Mechanical VentilationINTELLiPOWERNCT04827927
The Effect of Closed-Loop Versus Conventional Ventilation on Mechanical Power
A study testing Procedure: INTELLiVENT-ASV and Procedure: Conventional ventilation in people with Mechanical Ventilation and Mechanical Power, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in Netherlands.
Trial summary
Several studies suggest fully-automated ventilation to ventilate with a lower amount of MP in unselected ICU patients, patients after cardiac surgery, and patients with and without ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Mechanical Power
- What is being tested?
- Procedure: INTELLiVENT-ASV and Procedure: Conventional ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 3 sitesNetherlands
- Study dates
- 5 Jul 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to one of the participating ICUs;
- Receiving invasive ventilation through a standard endotracheal (i.e., oral) tube;
- Expected to be ventilated > 24 hours; and
- Ventilation is applied by a ventilator that can provide INTELLiVENT-ASV and conventional ventilation.
Who cannot join
- Age under 18 years;
- No written informed consent;
- Morbidly obese; and
- Any contra-indication for use of INTELLiVENT-ASV
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Academic Medical Center
Amsterdam, North Holland, 1105 AZ
Reinier de Graaf Gasthuis
Delft
Dijklander Ziekenhuis
Hoorn
About this study
Official title: The Effect of Closed-Loop Versus Conventional Ventilation on Mechanical Power - a Multicenter Crossover Randomized Clinical Trial
Several studies suggest fully-automated ventilation to ventilate with a lower amount of MP in unselected ICU patients, patients after cardiac surgery, and patients with and without ARDS. The current study will directly compare the amount of MP in invasively ventilated critically ill patients by calculating MP breath-by-breath, using the various equations proposed in the literature.
Read the detailed description
Rationale:
Mechanical ventilation can cause ventilator-induced lung injury (VILI). Lung protective ventilation, consisting of a low tidal volume (VT), a low plateau pressure (Pplateau) and a low driving pressure (ΔP) improves survival and shortens duration of ventilation in patients with acute respiratory distress syndrome (ARDS). Lung protective ventilation may also benefit critically ill patients with respiratory failure not caused by ARDS. 'Mechanical Power of ventilation' (MP), the amount of energy per time transferred from the ventilator to the respiratory system, is a summary variable that includes all the components that play a role in VILI. With fully-automated closed-loop ventilation, these components are no longer set by the operator, but under control of the algorithms in the ventilator.
Objective:
To compare MP under INTELLiVENT-adaptive support ventilation (ASV), a fully-automated closed-loop ventilation, with MP under conventional ventilation.
Hypothesis:
INTELLiVENT-ASV compared to conventional ventilation results in a lower MP.
Study design:
National, multicenter, crossover, randomized clinical trial.
Study population:
Invasively ventilated critically ill patients.
Methods:
The ventilator will be randomly switched between INTELLiVENT-ASV for 3 hours and conventional ventilation for 3 hours. The amount of MP is calculated using various equations proposed in the literature.
Study endpoints:
The primary endpoint is the amount of MP with each form of invasive ventilation.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Differences in burden and risks of the two ventilation strategies compared in the current study are not expected. Both modes of ventilation are interchangeably used as part of standard care in the participating centers. No other interventions are performed. Neither the collection of demographic and outcome data, nor the capturing of ventilation characteristics causes harm to patients.
- Conditions
- Mechanical Ventilation, Mechanical Power
- Being tested
- Procedure: INTELLiVENT-ASV, Procedure: Conventional ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: INTELLiVENT-ASVProcedure or surgery
With INTELLiVENT-ASV, the patient's conditions, 'ARDS', 'Chronic Hypercapnia' or 'Traumatic Brain Injury' can be chosen, if applicable. The controllers for minute volume, PEEP and FiO2 are all activated, and the target shifts for etCO2 and SpO2 are adjusted, if necessary.
Procedure: Conventional ventilationProcedure or surgery
With conventional ventilation, the same etCO2 and SpO2 levels are targeted as with INTELLiVENT-ASV, but here the caregiver is fully responsible for choosing the settings.
| Study group | Role | What they receive |
|---|---|---|
| INTELLiVENT-ASV | Experimental | Use of INTELLiVENT-ASV during 3 hours with 30 minutes wash-out time before. Receives: Procedure: Procedure: INTELLiVENT-ASV |
| Conventional Ventilation | Active comparator | Use of conventional ventilation during 3 hours with 30 minutes wash-out time before. Receives: Procedure: Procedure: Conventional ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of MP delivered with each form of invasive ventilation
The amount of MP delivered with INTELLiVENT-ASV and conventional ventilation
Measured: 3 hours per ventilation mode
Secondary outcomes (7)
Duration of ventilation
Duration of ventilation in survivors
Measured: first 28 days after start of ventilation
ICU-length and hospital of stay
Length of stay in the intensive care unit and in the hospital
Measured: first 28 days after start of ventilation
28 day-mortality
Any death during ICU-, hospital-stay and within 28 days
Measured: first 28 days after start of ventilation
Tidal volume
Tidal volume in ml/kg
Measured: 3 hours per ventilation mode
Respiratory rate
Respiratory rate per minute
Measured: 3 hours per ventilation mode
Pmax
Maximum airway pressure in cmH2O
Measured: 3 hours per ventilation mode
Driving pressure
Difference between end-inspiratory pressure and total Positieve End Expiratory Pressure in cmH2O
Measured: 3 hours per ventilation mode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start5 Jul 2021
- Primary completion1 Apr 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies 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
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- Reinier de Graaf Groep, Dijklander Ziekenhuis, University of Zurich
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Marcus J Schultz, MD, PhD, Principal investigator, Department of Intensive Care, Amsterdam University Medical Centre - location AMCFrederique Paulus, PhD, Study director, Department of Intensive Care, Amsterdam University Medical Centre - location AMCLaura A Buiteman-Kruizinga, RN, BSc, Study director, Department of Intensive Care, Amsterdam University Medical Centre - location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827927
- Sponsor's protocol ID
- INTELLiPOWER
- Acronym
- INTELLiPOWER
- Status last verified
- Aug 2023
- First submitted
- 29 Mar 2021
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Serafini SC, Geerts JWHJ, Neto AS, List SS, von During S, Tschernko E, Buhler P, Mazzinari G, Paulus F, Schultz MJ, Buiteman-Kruizinga LA; INTELLiPOWER collaborative investigators. Discrepancies between estimated and geometrically derived mechanical power in invasively ventilated patients - insights from a randomized clinical trial. Intensive Care Med Exp. 2026 Aug 18;14(1):107. doi: 10.1186/s40635-026-00956-8.
PubMed 42611407Buiteman-Kruizinga LA, Serpa Neto A, Botta M, List SS, de Boer BH, van Velzen P, Buhler PK, Wendel Garcia PD, Schultz MJ, van der Heiden PLJ, Paulus F; INTELLiPOWER-investigators. Effect of automated versus conventional ventilation on mechanical power of ventilation-A randomized crossover clinical trial. PLoS One. 2024 Jul 30;19(7):e0307155. doi: 10.1371/journal.pone.0307155. eCollection 2024.
PubMed 39078857
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Closed-Loop Versus Conventional Ventilation on Mechanical Power - a Multicenter Crossover Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04827927
- Acronym / sponsor ID
- INTELLiPOWER / INTELLiPOWER
- Conditions
- Mechanical Ventilation, Mechanical Power
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Reinier de Graaf Groep, Dijklander Ziekenhuis, University of Zurich
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several studies suggest fully-automated ventilation to ventilate with a lower amount of MP in unselected ICU patients, patients after cardiac surgery, and patients with and without ARDS. The current study will directly compare the amount of MP in invasively ventilated critically ill patients by calculating MP breath-by-breath, using the various equations proposed in the literature.
Detailed description
Rationale:
Mechanical ventilation can cause ventilator-induced lung injury (VILI). Lung protective ventilation, consisting of a low tidal volume (VT), a low plateau pressure (Pplateau) and a low driving pressure (ΔP) improves survival and shortens duration of ventilation in patients with acute respiratory distress syndrome (ARDS). Lung protective ventilation may also benefit critically ill patients with respiratory failure not caused by ARDS. 'Mechanical Power of ventilation' (MP), the amount of energy per time transferred from the ventilator to the respiratory system, is a summary variable that includes all the components that play a role in VILI. With fully-automated closed-loop ventilation, these components are no longer set by the operator, but under control of the algorithms in the ventilator.
Objective:
To compare MP under INTELLiVENT-adaptive support ventilation (ASV), a fully-automated closed-loop ventilation, with MP under conventional ventilation.
Hypothesis:
INTELLiVENT-ASV compared to conventional ventilation results in a lower MP.
Study design:
National, multicenter, crossover, randomized clinical trial.
Study population:
Invasively ventilated critically ill patients.
Methods:
The ventilator will be randomly switched between INTELLiVENT-ASV for 3 hours and conventional ventilation for 3 hours. The amount of MP is calculated using various equations proposed in the literature.
Study endpoints:
The primary endpoint is the amount of MP with each form of invasive ventilation.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Differences in burden and risks of the two ventilation strategies compared in the current study are not expected. Both modes of ventilation are interchangeably used as part of standard care in the participating centers. No other interventions are performed. Neither the collection of demographic and outcome data, nor the capturing of ventilation characteristics causes harm to patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTELLiVENT-ASV | Experimental | Procedure: Procedure: INTELLiVENT-ASVUse of INTELLiVENT-ASV during 3 hours with 30 minutes wash-out time before. |
| Conventional Ventilation | Active comparator | Procedure: Procedure: Conventional ventilationUse of conventional ventilation during 3 hours with 30 minutes wash-out time before. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted to one of the participating ICUs;
- Receiving invasive ventilation through a standard endotracheal (i.e., oral) tube;
- Expected to be ventilated > 24 hours; and
- Ventilation is applied by a ventilator that can provide INTELLiVENT-ASV and conventional ventilation.
Key exclusion criteria (4 listed)
- Age under 18 years;
- No written informed consent;
- Morbidly obese; and
- Any contra-indication for use of INTELLiVENT-ASV
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 |
|---|---|---|
| Procedure: INTELLiVENT-ASVWith INTELLiVENT-ASV, the patient's conditions, 'ARDS', 'Chronic Hypercapnia' or 'Traumatic Brain Injury' can be chosen, if applicable. The controllers for minute volume, PEEP and FiO2 are all activated, and the target shifts for etCO2 and SpO2 are adjusted, if necessary. | Procedure or surgery | INTELLiVENT-ASV |
| Procedure: Conventional ventilationWith conventional ventilation, the same etCO2 and SpO2 levels are targeted as with INTELLiVENT-ASV, but here the caregiver is fully responsible for choosing the settings. | Procedure or surgery | Conventional Ventilation |
Primary outcome
The amount of MP delivered with each form of invasive ventilation
Time frame: 3 hours per ventilation mode
The amount of MP delivered with INTELLiVENT-ASV and conventional ventilation
7 secondary outcomes
Duration of ventilation
Time frame: first 28 days after start of ventilation
ICU-length and hospital of stay
Time frame: first 28 days after start of ventilation
28 day-mortality
Time frame: first 28 days after start of ventilation
Tidal volume
Time frame: 3 hours per ventilation mode
Respiratory rate
Time frame: 3 hours per ventilation mode
Pmax
Time frame: 3 hours per ventilation mode
Driving pressure
Time frame: 3 hours per ventilation mode
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Derived from this study: PubMed 42611407Serafini SC, Geerts JWHJ, Neto AS, List SS, von During S, Tschernko E, Buhler P, Mazzinari G, Paulus F, Schultz MJ, Buiteman-Kruizinga LA; INTELLiPOWER collaborative investigators. Discrepancies between estimated and geometrically derived mechanical power in invasively ventilated patients - insights from a randomized clinical trial. Intensive Care Med Exp. 2026 Aug 18;14(1):107. doi: 10.1186/s40635-026-00956-8.
- Derived from this study: PubMed 39078857Buiteman-Kruizinga LA, Serpa Neto A, Botta M, List SS, de Boer BH, van Velzen P, Buhler PK, Wendel Garcia PD, Schultz MJ, van der Heiden PLJ, Paulus F; INTELLiPOWER-investigators. Effect of automated versus conventional ventilation on mechanical power of ventilation-A randomized crossover clinical trial. PLoS One. 2024 Jul 30;19(7):e0307155. doi: 10.1371/journal.pone.0307155. eCollection 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Mechanical Ventilation
Not yet recruitingObservational study
Early Switch in Moderate ARDS
Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
Not yet recruitingObservational study
Predicting the Need for Invasive Mechanical Ventilation Using Different Risk Scores
High Flow Oxygen Therapy, Non Invasive Ventilation (NIV)
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Not yet recruitingObservational study
Detecting Early Weaning-induced Pulmonary Oedema Using Lung Impedance Negative Trend During Spontaneous Breathing Trials
Weaning-induced Pulmonary Edema, Mechanical Ventilation Weaning
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.
Marcus J Schultz, MD, PhD principal investigator
Department of Intensive Care, Amsterdam University Medical Centre - location AMC
Frederique Paulus, PhD study director
Department of Intensive Care, Amsterdam University Medical Centre - location AMC
Laura A Buiteman-Kruizinga, RN, BSc study director
Department of Intensive Care, Amsterdam University Medical Centre - location AMC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: INTELLiVENT-ASV and Procedure: Conventional ventilation in people with Mechanical Ventilation and Mechanical Power, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in Netherlands.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The amount of MP delivered with each form of invasive ventilation (time frame: 3 hours per ventilation mode). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04827927, which also lists 2 linked publications.
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 24 Aug 2023.