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

NCT04400643 | Terminated Results DMC

• 1 other identifier: EASiVENT
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Fraction of Inspiration Oxygen (FiO2) (%)

  up to 28 days after enrollment

• Expiratory Time Constant (s)

  up to 28 days after enrollment

• Positive End-Expiratory Pressure (PEEP) (cm H2O)

  up to 28 days after enrollment

• Tidal Volume (ml)

  up to 28 days after enrollment

• Tidal Volume mL/kg Ideal Body Weight (IBW)

  up to 28 days after enrollment

Other Outcomes (7)

• Mortality at 28 Days (n (%))

  up to 28 days after enrollment

• Duration Invasive Mechanical Ventilation (Days)

  up to 28 days from enrollment

• Passive Ventilation Duration (h)

  up to 28 days from enrollment

Study Arms (2)

INTELLiVENT-ASV

EXPERIMENTAL

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

Non-Automated ventilation

ACTIVE COMPARATOR

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

Device: Non-automated ventilation

Interventions

INTELLiVENT-ASV DEVICE

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

INTELLiVENT-ASV

Non-automated ventilation DEVICE

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

Non-Automated ventilation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 ventilated with helium

Sponsors & Collaborators

• Hamilton Medical AG: lead

Study Sites (1)

Centro Hospitalar Universitário de Lisboa Central

Lisbon, 1150-199, Portugal

Location

MeSH Terms

Conditions

Coma; Respiratory Distress Syndrome; Pulmonary Disease, Chronic Obstructive; Obesity

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Limitations and Caveats

Premature termination resulted in a small sample size, preventing the execution of statistical analysis due to the limited number of participants in each group. The findings presented solely rely on the continuous recording of ventilator variables. Consequently, certain data captured in the electronic Case Report Form (eCRF) intended for secondary analysis, including plateau pressure, driving pressure, and blood gas results, were not taken into account.

Results Point of Contact

• Title: Jean Michel Arnal
• Organization: Hamilton Medical AG

jarnal@hamilton-medical.com

+33 1 84 04 97 58

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 22, 2020
• Study Start: March 20, 2020
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)