))		up to 28 days after enrollment
Duration Invasive Mechanical Ventilation (Days)	Mechanical ventilation duration was recorded from the date of intubation to the date of last extubation or death if the patient died while still intubated.	up to 28 days from enrollment
Passive Ventilation Duration (h)	Passive ventilation is defined when the percentage of subject's triggered breath is lower than 25% of total respiratory rate.	up to 28 days from enrollment
Ventilator Free Days at Day 28 (d)		up to 28 days from enrollment
Percentage of Time in Allocated Mode (%)	The percentage of time in the allocated mode was calculated breath-by-breath according to the ventilation mode used.	up to 28 days after enrollment
Efficacy Measured as Percentage of Time Spent in Optimal Range	Percentage of time spent in optimal range was calculated breath-by-breath during all the study period. Breath were classified as optimal when all six variables were in predefined optimal range: tidal volume, respiratory rate, end tidal CO2, SpO2, maximum inspiratory pressure, and maximum inspiratory pressure minus positive end-expiratory pressure.	up to 28 days from enrollment
Safety Measured as Percentage of Time Spent in Sub-optimal Range	Percentage of time spent in sub-optimal range was calculated breath-by-breath during all the study period. Breath were classified as sub-optimal when at least one variable was in predefined sub-optimal range: tidal volume, respiratory rate, end tidal CO2, SpO2, maximum inspiratory pressure, and maximum inspiratory pressure minus positive end-expiratory pressure.	up to 28 days from enrollment

Collaborators and Investigators

• Sponsor: Hamilton Medical AG
• Collaborators: Hamilton Medical Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): July 18, 2022

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury
• Other Study ID Numbers: EASiVENT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO