Mechanical VentilationPOWER-FLOWNCT06222463
Power Dissipation in Flow-controlled Ventilation
A study testing Evone in people with Mechanical Ventilation and Abdominal Surgery, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The goal of this randomized clinical cross-over trial is to compare power dissipation (Pd) during flow-controlled ventilation with either standard of low tidal volume ventilation or compliance guided individualization of ventilator settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Abdominal Surgery
- What is being tested?
- Evone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 31 Jan 2024to 30 May 2025
- 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
- Male and female subjects ≥ 18 years
- Body weight ≥ 40 kg
- Elective open abdominal surgery under general anaesthesia - American Society of Anesthesiologists Classification I-III
- Written informed consent
Who cannot join
- Emergency surgery
- American Society of Anesthesiologists Classification IV-V
- Female subjects known to be pregnant
- Known participation in another interventional clinical trial
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Innsbruck
Innsbruck, Tyrol, 6020
Patrick Spraider, PhD, +43 512 504 80329, patrick.spraider@i-med.ac.at
About this study
Official title: Power Dissipation in Low Tidal Volume Versus Individualized Flow-controlled Ventilation - a Randomized, Clinical Cross-over Trial
The goal of this randomized clinical cross-over trial is to compare power dissipation (Pd) during flow-controlled ventilation with either standard of low tidal volume ventilation or compliance guided individualization of ventilator settings. This study is performed in patients scheduled for open abdominal surgery and the primary and secondary outcome parameters are:
- power dissipation [J/min] during ventilation calculated by integrating the hysteresis of the tracheal pressure-volume loop
- applied mechanical power during ventilation calculated by published formulas [1]
- oxygenation of the blood assessed by PaO2/FiO2 ratio
- decarboxylation assessed by required respiratory minute volume to maintain normocapnia
- comparison of respiratory variables in low tidal volume versus individualized ventilation Participants will randomly receive either low tidal volume (LTV) or individualized flow-controlled ventilation [2]. In the LTV group, the positive end-expiratory pressure will be set to 5 cmH2O and the peak pressure set to achieve a tidal volume of 7 ml/kg predicted body weight. In the individualized group positive end-expiratory and peak pressure will be titrated to achieve the highest compliance [2]. In both groups the flow will be set to achieve normocapnia (PaCO2 35-45 mmHg). After obtaining three consecutive measurements the ventilation strategy will be switched to the alternative regime in a cross-over design and again, three measurements recorded.
The investigators hypothesize, that individualized ventilator settings are able to improve ventilation efficiency in terms of a lower required minute volume to maintain normocapnia and thus is able to reduce power dissipation during ventilation. Secondary endpoint will be a comparison of Pd to calculated mechanical power, as a currently accepted surrogate parameter for ventilation invasiveness [2] and also outcome predictor. Additionally, gas exchange parameters such as oxygenation and decarboxylation will be compared between low tidal volume and individualized ventilation.
Read the detailed description
After anesthesia induction and securing the airway with a tracheal tube, tha patients will be ventilated with flow-controlled ventilation (FCV) using standard of low tidal volume ventilation with a positive end-expiratory pressure (PEEP) of 5 cmH2O and the peak pressure set to achieve a tidal volume of 7 ml/kg predicted body weight. I:E ration will be set to 1:1, the gas flow adjusted to achieve normocapnia and the fraction of inspired oxygen adjusted to achieve normoxia. After opening the abdominal cavity baseline parameters will be recorded and subsequently the study participant randomized to one of the following treatment group:
- low tidal volume ventilation (LTV): PEEP will be set to 5 cmH2O, peak pressure adjusted to achieve a tidal volume of 7 ml/kg predicted body weight and the flow set to achieve normocapnia (PaCO2 of 35-45 mmHg)
- individualized FCV: PEEP and peak pressure will be titrated based on dynamic compliance. First PEEP well be increased or decreased until the highest tidal volume at the same driving pressure can be achieved. Then the driving pressure or peak pressure will be increased, until there is no further over-proportional increase in tidal volume (previous tidal volume + measured compliance). Finally the gas flow will be set to achieve normocapnia (PaCO2 of 35-45 mmHg) Three measurements will be obtained with 15 minutes in between and subsequently the ventilation setting switched to the alternative group, followed by additional three consecutive measurements. After obtaining all study related measurements the observation period ends and the patient will be further treated with the ventilation strategy that results in the lowest energy dissipation.
- Conditions
- Mechanical Ventilation, Abdominal Surgery
- Being tested
- Evone
- Keywords
- Flow-controlled Ventilation, Power Dissipation, Mechanical Power
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvoneDevice
Evone (Ventinova Medical B.V., Eindhoven, The Netherlands) is a ventilator, which is able to perform flow-controlled ventilation (FCV). Moreover it provides direct tracheal pressure measurements and combined with the constant gas flow of FCV a precise determination of dynamic compliance is feasible. Thus not only PEEP but also peak pressure can be titrated based on dynamic compliance. Additionally intratracheal pressure-volume loops can be measured and thus power dissipation calculated, which represents the primary outcome parameter of this trial.
| Study group | Role | What they receive |
|---|---|---|
| low tidal volume ventilation | Active comparator | Flow-controlled ventilation will be established with a PEEP of 5 cmH2O, peak pressure set to achieve a tidal volume of 7 ml/kg predicted body weight and the flow set to achieve normocapnia at an I:E ration of 1:1. Three consecutive measurements of power dissipation with 15 minutes in between will be obtained. Additionally secondary outcome parameters such as respiratory parameters and results of arterial blood gas analysis will be recorded at each measurement timepoint. Receives: Device: Evone |
| individualized FCV | Experimental | Flow-controlled ventilation will be individualized with compliance guided PEEP and peak pressure titration. The flow will be set to achieve normocapnia at an I:E ration of 1:1. Three consecutive measurements of power dissipation with 15 minutes in between will be obtained. Additionally secondary outcome parameters such as respiratory parameters and results of arterial blood gas analysis will be recorded at each measurement timepoint. Receives: Device: Evone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power dissipation (Pd)
The hysteresis of the tracheal pressure-volume relationship represents the power, that is dissipated during one ventilation cycle. Together with the respiratory rate, overall power dissipation can be calculated in J/min.
Measured: Pd will be calculated and recorded three times in each treatment arm with 15 minutes in between.
Secondary outcomes (3)
Mechanical power (MP)
Applied mechanical power during inspiration will be calculated based on a published formula by Gattinoni et al.
Measured: MP will be calculated and recorded three times in each treatment arm with 15 minutes in between.
PaO2/FiO2 ratio
Oxygenation will be assessed with the help of an arterial blood gas analysis
Measured: PaO2/FiO2 ratio will be measured and recorded three times in each treatment arm with 15 minutes in between.
Minute volume (MV)
Required respiratory minute volume to maintain normocapnia will be recorded.
Measured: MV will be recorded three times in each treatment arm with 15 minutes in between
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start31 Jan 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 May 2025 (estimated)
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
- Model description
- non-blinded, randomized, cross-over, controlled trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Spraider, PhD, Principal investigator, Medical University of Innsbruck, Department of Anesthesia and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222463
- Sponsor's protocol ID
- 1091/2023
- Acronym
- POWER-FLOW
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD can be requested from the principal investigator.
Publications
Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
PubMed 27620287Spraider P, Abram J, Martini J, Putzer G, Glodny B, Hell T, Barnes T, Enk D. Flow-controlled versus pressure-controlled ventilation in cardiac surgery with cardiopulmonary bypass - A single-center, prospective, randomized, controlled trial. J Clin Anesth. 2023 Dec;91:111279. doi: 10.1016/j.jclinane.2023.111279. Epub 2023 Oct 3.
PubMed 37797394
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Power Dissipation in Low Tidal Volume Versus Individualized Flow-controlled Ventilation - a Randomized, Clinical Cross-over Trial
- ClinicalTrials.gov ID
- NCT06222463
- Acronym / sponsor ID
- POWER-FLOW / 1091/2023
- Conditions
- Mechanical Ventilation, Abdominal Surgery
- Keywords
- Flow-controlled Ventilation, Power Dissipation, Mechanical Power
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 24 Jan 2024 (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.
The goal of this randomized clinical cross-over trial is to compare power dissipation (Pd) during flow-controlled ventilation with either standard of low tidal volume ventilation or compliance guided individualization of ventilator settings. This study is performed in patients scheduled for open abdominal surgery and the primary and secondary outcome parameters are:
- power dissipation [J/min] during ventilation calculated by integrating the hysteresis of the tracheal pressure-volume loop
- applied mechanical power during ventilation calculated by published formulas [1]
- oxygenation of the blood assessed by PaO2/FiO2 ratio
- decarboxylation assessed by required respiratory minute volume to maintain normocapnia
- comparison of respiratory variables in low tidal volume versus individualized ventilation Participants will randomly receive either low tidal volume (LTV) or individualized flow-controlled ventilation [2]. In the LTV group, the positive end-expiratory pressure will be set to 5 cmH2O and the peak pressure set to achieve a tidal volume of 7 ml/kg predicted body weight. In the individualized group positive end-expiratory and peak pressure will be titrated to achieve the highest compliance [2]. In both groups the flow will be set to achieve normocapnia (PaCO2 35-45 mmHg). After obtaining three consecutive measurements the ventilation strategy will be switched to the alternative regime in a cross-over design and again, three measurements recorded.
The investigators hypothesize, that individualized ventilator settings are able to improve ventilation efficiency in terms of a lower required minute volume to maintain normocapnia and thus is able to reduce power dissipation during ventilation. Secondary endpoint will be a comparison of Pd to calculated mechanical power, as a currently accepted surrogate parameter for ventilation invasiveness [2] and also outcome predictor. Additionally, gas exchange parameters such as oxygenation and decarboxylation will be compared between low tidal volume and individualized ventilation.
Detailed description
After anesthesia induction and securing the airway with a tracheal tube, tha patients will be ventilated with flow-controlled ventilation (FCV) using standard of low tidal volume ventilation with a positive end-expiratory pressure (PEEP) of 5 cmH2O and the peak pressure set to achieve a tidal volume of 7 ml/kg predicted body weight. I:E ration will be set to 1:1, the gas flow adjusted to achieve normocapnia and the fraction of inspired oxygen adjusted to achieve normoxia. After opening the abdominal cavity baseline parameters will be recorded and subsequently the study participant randomized to one of the following treatment group:
- low tidal volume ventilation (LTV): PEEP will be set to 5 cmH2O, peak pressure adjusted to achieve a tidal volume of 7 ml/kg predicted body weight and the flow set to achieve normocapnia (PaCO2 of 35-45 mmHg)
- individualized FCV: PEEP and peak pressure will be titrated based on dynamic compliance. First PEEP well be increased or decreased until the highest tidal volume at the same driving pressure can be achieved. Then the driving pressure or peak pressure will be increased, until there is no further over-proportional increase in tidal volume (previous tidal volume + measured compliance). Finally the gas flow will be set to achieve normocapnia (PaCO2 of 35-45 mmHg) Three measurements will be obtained with 15 minutes in between and subsequently the ventilation setting switched to the alternative group, followed by additional three consecutive measurements. After obtaining all study related measurements the observation period ends and the patient will be further treated with the ventilation strategy that results in the lowest energy dissipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-blinded, randomized, cross-over, controlled trial
| Arm | Type | Receives |
|---|---|---|
| low tidal volume ventilation | Active comparator | Device: EvoneFlow-controlled ventilation will be established with a PEEP of 5 cmH2O, peak pressure set to achieve a tidal volume of 7 ml/kg predicted body weight and the flow set to achieve normocapnia at an I:E ration of 1:1. Three consecutive measurements of power dissipation with 15 minutes in between will be obtained. Additionally secondary outcome parameters such as respiratory parameters and results of arterial blood gas analysis will be recorded at each measurement timepoint. |
| individualized FCV | Experimental | Device: EvoneFlow-controlled ventilation will be individualized with compliance guided PEEP and peak pressure titration. The flow will be set to achieve normocapnia at an I:E ration of 1:1. Three consecutive measurements of power dissipation with 15 minutes in between will be obtained. Additionally secondary outcome parameters such as respiratory parameters and results of arterial blood gas analysis will be recorded at each measurement timepoint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects ≥ 18 years
- Body weight ≥ 40 kg
- Elective open abdominal surgery under general anaesthesia - American Society of Anesthesiologists Classification I-III
- Written informed consent
Key exclusion criteria (4 listed)
- Emergency surgery
- American Society of Anesthesiologists Classification IV-V
- Female subjects known to be pregnant
- Known participation in another interventional clinical trial
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 |
|---|---|---|
| EvoneEvone (Ventinova Medical B.V., Eindhoven, The Netherlands) is a ventilator, which is able to perform flow-controlled ventilation (FCV). Moreover it provides direct tracheal pressure measurements and combined with the constant gas flow of FCV a precise determination of dynamic compliance is feasible. Thus not only PEEP but also peak pressure can be titrated based on dynamic compliance. Additionally intratracheal pressure-volume loops can be measured and thus power dissipation calculated, which represents the primary outcome parameter of this trial. | Device | individualized FCV, low tidal volume ventilation |
Primary outcome
Power dissipation (Pd)
Time frame: Pd will be calculated and recorded three times in each treatment arm with 15 minutes in between.
The hysteresis of the tracheal pressure-volume relationship represents the power, that is dissipated during one ventilation cycle. Together with the respiratory rate, overall power dissipation can be calculated in J/min.
3 secondary outcomes
Mechanical power (MP)
Time frame: MP will be calculated and recorded three times in each treatment arm with 15 minutes in between.
PaO2/FiO2 ratio
Time frame: PaO2/FiO2 ratio will be measured and recorded three times in each treatment arm with 15 minutes in between.
Minute volume (MV)
Time frame: MV will be recorded three times in each treatment arm with 15 minutes in between
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 27620287Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
- Background: PubMed 37797394Spraider P, Abram J, Martini J, Putzer G, Glodny B, Hell T, Barnes T, Enk D. Flow-controlled versus pressure-controlled ventilation in cardiac surgery with cardiopulmonary bypass - A single-center, prospective, randomized, controlled trial. J Clin Anesth. 2023 Dec;91:111279. doi: 10.1016/j.jclinane.2023.111279. Epub 2023 Oct 3.
- Individual participant dataSharing planned: No. The IPD can be requested from the principal investigator.
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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.
Patrick Spraider, PhD principal investigator
Medical University of Innsbruck, Department of Anesthesia and Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evone in people with Mechanical Ventilation and Abdominal Surgery, run by Medical University Innsbruck at 1 site in Austria.
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: status not confirmed, as of the sponsor's last update on 12 Mar 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Spraider, PhD (+43 512 504 80329, patrick.spraider@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power dissipation (Pd) (time frame: Pd will be calculated and recorded three times in each treatment arm with 15 minutes in between.). 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 NCT06222463, 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 12 Mar 2024.