Acute Respiratory FailureNCT04400643
EASiVENT Study Comparing INTELLiVENT-ASV vs Non Automated Ventilation in Adult ICU Patients
A study testing INTELLiVENT-ASV and Non-automated ventilation in people with Acute Respiratory Failure and Coma, run by Hamilton Medical AG at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Respiratory Failure, Coma, Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- INTELLiVENT-ASV and Non-automated ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Mar 2020to 18 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro Hospitalar Universitário de Lisboa Central
Lisbon, 1150-199
About this study
Official title: 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.
Read the 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
- Being tested
- INTELLiVENT-ASV, Non-automated ventilation
- Medical subject headings
- Coma, Respiratory Distress Syndrome, Pulmonary Disease, Chronic Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTELLiVENT-ASVDevice
INTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges.
Non-automated ventilationDevice
In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: INTELLiVENT-ASV |
| Non-Automated ventilation | Active comparator | In conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. Receives: Device: Non-automated ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 7 days after enrollment.
Secondary outcomes (8)
Fraction of Inspiration Oxygen (FiO2) (%)
FiO2 was measured breath-by-breath for all the study periods.
Measured: 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.
Measured: up to 28 days after enrollment
Positive End-Expiratory Pressure (PEEP) (cm H2O)
PEEP was measured breath-by-breath for all the study period.
Measured: up to 28 days after enrollment
Tidal Volume (ml)
Tidal volume was measured breath-by-breath for all the study period.
Measured: 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
Measured: up to 28 days after enrollment
Ventilation - Respiratory Rate
Respiratory rate was measured breath-by-breath for all the study period.
Measured: 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.
Measured: 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.
Measured: up to 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start20 Mar 2020
- Primary completion18 Jul 2022
- Study completion18 Jul 2022
Why it stopped: Sponsor decided to terminate the study, to terminate enrollment at this time is solely due to business reasons. No safety concerns related to the device have been identified which have in any way impacted the decision to stop the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Medical AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400643
- Sponsor's protocol ID
- EASiVENT
- Status last verified
- Oct 2024
- First submitted
- 14 May 2020
- Last updated
- 23 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Title: Prospective, Multicenter, Randomized, Controlled Study Comparing Efficacy and Safety of INTELLiVENT-ASV Versus Non-automated Ventilation in Adult ICU Subjects.
- ClinicalTrials.gov ID
- NCT04400643
- Acronym / sponsor ID
- EASiVENT
- Conditions
- Acute Respiratory Failure, Coma, Acute Respiratory Distress Syndrome (ARDS), Chronic Obstructive Pulmonary Disease (COPD), Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided to terminate the study, to terminate enrollment at this time is solely due to business reasons. No safety concerns related to the device have been identified which have in any way impacted the decision to stop the study.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hamilton Medical AGIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTELLiVENT-ASV | Experimental | Device: INTELLiVENT-ASVINTELLiVENT-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. |
| Non-Automated ventilation | Active comparator | Device: Non-automated ventilationIn conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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, )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTELLiVENT-ASVINTELLiVENT-ASV is software accessory that automatically adjust ventilation and oxygenation variables to keep the patient within clinician-set target ranges. | Device | INTELLiVENT-ASV |
| Non-automated ventilationIn conventional ventilation modes, clinicians adjust and modify the oxygenation and ventilation parameters manually. | Device | Non-Automated ventilation |
Primary outcome
Efficacy Measured as Percentage of Time Spent in Optimal Range
Time frame: 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
Time frame: 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.
8 secondary outcomes
Fraction of Inspiration Oxygen (FiO2) (%)
Time frame: up to 28 days after enrollment
Expiratory Time Constant (s)
Time frame: up to 28 days after enrollment
Positive End-Expiratory Pressure (PEEP) (cm H2O)
Time frame: up to 28 days after enrollment
Tidal Volume (ml)
Time frame: up to 28 days after enrollment
Tidal Volume mL/kg Ideal Body Weight (IBW)
Time frame: up to 28 days after enrollment
Ventilation - Respiratory Rate
Time frame: up to 28 days after enrollment
Numbers of Manual Settings Changes Per Day
Time frame: up to 28 days after enrollment
Automatic Settings Changes Per Day
Time frame: up to 28 days after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Acute Respiratory Failure
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
Recruiting
Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit
Chronic Respiratory Failure, Acute Respiratory Failure
Not yet recruitingObservational study
Impact of Inspiratory Effort and Patient-Ventilator Interaction During the Transition Phase
Mechanically Ventilated Patients, Acute Respiratory Failure (ARF)
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTELLiVENT-ASV and Non-automated ventilation in people with Acute Respiratory Failure and Coma, run by Hamilton Medical AG at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Measured as Percentage of Time Spent in Optimal Range (time frame: up to 7 days after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.