Acute Respiratory Failure, Coma, Acute Respiratory Distress Syndrome (ARDS), Chronic Obstructive Pulmonary Disease (COPD), Obesity
Conditions
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)
Interventions
DEVICEINTELLiVENT-ASV
INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
DEVICENon-automated ventilation
In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.
Sponsors
Hamilton Medical AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Measured as Percentage of Time Spent in Optimal Range | up to 7 days after enrollment | 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 |
| Safety Measured as Percentage of Time Spent in Sub-optimal Range | 7 days after enrollment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expiratory Time Constant (s) | up to 28 days after enrollment | Expiratory time constant was calculated breath-by-breath as the ratio of volume divided by flow at 75% of the expired volume. |
| Fraction of Inspiration Oxygen (FiO2) (%) | up to 28 days after enrollment | FiO2 was measured breath-by-breath for all the study periods. |
| Positive End-Expiratory Pressure (PEEP) (cm H2O) | up to 28 days after enrollment | PEEP was measured breath-by-breath for all the study period. |
| Tidal Volume (ml) | up to 28 days after enrollment | Tidal volume was measured breath-by-breath for all the study period. |
| Tidal Volume mL/kg Ideal Body Weight (IBW) | up to 28 days after enrollment | Tidal volume mL/kg ideal body weight (IBW) will be assessed automatically breath-by-breath |
| Ventilation - Respiratory Rate | up to 28 days after enrollment | Respiratory rate was measured breath-by-breath for all the study period. |
| Numbers of Manual Settings Changes Per Day | up to 28 days after enrollment | 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. |
| Automatic Settings Changes Per Day | up to 28 days after enrollment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ventilator Free Days at Day 28 (d) | up to 28 days from enrollment | — |
| Percentage of Time in Allocated Mode (%) | up to 28 days after enrollment | The percentage of time in the allocated mode was calculated breath-by-breath according to the ventilation mode used. |
| Efficacy Measured as Percentage of Time Spent in Optimal Range | up to 28 days from enrollment | 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. |
| Safety Measured as Percentage of Time Spent in Sub-optimal Range | up to 28 days from enrollment | 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. |
| Duration Invasive Mechanical Ventilation (Days) | up to 28 days from enrollment | 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. |
| Mortality at 28 Days (n (%)) | up to 28 days after enrollment | — |
| Passive Ventilation Duration (h) | up to 28 days from enrollment | Passive ventilation is defined when the percentage of subject's triggered breath is lower than 25% of total respiratory rate. |
Countries
Portugal
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
INTELLiVENT-ASV: INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges. | 31 |
| Non-Automated Ventilation In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.
Non-automated ventilation: In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. | 31 |
| Total | 62 |
Baseline characteristics
| Characteristic | INTELLiVENT-ASV | Non-Automated Ventilation | Total |
|---|---|---|---|
| Age, Customized | 64 years | 67 years | 65 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 27 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 31 | 11 / 31 |
| other Total, other adverse events | 2 / 31 | 4 / 31 |
| serious Total, serious adverse events | 6 / 31 | 5 / 31 |
Outcome results
Primary
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
Time frame: up to 7 days after enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INTELLiVENT-ASV | Efficacy Measured as Percentage of Time Spent in Optimal Range | 28 percentage of time in optimal ranges |
| Non-Automated Ventilation | Efficacy Measured as Percentage of Time Spent in Optimal Range | 29 percentage of time in optimal ranges |
Primary
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.
Time frame: 7 days after enrollment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INTELLiVENT-ASV | Safety Measured as Percentage of Time Spent in Sub-optimal Range | 16 percentage of time in sub-optimal range |
| Non-Automated Ventilation | Safety Measured as Percentage of Time Spent in Sub-optimal Range | 13 percentage of time in sub-optimal range |
Secondary
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.
Time frame: up to 28 days after enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INTELLiVENT-ASV | Automatic Settings Changes Per Day | 1040 automatic setting changes per day |
| Non-Automated Ventilation | Automatic Settings Changes Per Day | 0 automatic setting changes per day |
Secondary
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.
Time frame: up to 28 days after enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INTELLiVENT-ASV | Expiratory Time Constant (s) | 0.59 second (s) |
| Non-Automated Ventilation | Expiratory Time Constant (s) | 0.54 second (s) |
Secondary
Fraction of Inspiration Oxygen (FiO2) (%)
FiO2 was measured breath-by-breath for all the study periods.
Time frame: up to 28 days after enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INTELLiVENT-ASV | Fraction of Inspiration Oxygen (FiO2) (%) | 31 percentage of inspired oxygen |
| Non-Automated Ventilation | Fraction of Inspiration Oxygen (FiO2) (%) | 36 percentage of inspired oxygen |
Secondary
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.
Time frame: up to 28 days after enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INTELLiVENT-ASV | Numbers of Manual Settings Changes Per Day | 12 manual setting changes per day |
| Non-Automated Ventilation | Numbers of Manual Settings Changes Per Day | 28 manual setting changes per day |
Secondary
Positive End-Expiratory Pressure (PEEP) (cm H2O)
PEEP was measured breath-by-breath for all the study period.
Time frame: up to 28 days after enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INTELLiVENT-ASV | Positive End-Expiratory Pressure (PEEP) (cm H2O) | 7.7 Cm H2O |
| Non-Automated Ventilation | Positive End-Expiratory Pressure (PEEP) (cm H2O) | 8.0 Cm H2O |
Secondary
Tidal Volume (ml)
Tidal volume was measured breath-by-breath for all the study period.
Time frame: up to 28 days after enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INTELLiVENT-ASV | Tidal Volume (ml) | 420 milliliter (ml) |
| Non-Automated Ventilation | Tidal Volume (ml) | 422 milliliter (ml) |
Secondary
Tidal Volume mL/kg Ideal Body Weight (IBW)
Tidal volume mL/kg ideal body weight (IBW) will be assessed automatically breath-by-breath
Time frame: up to 28 days after enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INTELLiVENT-ASV | Tidal Volume mL/kg Ideal Body Weight (IBW) | 6.8 ml/kg of ideal body weight (IBW) |
| Non-Automated Ventilation | Tidal Volume mL/kg Ideal Body Weight (IBW) | 6.6 ml/kg of ideal body weight (IBW) |
Secondary
Ventilation - Respiratory Rate
Respiratory rate was measured breath-by-breath for all the study period.
Time frame: up to 28 days after enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INTELLiVENT-ASV | Ventilation - Respiratory Rate | 20 breath/min |
| Non-Automated Ventilation | Ventilation - Respiratory Rate | 22 breath/min |
Other Pre-specified
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.
Time frame: up to 28 days from enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INTELLiVENT-ASV | Duration Invasive Mechanical Ventilation (Days) | 4.7 days |
| Non-Automated Ventilation | Duration Invasive Mechanical Ventilation (Days) | 5.3 days |
Other Pre-specified
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.
Time frame: up to 28 days from enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INTELLiVENT-ASV | Efficacy Measured as Percentage of Time Spent in Optimal Range | 22 percentage of time in optimal ranges |
| Non-Automated Ventilation | Efficacy Measured as Percentage of Time Spent in Optimal Range | 27 percentage of time in optimal ranges |
Other Pre-specified
Mortality at 28 Days (n (%))
Time frame: up to 28 days after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| INTELLiVENT-ASV | Mortality at 28 Days (n (%)) | 7 Participants |
| Non-Automated Ventilation | Mortality at 28 Days (n (%)) | 11 Participants |
Other Pre-specified
Passive Ventilation Duration (h)
Passive ventilation is defined when the percentage of subject's triggered breath is lower than 25% of total respiratory rate.
Time frame: up to 28 days from enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INTELLiVENT-ASV | Passive Ventilation Duration (h) | 52 hours (h) |
| Non-Automated Ventilation | Passive Ventilation Duration (h) | 42 hours (h) |
Other Pre-specified
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.
Time frame: up to 28 days after enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INTELLiVENT-ASV | Percentage of Time in Allocated Mode (%) | 100 percentage |
| Non-Automated Ventilation | Percentage of Time in Allocated Mode (%) | 100 percentage |
Other Pre-specified
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.
Time frame: up to 28 days from enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INTELLiVENT-ASV | Safety Measured as Percentage of Time Spent in Sub-optimal Range | 30 percentage of time in sub-optimal ranges |
| Non-Automated Ventilation | Safety Measured as Percentage of Time Spent in Sub-optimal Range | 21 percentage of time in sub-optimal ranges |
Other Pre-specified
Ventilator Free Days at Day 28 (d)
Time frame: up to 28 days from enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| INTELLiVENT-ASV | Ventilator Free Days at Day 28 (d) | 20 days |
| Non-Automated Ventilation | Ventilator Free Days at Day 28 (d) | 18 days |