Out-of-Hospital Cardiac ArrestCAventNCT04237727
CAvent-Ventilation During Advanced Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest- an Observational Study
An observational study of Out-of-Hospital Cardiac Arrest and Pulmonary Ventilation, run by Uppsala University at 5 sites in 2 countries.
Trial summary
The aim of this observational study is to investigate how ventilations is given during cardiopulmonary resuscitation (CPR) given by advanced life support providers (ALS). A portable device capable of detailed measurments of ventilation will be used when ventilating patients suffering cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest, Pulmonary Ventilation
- What is being tested?
- Fluxmed GrH portable pneumotachograph
- Type of treatment
- Medical device
- How many people
- 241 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 May 2019to 1 Dec 2025
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients suffering sudden cardic arrest treated with CPR by ALS-providers in Uppsala, Amsterdam, Stockholm and Falun county hospital.
Who may be able to join
- Out-of-hospital cardiac arrest (OHCA) treated with CPR performed by the EMS personnel
Who cannot join
- Patient age < 18 years
- Known pregnancy
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Sweden3 sites
Falun county hospital
Falun
Capio AB Rapid Response Cars
Stockholm
Uppsala University hospital
Uppsala, 75185
Netherlands2 sites
Regionale Ambulance Voorziening Utrecht, Netherlands
Amersfoort, Utrecht
Amsterdam UMC
Amsterdam
About this study
The aim of this observational study is to investigate how ventilations is given during cardiopulmonary resuscitation (CPR) given by advanced life support providers (ALS). A portable device capable of detailed measurments of ventilation will be used when ventilating patients suffering cardiac arrest.
The main objective of the study is to describe the ventilatiosn given in terms of volume, frequency and pressure, both overall and during different CPR modes and when using different methods to handle the patients airway.
Read the detailed description
The aim with this observational multicenter study is to measure and describe manual ventilation during cardiopulmonary resuscitation in the advance life support setting.
Primary endpoint is the ventilation quality measured as ventilation frequency, tidal volume, minute ventilation peak inspiratory pressure and exhaled CO2.
This will be studied in both asycnhronous ventilations, meaning ventilations that are given during ongoing chest compressions and syncrhonous ventilations, meaning ventilations given during a pause of the chest compressions, in a 30:2 repeatign pattern. Aditionally, airway modalities such as bag-valve-masks, Supraglottic airway devices and endotracheal tubes will be studied.
The inclusion of patients will be performed at five sites, The Uppsala emergency medical services, Uppsala, Sweden, Capio AB akutläkarbilar (rapid response cars), Stockholm Sweden, Falun County hospital, Falun, Sweden, EMS Amsterdam post West, Amsterdam, The Netherlands and Lifeliner 1 HEMS, Amsterdam, The Netherlands Eligible for inclusion are patients over 18 years old suffering cardiac arrest in the areas served by the including emergency medical systems and in-hospital emergency team.
The goal is to include at least 200 patients.
- Being tested
- Fluxmed GrH portable pneumotachograph
- Keywords
- Out-of-Hospital Cardiac Arrest, Cardiopulmonary Resuscitation, Respiration, Artificial
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluxmed GrH portable pneumotachographDevice
Fluxmed GrH portable pneumotachograph is used to measure the given ventilation. It is placed on the chosen airway adjunct and passively measures ventilation parameters such as volumes, and flow.
| Study group | Role | What they receive |
|---|---|---|
| Patient recieving asycnhronous ventilations | Not described Receives: Device: Fluxmed GrH portable pneumotachograph | |
| Patient recieving synchronous ventilations | Not described Receives: Device: Fluxmed GrH portable pneumotachograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation frequency
Measured as ventilations per minute.
Measured: 1 Day
Tidal volume
Measured as milliliters per ventilation.
Measured: 1 Day
Minute Ventilation
Measured as litres per minute.
Measured: 1 Day
Secondary outcomes (5)
Variation of etCO2 in relation to different ratios of compression to ventilations
etCO2 measured as kilopascal for each exhalation during CPR with 30 compressions and 2 ventilations and during continous compressions and ventilations.
Measured: 1 Day
Time of inspiration
Measured as seconds for each inspiration.
Measured: 1 Day
Fraction of dead space ventilation
Dead space measured as milliliters for each ventilation compared to the tidal volume in milliters for that same ventilation.
Measured: 1 Day
Peak inspiratory pressure during ventilation
Measured as cmH20 for each ventilation.
Measured: 1 Day
Return of spontaneous circulation
If the patient, as stated by the ALS provider, has spontaneous circultation during the resuscitation attempt
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 May 2019
- Primary completion31 Aug 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Regionale Ambulance Voorziening, Amersfoort, Utrecht, Netherlands, Amsterdam UMC, Dalarna County Hospital, Falun, Sweden, Capio AB Rapid Response Cars, Stockholm, Sweden
- Responsible party
- Principal investigator, Sten Rubertsson, Uppsala University
- Investigators
- Sten Rubertsson, PhD, Principal investigator, Uppsala University department of surgical sciencesDavid Smekal, PhD, Study chair, Uppsala University department of surgical sciencesJohan Mällberg, BsSC, Study chair, Uppsala University department of surgical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237727
- Sponsor's protocol ID
- VENT001
- Acronym
- CAvent
- Status last verified
- Mar 2026
- First submitted
- 4 Apr 2019
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perkins GD, Handley AJ, Koster RW, Castren M, Smyth MA, Olasveengen T, Monsieurs KG, Raffay V, Grasner JT, Wenzel V, Ristagno G, Soar J; Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation. Resuscitation. 2015 Oct;95:81-99. doi: 10.1016/j.resuscitation.2015.07.015. Epub 2015 Oct 15. No abstract available.
PubMed 26477420Nizhenkovska IV, Pidchenko VT, Bychkova NG, Bisko NA, Rodnichenko AY, Kozyko NO. Influence of Ganoderma lucidum (Curt.: Fr.) P. Karst. on T-cell-mediated immunity in normal and immunosuppressed mice line CBA/Ca. Ceska Slov Farm. 2015 Sep;64(4):139-43.
PubMed 26459128Hollenberg J, Svensson L, Rosenqvist M. Out-of-hospital cardiac arrest: 10 years of progress in research and treatment. J Intern Med. 2013 Jun;273(6):572-83. doi: 10.1111/joim.12064. Epub 2013 Apr 1.
PubMed 23480824Grasner JT, Lefering R, Koster RW, Masterson S, Bottiger BW, Herlitz J, Wnent J, Tjelmeland IB, Ortiz FR, Maurer H, Baubin M, Mols P, Hadzibegovic I, Ioannides M, Skulec R, Wissenberg M, Salo A, Hubert H, Nikolaou NI, Loczi G, Svavarsdottir H, Semeraro F, Wright PJ, Clarens C, Pijls R, Cebula G, Correia VG, Cimpoesu D, Raffay V, Trenkler S, Markota A, Stromsoe A, Burkart R, Perkins GD, Bossaert LL; EuReCa ONE Collaborators. Corrigendum to "EuReCa ONE-27 Nations, ONE Europe, ONE Registry A prospective one month analysis of out-of-hospital cardiac arrest outcomes in 27 countries in Europe" [Resuscitation 105 (2016) 188-195]. Resuscitation. 2016 Dec;109:145-146. doi: 10.1016/j.resuscitation.2016.10.001. Epub 2016 Oct 15. No abstract available.
PubMed 27750053Kern KB, Hilwig RW, Berg RA, Sanders AB, Ewy GA. Importance of continuous chest compressions during cardiopulmonary resuscitation: improved outcome during a simulated single lay-rescuer scenario. Circulation. 2002 Feb 5;105(5):645-9. doi: 10.1161/hc0502.102963.
PubMed 11827933Pollack RA, Brown SP, Rea T, Aufderheide T, Barbic D, Buick JE, Christenson J, Idris AH, Jasti J, Kampp M, Kudenchuk P, May S, Muhr M, Nichol G, Ornato JP, Sopko G, Vaillancourt C, Morrison L, Weisfeldt M; ROC Investigators. Impact of Bystander Automated External Defibrillator Use on Survival and Functional Outcomes in Shockable Observed Public Cardiac Arrests. Circulation. 2018 May 15;137(20):2104-2113. doi: 10.1161/CIRCULATIONAHA.117.030700. Epub 2018 Feb 26.
PubMed 29483086Nolan JP, Soar J, Zideman DA, Biarent D, Bossaert LL, Deakin C, Koster RW, Wyllie J, Bottiger B; ERC Guidelines Writing Group. European Resuscitation Council Guidelines for Resuscitation 2010 Section 1. Executive summary. Resuscitation. 2010 Oct;81(10):1219-76. doi: 10.1016/j.resuscitation.2010.08.021. No abstract available.
PubMed 20956052Perkins GD, Olasveengen TM, Maconochie I, Soar J, Wyllie J, Greif R, Lockey A, Semeraro F, Van de Voorde P, Lott C, Monsieurs KG, Nolan JP; European Resuscitation Council. European Resuscitation Council Guidelines for Resuscitation: 2017 update. Resuscitation. 2018 Feb;123:43-50. doi: 10.1016/j.resuscitation.2017.12.007. Epub 2017 Dec 9. No abstract available.
PubMed 29233740Becker TK, Berning AW, Prabhu A, Callaway CW, Guyette FX, Martin-Gill C. An assessment of ventilation and perfusion markers in out-of-hospital cardiac arrest patients receiving mechanical CPR with endotracheal or supraglottic airways. Resuscitation. 2018 Jan;122:61-64. doi: 10.1016/j.resuscitation.2017.11.054. Epub 2017 Nov 23.
PubMed 29175355Axelsson C, Karlsson T, Axelsson AB, Herlitz J. Mechanical active compression-decompression cardiopulmonary resuscitation (ACD-CPR) versus manual CPR according to pressure of end tidal carbon dioxide (P(ET)CO2) during CPR in out-of-hospital cardiac arrest (OHCA). Resuscitation. 2009 Oct;80(10):1099-103. doi: 10.1016/j.resuscitation.2009.08.006. Epub 2009 Aug 28.
PubMed 19716640
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAvent-Ventilation During Advanced Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest- an Observational Study
- ClinicalTrials.gov ID
- NCT04237727
- Acronym / sponsor ID
- CAvent / VENT001
- Keywords
- Out-of-Hospital Cardiac Arrest, Cardiopulmonary Resuscitation, Respiration, Artificial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Regionale Ambulance Voorziening, Amersfoort, Utrecht, Netherlands, Amsterdam UMC, Dalarna County Hospital, Falun, Sweden, Capio AB Rapid Response Cars, Stockholm, Sweden
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 23 Jan 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.
The aim of this observational study is to investigate how ventilations is given during cardiopulmonary resuscitation (CPR) given by advanced life support providers (ALS). A portable device capable of detailed measurments of ventilation will be used when ventilating patients suffering cardiac arrest.
The main objective of the study is to describe the ventilatiosn given in terms of volume, frequency and pressure, both overall and during different CPR modes and when using different methods to handle the patients airway.
Detailed description
The aim with this observational multicenter study is to measure and describe manual ventilation during cardiopulmonary resuscitation in the advance life support setting.
Primary endpoint is the ventilation quality measured as ventilation frequency, tidal volume, minute ventilation peak inspiratory pressure and exhaled CO2.
This will be studied in both asycnhronous ventilations, meaning ventilations that are given during ongoing chest compressions and syncrhonous ventilations, meaning ventilations given during a pause of the chest compressions, in a 30:2 repeatign pattern. Aditionally, airway modalities such as bag-valve-masks, Supraglottic airway devices and endotracheal tubes will be studied.
The inclusion of patients will be performed at five sites, The Uppsala emergency medical services, Uppsala, Sweden, Capio AB akutläkarbilar (rapid response cars), Stockholm Sweden, Falun County hospital, Falun, Sweden, EMS Amsterdam post West, Amsterdam, The Netherlands and Lifeliner 1 HEMS, Amsterdam, The Netherlands Eligible for inclusion are patients over 18 years old suffering cardiac arrest in the areas served by the including emergency medical systems and in-hospital emergency team.
The goal is to include at least 200 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient recieving asycnhronous ventilations | – | Device: Fluxmed GrH portable pneumotachograph |
| Patient recieving synchronous ventilations | – | Device: Fluxmed GrH portable pneumotachograph |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients suffering sudden cardic arrest treated with CPR by ALS-providers in Uppsala, Amsterdam, Stockholm and Falun county hospital.
Key inclusion criteria (1 listed)
- Out-of-hospital cardiac arrest (OHCA) treated with CPR performed by the EMS personnel
Key exclusion criteria (2 listed)
- Patient age < 18 years
- Known pregnancy
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 |
|---|---|---|
| Fluxmed GrH portable pneumotachographFluxmed GrH portable pneumotachograph is used to measure the given ventilation. It is placed on the chosen airway adjunct and passively measures ventilation parameters such as volumes, and flow. | Device | Patient recieving asycnhronous ventilations, Patient recieving synchronous ventilations |
Primary outcome
Ventilation frequency
Time frame: 1 Day
Measured as ventilations per minute.
Tidal volume
Time frame: 1 Day
Measured as milliliters per ventilation.
Minute Ventilation
Time frame: 1 Day
Measured as litres per minute.
5 secondary outcomes
Variation of etCO2 in relation to different ratios of compression to ventilations
Time frame: 1 Day
Time of inspiration
Time frame: 1 Day
Fraction of dead space ventilation
Time frame: 1 Day
Peak inspiratory pressure during ventilation
Time frame: 1 Day
Return of spontaneous circulation
Time frame: 1 Day
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 7 Apr 2026.
- Background: PubMed 26477420Perkins GD, Handley AJ, Koster RW, Castren M, Smyth MA, Olasveengen T, Monsieurs KG, Raffay V, Grasner JT, Wenzel V, Ristagno G, Soar J; Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation. Resuscitation. 2015 Oct;95:81-99. doi: 10.1016/j.resuscitation.2015.07.015. Epub 2015 Oct 15. No abstract available.
- Background: PubMed 26459128Nizhenkovska IV, Pidchenko VT, Bychkova NG, Bisko NA, Rodnichenko AY, Kozyko NO. Influence of Ganoderma lucidum (Curt.: Fr.) P. Karst. on T-cell-mediated immunity in normal and immunosuppressed mice line CBA/Ca. Ceska Slov Farm. 2015 Sep;64(4):139-43.
- Background: PubMed 23480824Hollenberg J, Svensson L, Rosenqvist M. Out-of-hospital cardiac arrest: 10 years of progress in research and treatment. J Intern Med. 2013 Jun;273(6):572-83. doi: 10.1111/joim.12064. Epub 2013 Apr 1.
- Background: PubMed 27750053Grasner JT, Lefering R, Koster RW, Masterson S, Bottiger BW, Herlitz J, Wnent J, Tjelmeland IB, Ortiz FR, Maurer H, Baubin M, Mols P, Hadzibegovic I, Ioannides M, Skulec R, Wissenberg M, Salo A, Hubert H, Nikolaou NI, Loczi G, Svavarsdottir H, Semeraro F, Wright PJ, Clarens C, Pijls R, Cebula G, Correia VG, Cimpoesu D, Raffay V, Trenkler S, Markota A, Stromsoe A, Burkart R, Perkins GD, Bossaert LL; EuReCa ONE Collaborators. Corrigendum to "EuReCa ONE-27 Nations, ONE Europe, ONE Registry A prospective one month analysis of out-of-hospital cardiac arrest outcomes in 27 countries in Europe" [Resuscitation 105 (2016) 188-195]. Resuscitation. 2016 Dec;109:145-146. doi: 10.1016/j.resuscitation.2016.10.001. Epub 2016 Oct 15. No abstract available.
- Background: PubMed 11827933Kern KB, Hilwig RW, Berg RA, Sanders AB, Ewy GA. Importance of continuous chest compressions during cardiopulmonary resuscitation: improved outcome during a simulated single lay-rescuer scenario. Circulation. 2002 Feb 5;105(5):645-9. doi: 10.1161/hc0502.102963.
- Background: PubMed 29483086Pollack RA, Brown SP, Rea T, Aufderheide T, Barbic D, Buick JE, Christenson J, Idris AH, Jasti J, Kampp M, Kudenchuk P, May S, Muhr M, Nichol G, Ornato JP, Sopko G, Vaillancourt C, Morrison L, Weisfeldt M; ROC Investigators. Impact of Bystander Automated External Defibrillator Use on Survival and Functional Outcomes in Shockable Observed Public Cardiac Arrests. Circulation. 2018 May 15;137(20):2104-2113. doi: 10.1161/CIRCULATIONAHA.117.030700. Epub 2018 Feb 26.
- Background: PubMed 20956052Nolan JP, Soar J, Zideman DA, Biarent D, Bossaert LL, Deakin C, Koster RW, Wyllie J, Bottiger B; ERC Guidelines Writing Group. European Resuscitation Council Guidelines for Resuscitation 2010 Section 1. Executive summary. Resuscitation. 2010 Oct;81(10):1219-76. doi: 10.1016/j.resuscitation.2010.08.021. No abstract available.
- Background: PubMed 29233740Perkins GD, Olasveengen TM, Maconochie I, Soar J, Wyllie J, Greif R, Lockey A, Semeraro F, Van de Voorde P, Lott C, Monsieurs KG, Nolan JP; European Resuscitation Council. European Resuscitation Council Guidelines for Resuscitation: 2017 update. Resuscitation. 2018 Feb;123:43-50. doi: 10.1016/j.resuscitation.2017.12.007. Epub 2017 Dec 9. No abstract available.
- Background: PubMed 29175355Becker TK, Berning AW, Prabhu A, Callaway CW, Guyette FX, Martin-Gill C. An assessment of ventilation and perfusion markers in out-of-hospital cardiac arrest patients receiving mechanical CPR with endotracheal or supraglottic airways. Resuscitation. 2018 Jan;122:61-64. doi: 10.1016/j.resuscitation.2017.11.054. Epub 2017 Nov 23.
- Background: PubMed 19716640Axelsson C, Karlsson T, Axelsson AB, Herlitz J. Mechanical active compression-decompression cardiopulmonary resuscitation (ACD-CPR) versus manual CPR according to pressure of end tidal carbon dioxide (P(ET)CO2) during CPR in out-of-hospital cardiac arrest (OHCA). Resuscitation. 2009 Oct;80(10):1099-103. doi: 10.1016/j.resuscitation.2009.08.006. Epub 2009 Aug 28.
- Hjärt-lungräddningsregistret årsrapport 2017. Stockholm: HLR rådetLink provided by the sponsor.
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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.
Sten Rubertsson, PhD principal investigator
Uppsala University department of surgical sciences
David Smekal, PhD study chair
Uppsala University department of surgical sciences
Johan Mällberg, BsSC study chair
Uppsala University department of surgical sciences
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-of-Hospital Cardiac Arrest and Pulmonary Ventilation, run by Uppsala University at 5 sites in 2 countries.
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 1 inclusion and 2 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden, 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?
Ventilation frequency (time frame: 1 Day). The study lists 3 primary outcomes in all. 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 NCT04237727, which also lists 10 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 7 Apr 2026.