- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04237727
CAvent-Ventilation During Advanced Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest- an Observational Study (CAvent)
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Amsterdam, Netherlands
- Amsterdam UMC
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Utrecht
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Amersfoort, Utrecht, Netherlands
- Regionale Ambulance Voorziening Utrecht, Netherlands
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Falun, Sweden
- Falun county hospital
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Stockholm, Sweden
- Capio AB Rapid Response Cars
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Uppsala, Sweden, 75185
- Uppsala University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Out-of-hospital cardiac arrest (OHCA) treated with CPR performed by the EMS personnel
Exclusion Criteria:
- Patient age < 18 years
- Known pregnancy
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patient recieving asycnhronous ventilations
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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.
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Patient recieving synchronous ventilations
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Ventilation frequency
Time Frame: 1 Day
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Measured as ventilations per minute.
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1 Day
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Tidal volume
Time Frame: 1 Day
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Measured as milliliters per ventilation.
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1 Day
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Minute Ventilation
Time Frame: 1 Day
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Measured as litres per minute.
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1 Day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Variation of etCO2 in relation to different ratios of compression to ventilations
Time Frame: 1 Day
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etCO2 measured as kilopascal for each exhalation during CPR with 30 compressions and 2 ventilations and during continous compressions and ventilations.
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1 Day
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Time of inspiration
Time Frame: 1 Day
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Measured as seconds for each inspiration.
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1 Day
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Fraction of dead space ventilation
Time Frame: 1 Day
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Dead space measured as milliliters for each ventilation compared to the tidal volume in milliters for that same ventilation.
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1 Day
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Peak inspiratory pressure during ventilation
Time Frame: 1 Day
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Measured as cmH20 for each ventilation.
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1 Day
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Return of spontaneous circulation
Time Frame: 1 Day
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If the patient, as stated by the ALS provider, has spontaneous circultation during the resuscitation attempt
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1 Day
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sten Rubertsson, PhD, Uppsala University department of surgical sciences
- Study Chair: David Smekal, PhD, Uppsala University department of surgical sciences
- Study Chair: Johan Mällberg, BsSC, Uppsala University department of surgical sciences
Publications and helpful links
General 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.
- Nizhenkovska 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.
- Hollenberg 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.
- Grasner 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.
- Kern 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.
- Pollack 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.
- Nolan 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.
- Perkins 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.
- Becker 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.
- Axelsson 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VENT001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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