Ventilator LungPOSITiVE IINCT06178510
I-ASV in Cardiac Surgery
A study testing INTELLiVENT-ASV. in people with Ventilator Lung, run by Medical University of Vienna at 1 site in Austria.
Trial summary
'POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II) is an investigator-initiated, international, multicenter, parallel, randomized clinical trial in patients after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Ventilator Lung
- What is being tested?
- INTELLiVENT-ASV.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteAustria
- Study dates
- 31 May 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. aged > 18 years of age;
- 2. scheduled for elective cardiac surgery; and
- 3. expected to receive postoperative ventilation in the ICU for > 2 hours.
Who cannot join
- any emergency or semi-elective surgery (precluding informed written consent);
- any surgery other than CABG, valve replacement or repair, or a combination (i.e., patients planned for surgery for congenital heart disease, or scheduled for heart transplantation are excluded);
- enrolled in another interventional trail;
- no written informed consent obtained;
- history of recent pneumectomy or lobectomy;
- history of COPD with oxygen at home;
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- body mass index > 35;
- preoperative forced expiratory volume in the first second (FeV1)/forced vital capacity (VC) < 50% (if available);
- preoperative arterial oxygen partial pressure (PaO2) < 60 mm Hg (at room air);
- preoperative arterial carbon dioxide partial pressure (PaCO2) > 50 mm Hg;
- preoperative left ventricular ejection fraction < 30% (if available);
- preoperative systolic pulmonary artery pressure > 60 mm Hg (if available);
- preoperative left ventricular mechanical support, e.g., Impella®; or
- preoperative use of veno-venous or veno-arterial extracorporeal support
- At the end of surgery, patients are additionally excluded if a patient:
- cannot be weaned from the extracorporeal support; or
- unexpectedly needs implementation of an assist device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, State of Vienna, A-1090
Martin H Bernardi, MD, PhD, 004314040041090, martin.bernardi@meduniwien.ac.at
Martin H Bernardi, MD, PhD
About this study
Official title: POStoperative INTELLiVENT-adaptive Support VEntilation in Cardiac Surgery Patients II (POSITiVE II) - a Randomized Clinical Trial
'POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II) is an investigator-initiated, international, multicenter, parallel, randomized clinical trial in patients after cardiac surgery.
Read the detailed description
To compare INTELLiVENT-ASV with conventional ventilation with respect to (i.) quality of ventilation; and (ii.) ICU nursing staff workload in an international cohort of participants receiving postoperative ventilation after cardiac surgery. This study will also determine the effects of INTELLiVENT-ASV on clinical outcomes, including (iii.) duration of postoperative ventilation and (iv.) length of stay in ICU.
- Conditions
- Ventilator Lung
- Being tested
- INTELLiVENT-ASV.
- Keywords
- Adaptative Support Ventilation, INTELLiVENT, Cardiac Surgery, Workload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTELLiVENT-ASV.Device
INTELLiVENT-ASV® is a closed-loop ventilation mode that automatically adjusts respiratory rate and tidal volume according to the oxygen and ventilatory patient needs
| Study group | Role | What they receive |
|---|---|---|
| INTELLiVENT-ASV | Other | The ventilator set parameters such as tidal volume, respiratory rate, and positive end-expiratory pressure to ensure adequate ventilation and oxygenation. The investigators monitor it and define clinical target. Receives: Device: INTELLiVENT-ASV. |
| conventional ventilation | No intervention | The investigators set and monitor parameters such as tidal volume, respiratory rate, and positive end-expiratory pressure to ensure adequate ventilation and oxygenation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of ventilation
The primary outcome is quality of ventilation, which is the proportion of time spent in three predefined and previously used zones of ventilation in the first 2 hours of postoperative ventilation.
- An optimal zone = Tidal volume (TV) = 4-8 ml/kg of the predicted body weight (PBW) with an EtCO2 = 30-45mmHg, a plateau pressure = <31cmH2O and SpO2 = 93-98%.
- An acceptable zone = TV = 8-12 ml/kg of PBW with an EtCO2 = 25-30 or 45-50mmHg, a plateau pressure = 31-35 cmH2O and SpO2 = 85-93% or >98%.
- An unacceptable zone = TV >12 ml/kg of PBW or an EtCO2 = <25 or >50mmHg, plateau pressure >35 cmH2O or SpO2 = <85%.
Measured: During the first 2 hours, since admission on the ICU with the start of the intervention ventilation mode.
Secondary outcomes (7)
ICU nursing staff workload
ICU nursing staff workload, which is captured by the ventilator software collecting data on alarms (number of alarms, types of alarm, duration of alarm, responses to alarm, alarm settings and adjustments, breath-by-breath alarm data, and any manual intervention at the ventilator) during postoperative care in the ICU
Measured: 24 hours
Duration of postoperative ventilation
The time from admission on the ICU until extubation.
Measured: 8 hours or until extubation
Patient-ventilator asynchrony
patient-ventilator asynchrony requiring deepening of sedation and/or administration of muscle relaxants
Measured: Up to 6 hours of mechanical ventilation time
Proportion of breath spent in zones of ventilation
Proportion of breaths spent in predefined and previously used zones of ventilation in the first 6 hours of postoperative ventilation.
- An optimal zone = Tidal volume (TV) = 4-8 ml/kg of the predicted body weight (PBW) with an EtCO2 = 30-45mmHg, a plateau pressure = <31cmH2O and SpO2 = 93-98%.
- An acceptable zone = TV = 8-12 ml/kg of PBW with an EtCO2 = 25-30 or 45-50mmHg, a plateau pressure = 31-35 cmH2O and SpO2 = 85-93% or >98%.
- An unacceptable zone = TV >12 ml/kg of PBW or an EtCO2 = <25 or >50mmHg, plateau pressure >35 cmH2O or SpO2 = <85%.
Measured: Up to 6 hours of mechanical ventilation time
ICU length of stay
Length of stay in the ICU
Measured: From date of ICU admission until the date of ICU discharge, assessed up to 30 days
Hospital length of stay
Length of stay in hospital
Measured: From date of hospital admission until the date of hospital discharge, assessed up to 30 days
Mortality
Mortality in ICU or hospital
Measured: 28-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start31 May 2024
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator LungStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Dubrava, Università degli Studi dell'Insubria, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Zurich
- Responsible party
- Principal investigator, Prof. Dr. Edda Tschernko, Medical University of Vienna
- Investigators
- Edda Tschernko, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178510
- Sponsor's protocol ID
- POSITiVE II v1.1
- Acronym
- POSITiVE II
- Status last verified
- Oct 2024
- First submitted
- 4 Dec 2023
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results of the study will find their way into (inter-) national scientific journals and guidelines. We will submit a summary of results to scientific journals in the field of anesthesiology.
Publications
Bernardi MH, Bettex D, Buiteman-Kruizinga LA, de Bie A, Hoffmann M, de Kleijn J, Serafini SC, Molenaar MA, Paulus F, Persec J, Neto AS, Schuepbach R, Severgnini P, Sribar A, Schultz MJ, Tschernko E; POSITiVE II-investigators. POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients (POSITiVE) II-study protocol of a randomized clinical trial. Trials. 2024 Jul 3;25(1):449. doi: 10.1186/s13063-024-08296-2.
PubMed 38961468
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POStoperative INTELLiVENT-adaptive Support VEntilation in Cardiac Surgery Patients II (POSITiVE II) - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06178510
- Acronym / sponsor ID
- POSITiVE II / POSITiVE II v1.1
- Conditions
- Ventilator Lung
- Keywords
- Adaptative Support Ventilation, INTELLiVENT, Cardiac Surgery, Workload
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- University Hospital Dubrava, Università degli Studi dell'Insubria, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Zurich
- Study start
- 31 May 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Dec 2023 (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.
'POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II) is an investigator-initiated, international, multicenter, parallel, randomized clinical trial in patients after cardiac surgery.
Detailed description
To compare INTELLiVENT-ASV with conventional ventilation with respect to (i.) quality of ventilation; and (ii.) ICU nursing staff workload in an international cohort of participants receiving postoperative ventilation after cardiac surgery. This study will also determine the effects of INTELLiVENT-ASV on clinical outcomes, including (iii.) duration of postoperative ventilation and (iv.) length of stay in ICU.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTELLiVENT-ASV | Other | Device: INTELLiVENT-ASV.The ventilator set parameters such as tidal volume, respiratory rate, and positive end-expiratory pressure to ensure adequate ventilation and oxygenation. The investigators monitor it and define clinical target. |
| conventional ventilation | No intervention | –The investigators set and monitor parameters such as tidal volume, respiratory rate, and positive end-expiratory pressure to ensure adequate ventilation and oxygenation. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. aged > 18 years of age;
- 2. scheduled for elective cardiac surgery; and
- 3. expected to receive postoperative ventilation in the ICU for > 2 hours.
Key exclusion criteria (17 listed)
- any emergency or semi-elective surgery (precluding informed written consent);
- any surgery other than CABG, valve replacement or repair, or a combination (i.e., patients planned for surgery for congenital heart disease, or scheduled for heart transplantation are excluded);
- enrolled in another interventional trail;
- no written informed consent obtained;
- history of recent pneumectomy or lobectomy;
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-ASV.INTELLiVENT-ASV® is a closed-loop ventilation mode that automatically adjusts respiratory rate and tidal volume according to the oxygen and ventilatory patient needs | Device | INTELLiVENT-ASV |
Primary outcome
Quality of ventilation
Time frame: During the first 2 hours, since admission on the ICU with the start of the intervention ventilation mode.
The primary outcome is quality of ventilation, which is the proportion of time spent in three predefined and previously used zones of ventilation in the first 2 hours of postoperative ventilation. * An optimal zone = Tidal volume (TV) = 4-8 ml/kg of the predicted body weight (PBW) with an EtCO2 = 30-45mmHg, a plateau pressure = <31cmH2O and SpO2 = 93-98%. * An acceptable zone = TV = 8-12 ml/kg of PBW with an EtCO2 = 25-30 or 45-50mmHg, a plateau pressure = 31-35 cmH2O and SpO2 = 85-93% or >98%. * An unacceptable zone = TV >12 ml/kg of PBW or an EtCO2 = <25 or >50mmHg, plateau pressure >35 cmH2O or SpO2 = <85%.
7 secondary outcomes
ICU nursing staff workload
Time frame: 24 hours
Duration of postoperative ventilation
Time frame: 8 hours or until extubation
Patient-ventilator asynchrony
Time frame: Up to 6 hours of mechanical ventilation time
Proportion of breath spent in zones of ventilation
Time frame: Up to 6 hours of mechanical ventilation time
ICU length of stay
Time frame: From date of ICU admission until the date of ICU discharge, assessed up to 30 days
Hospital length of stay
Time frame: From date of hospital admission until the date of hospital discharge, assessed up to 30 days
Mortality
Time frame: 28-day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Derived from this study: PubMed 38961468Bernardi MH, Bettex D, Buiteman-Kruizinga LA, de Bie A, Hoffmann M, de Kleijn J, Serafini SC, Molenaar MA, Paulus F, Persec J, Neto AS, Schuepbach R, Severgnini P, Sribar A, Schultz MJ, Tschernko E; POSITiVE II-investigators. POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients (POSITiVE) II-study protocol of a randomized clinical trial. Trials. 2024 Jul 3;25(1):449. doi: 10.1186/s13063-024-08296-2.
- Individual participant dataSharing planned: Undecided. The results of the study will find their way into (inter-) national scientific journals and guidelines. We will submit a summary of results to scientific journals in the field of anesthesiology.
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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.
Edda Tschernko, MD principal investigator
Medical University of Vienna
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. in people with Ventilator Lung, run by Medical University of Vienna 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 3 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 4 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edda Tschernko, MD (00 43 1 40400 41090, edda.tschernko@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of ventilation (time frame: During the first 2 hours, since admission on the ICU with the start of the intervention 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 NCT06178510, which also lists 1 linked publication.
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 4 Nov 2024.