Positive-Pressure Respiration, IntrinsicNCT04534933
Flow Controlled Ventilation in Thoracic Surgery
A study testing Evone and Primus in people with Positive-Pressure Respiration, Intrinsic, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
This trial investigates effects of individualized (by compliance guided pressure settings) flow-controlled ventilation compared to best clinical practice pressure-controlled ventilation in thoracic surgery requiring one lung ventilation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Positive-Pressure Respiration, Intrinsic
- What is being tested?
- Evone and Primus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteAustria
- Study dates
- 29 Oct 2020to 16 Feb 2022
- 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 to 99 years
- 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 thoracic surgery requiring OLV
- ASA I-III
- Written informed consent
Who cannot join
- Emergency surgery
- Female subjects known to be pregnant
- Known participation in another interventional clinical trial
- high pulmonary risk (ppo FEV1<20ml/kg in male or ppo FEV1<18ml/kg in female)
- Empyema evacuation or signs of pulmonary infection
- High grade CMP (EF<30%)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flow Controlled Ventilation Versus Pressure Controlled Ventilation in Thoracic Surgery With One Lung Ventilation - a Prospective, Randomized Clinical Study
This trial investigates effects of individualized (by compliance guided pressure settings) flow-controlled ventilation compared to best clinical practice pressure-controlled ventilation in thoracic surgery requiring one lung ventilation.
Read the detailed description
Flow-controlled ventilation (FCV) is a novel ventilation method with promising first results in porcine studies as well as clinical cross-over trials. A more efficient and maybe lung protective ventilation strategy would be crucial in the challenging situation of one lung ventilation during thoracic surgery, when the whole gas exchange has to be provided by just one half of the lungs.
Thus, individualized FCV, based on compliance guided pressure settings, will be compared to standard of pressure-controlled ventilation in thoracic surgery requiring one lung ventilation in a randomized controlled trial. Based on previous preclinical trials an improvement of oxygenation by 15% will be expected and in order to transfer the preclinical results to humans oxygenation assessed by paO2 / FiO2 ratio after 30 minutes of one lung ventilation is the main primary outcome parameter of this study. Furthermore, improved recruitment of lung tissue due to controlled expiratory flow in FCV will be anticipated without the need of recruitment maneuvers, which may cause deleterious effects on lung tissue. Accordingly any recruitment maneuvers will be omitted in the FCV group.
The investigators hypothesize that improved gas exchange in terms of improved oxygenation and reduced respiratory minute volume required for CO2-removal will be achieved with FCV compared to PCV. Secondary outcome parameters such as the incidence of postoperative pulmonary complications will be additionally assessed in order to plan future studies with clinically relevant outcome.
- Conditions
- Positive-Pressure Respiration, Intrinsic
- Being tested
- Evone, Primus
- Keywords
- flow controlled ventilation, pressure controlled ventilation, thoracic surgery, one lung ventilation
- Medical subject headings
- Positive-Pressure Respiration, Intrinsic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvoneDevice
Airway ventilation device
PrimusDevice
Airway ventilation device
| Study group | Role | What they receive |
|---|---|---|
| FCV | Experimental | Artificial ventilation will be performed with individualized flow-controlled ventilation (Evone, Ventinova Medical B.V., Eindhoven, the Netherlands) during thoracic surgery. Individualization will be established by compliance guided end-expiratory and peak pressure setting during two lung ventilation as well as one lung ventilation, flow setting will be adjusted to secure normocapnia during two lung ventilation and the targeted paCO2 during one lung ventilation is 40-60 mmHg, provided that pH >7.2. The I:E ratio will be set to 1:1. The FiO2 will be set to achieve normoxia during two lung ventilation, increased to 100% before lung isolation and after 15 minutes of one-lung ventilation again decreased to secure normoxia or mild hyperoxia (target paO2 of 75-120 mmHg). No recruitment maneuver will be performed for re-inflation of the separated lung and after regain of spontaneous breathing tracheal extubation performed in the operating room. Receives: Device: Evone |
| PCV | Active comparator | Artificial ventilation will be performed with pressure-controlled ventilation (Primus, Dräger, Lübeck, Germany) during thoracic surgery. Peak pressure will be set to achieve a tidal volume of 6-8 ml/kg predicted body weight (PBW) at a compliance titrated positive end-expiratory pressure during two lung ventilation and the tidal volume will be reduced to 4-6 ml/kg PBW during one lung ventilation. Respiratory rate will be set to maintain normocapnia during two lung ventilation and a targeted paCO2 level during one lung ventilation of 40-60 mmHg, provided that pH > 7.2. The I:E ratio will be set to 1:1.5 except extension of expiration is necessary in order to avoid air trapping. The FiO2 will be set to achieve normoxia during two lung ventilation, increased to 100% before lung isolation until 15 minutes of one lung ventilation and decreased thereafter to achieve a targeted paO2 level of 75-120 mmHg. For re-inflation a manual recruitment maneuver will be performed under surgical guidance. Receives: Device: Primus |
What is being measured
The primary outcome is the main question the study is designed to answer.
paO2 / FiO2 ratio (Horowitz Index)
Comparison of oxygenation assessed by arterial partial pressure of oxygen (paO2) / fraction of inspired oxygen (FiO2)
Measured: after 30 minutes of one lung ventilation
Secondary outcomes (18)
decarboxylation (paCO2)
Required respiratory minute volume to achieve a taregeted paCO2 of 35-45 mmHg during two lung ventilation and 40-60 mmHg during one lung ventilation
Measured: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
venous admixture (Qs / Qt)
Comparison of calculated venous admixure from arterial and central venous blood gas analysis
Measured: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
respiratory minute volume
Comparison of respiratory minute volume
Measured: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
respiratory rate
Comparison of respiratory rate
Measured: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
tidal volume
Comparison of applied tidal volume
Measured: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
positive end-expiratory pressure
Comparison of set positive end-expiratory pressure
Measured: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
peak pressure
Comparison of set peak pressure
Measured: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
driving pressure
Comparison of resulting driving pressure
Measured: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
respiratory compliance
Comparison of measured respiratory compliance
Measured: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
applied mechanical power
Comparison of calculated applied mechanical power from the ventilator
Measured: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
respiratory resistance
Comparison of measured respiratory resistance
Measured: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
heart rate
Comparison of measured heart rate
Measured: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
mean arterial pressure
Comparison of measured mean arterial pressure
Measured: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
central venous pressure
Comparison of measured central venous pressure
Measured: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
Concentration of plamatic cytokine levels
Plasmatic cytokine level of IL-6, IL-8, IL-10 and TNF-alpha will be assessed pre- (before induction of general anesthesia) and postoperative (ad PACU admission and 60 minutes therafter).
Measured: preoperative before induction of general anesthesia and postoperative at PACU admission and 1 hour thereafter
length of PACU stay
Duration of the patient at the post-anesthesia care unit (PACU)
Measured: Time from PACU admission to transfer to a general ward in hours
length of hospital stay
Comparison of length of hospital stay after thoracic surgery
Measured: days from surgery to hospital discharge
postoperative pulmonary complications (PPC)
PPC will be assessd daily until hospital discharge or day 30 of hospital stay from the medical records during the follow-up period. The European Perioperative Clinical Outcome (EPCO) definition will be used to assess the occurrence of PPC.
Measured: until hospital discharge or day 30 of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start29 Oct 2020
- Primary completion16 Feb 2022
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Positive-Pressure Respiration, IntrinsicStudies 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
- Parallel groups
- Model description
- controlled, prospective
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith Martini, MD, Principal investigator, Medical University Innsbruck, Dept. of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534933
- Sponsor's protocol ID
- 1014/2020
- Status last verified
- Feb 2020
- First submitted
- 13 Aug 2020
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
PubMed 25058504Schmidt J, Wenzel C, Mahn M, Spassov S, Cristina Schmitz H, Borgmann S, Lin Z, Haberstroh J, Meckel S, Eiden S, Wirth S, Buerkle H, Schumann S. Improved lung recruitment and oxygenation during mandatory ventilation with a new expiratory ventilation assistance device: A controlled interventional trial in healthy pigs. Eur J Anaesthesiol. 2018 Oct;35(10):736-744. doi: 10.1097/EJA.0000000000000819.
PubMed 29734208Weber J, Schmidt J, Straka L, Wirth S, Schumann S. Flow-controlled ventilation improves gas exchange in lung-healthy patients- a randomized interventional cross-over study. Acta Anaesthesiol Scand. 2020 Apr;64(4):481-488. doi: 10.1111/aas.13526. Epub 2019 Dec 30.
PubMed 31828755Weber J, Straka L, Borgmann S, Schmidt J, Wirth S, Schumann S. Flow-controlled ventilation (FCV) improves regional ventilation in obese patients - a randomized controlled crossover trial. BMC Anesthesiol. 2020 Jan 28;20(1):24. doi: 10.1186/s12871-020-0944-y.
PubMed 31992213
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Controlled Ventilation Versus Pressure Controlled Ventilation in Thoracic Surgery With One Lung Ventilation - a Prospective, Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT04534933
- Acronym / sponsor ID
- 1014/2020
- Conditions
- Positive-Pressure Respiration, Intrinsic
- Keywords
- flow controlled ventilation, pressure controlled ventilation, thoracic surgery, one lung ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 1 Sep 2020 (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.
This trial investigates effects of individualized (by compliance guided pressure settings) flow-controlled ventilation compared to best clinical practice pressure-controlled ventilation in thoracic surgery requiring one lung ventilation.
Detailed description
Flow-controlled ventilation (FCV) is a novel ventilation method with promising first results in porcine studies as well as clinical cross-over trials. A more efficient and maybe lung protective ventilation strategy would be crucial in the challenging situation of one lung ventilation during thoracic surgery, when the whole gas exchange has to be provided by just one half of the lungs.
Thus, individualized FCV, based on compliance guided pressure settings, will be compared to standard of pressure-controlled ventilation in thoracic surgery requiring one lung ventilation in a randomized controlled trial. Based on previous preclinical trials an improvement of oxygenation by 15% will be expected and in order to transfer the preclinical results to humans oxygenation assessed by paO2 / FiO2 ratio after 30 minutes of one lung ventilation is the main primary outcome parameter of this study. Furthermore, improved recruitment of lung tissue due to controlled expiratory flow in FCV will be anticipated without the need of recruitment maneuvers, which may cause deleterious effects on lung tissue. Accordingly any recruitment maneuvers will be omitted in the FCV group.
The investigators hypothesize that improved gas exchange in terms of improved oxygenation and reduced respiratory minute volume required for CO2-removal will be achieved with FCV compared to PCV. Secondary outcome parameters such as the incidence of postoperative pulmonary complications will be additionally assessed in order to plan future studies with clinically relevant outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- controlled, prospective
| Arm | Type | Receives |
|---|---|---|
| FCV | Experimental | Device: EvoneArtificial ventilation will be performed with individualized flow-controlled ventilation (Evone, Ventinova Medical B.V., Eindhoven, the Netherlands) during thoracic surgery. Individualization will be established by compliance guided end-expiratory and peak pressure setting during two lung ventilation as well as one lung ventilation, flow setting will be adjusted to secure normocapnia during two lung ventilation and the targeted paCO2 during one lung ventilation is 40-60 mmHg, provided that pH >7.2. The I:E ratio will be set to 1:1. The FiO2 will be set to achieve normoxia during two lung ventilation, increased to 100% before lung isolation and after 15 minutes of one-lung ventilation again decreased to secure normoxia or mild hyperoxia (target paO2 of 75-120 mmHg). No recruitment maneuver will be performed for re-inflation of the separated lung and after regain of spontaneous breathing tracheal extubation performed in the operating room. |
| PCV | Active comparator | Device: PrimusArtificial ventilation will be performed with pressure-controlled ventilation (Primus, Dräger, Lübeck, Germany) during thoracic surgery. Peak pressure will be set to achieve a tidal volume of 6-8 ml/kg predicted body weight (PBW) at a compliance titrated positive end-expiratory pressure during two lung ventilation and the tidal volume will be reduced to 4-6 ml/kg PBW during one lung ventilation. Respiratory rate will be set to maintain normocapnia during two lung ventilation and a targeted paCO2 level during one lung ventilation of 40-60 mmHg, provided that pH > 7.2. The I:E ratio will be set to 1:1.5 except extension of expiration is necessary in order to avoid air trapping. The FiO2 will be set to achieve normoxia during two lung ventilation, increased to 100% before lung isolation until 15 minutes of one lung ventilation and decreased thereafter to achieve a targeted paO2 level of 75-120 mmHg. For re-inflation a manual recruitment maneuver will be performed under surgical guidance. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects ≥ 18 years
- Body weight ≥ 40 kg
- Elective thoracic surgery requiring OLV
- ASA I-III
- Written informed consent
Key exclusion criteria (6 listed)
- Emergency surgery
- Female subjects known to be pregnant
- Known participation in another interventional clinical trial
- high pulmonary risk (ppo FEV1<20ml/kg in male or ppo FEV1<18ml/kg in female)
- Empyema evacuation or signs of pulmonary infection
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 |
|---|---|---|
| EvoneAirway ventilation device | Device | FCV |
| PrimusAirway ventilation device | Device | PCV |
Primary outcome
paO2 / FiO2 ratio (Horowitz Index)
Time frame: after 30 minutes of one lung ventilation
Comparison of oxygenation assessed by arterial partial pressure of oxygen (paO2) / fraction of inspired oxygen (FiO2)
18 secondary outcomes
decarboxylation (paCO2)
Time frame: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
venous admixture (Qs / Qt)
Time frame: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
respiratory minute volume
Time frame: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
respiratory rate
Time frame: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
tidal volume
Time frame: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
positive end-expiratory pressure
Time frame: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
peak pressure
Time frame: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
driving pressure
Time frame: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
respiratory compliance
Time frame: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
applied mechanical power
Time frame: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
respiratory resistance
Time frame: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
heart rate
Time frame: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
mean arterial pressure
Time frame: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
central venous pressure
Time frame: during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
Concentration of plamatic cytokine levels
Time frame: preoperative before induction of general anesthesia and postoperative at PACU admission and 1 hour thereafter
length of PACU stay
Time frame: Time from PACU admission to transfer to a general ward in hours
length of hospital stay
Time frame: days from surgery to hospital discharge
postoperative pulmonary complications (PPC)
Time frame: until hospital discharge or day 30 of hospital stay
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 16 Dec 2024.
- Background: PubMed 25058504Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
- Background: PubMed 29734208Schmidt J, Wenzel C, Mahn M, Spassov S, Cristina Schmitz H, Borgmann S, Lin Z, Haberstroh J, Meckel S, Eiden S, Wirth S, Buerkle H, Schumann S. Improved lung recruitment and oxygenation during mandatory ventilation with a new expiratory ventilation assistance device: A controlled interventional trial in healthy pigs. Eur J Anaesthesiol. 2018 Oct;35(10):736-744. doi: 10.1097/EJA.0000000000000819.
- Background: PubMed 31828755Weber J, Schmidt J, Straka L, Wirth S, Schumann S. Flow-controlled ventilation improves gas exchange in lung-healthy patients- a randomized interventional cross-over study. Acta Anaesthesiol Scand. 2020 Apr;64(4):481-488. doi: 10.1111/aas.13526. Epub 2019 Dec 30.
- Background: PubMed 31992213Weber J, Straka L, Borgmann S, Schmidt J, Wirth S, Schumann S. Flow-controlled ventilation (FCV) improves regional ventilation in obese patients - a randomized controlled crossover trial. BMC Anesthesiol. 2020 Jan 28;20(1):24. doi: 10.1186/s12871-020-0944-y.
- Individual participant dataSharing planned: No
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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.
Judith Martini, MD principal investigator
Medical University Innsbruck, Dept. of Anaesthesiology
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 and Primus in people with Positive-Pressure Respiration, Intrinsic, 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 5 inclusion and 6 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 16 Dec 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?
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?
paO2 / FiO2 ratio (Horowitz Index) (time frame: after 30 minutes of one lung ventilation). 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 NCT04534933, which also lists 4 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 16 Dec 2024.