CAvent-Ventilation During Advanced Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest- a Descriptive Study (CAvent)

The aim with this descriptive multicenter study is to examine the quality of the ventilation given by Emergency Medical Service (EMS) personnel during cardiopulmonary resuscitation (CPR).

Primary endpoint is the ventilation quality measured as ventilation frequency, tidal volume and minute ventilation.

This will primarily be studied during CPR with a 30 compression/2 ventilation ratio performed by the EMS personnel where the airway is managed with a supraglottic device but also in CPR with continuous ventilation (8-10 breaths/minute) after the airway management have been replaced with an endotracheal within the emergency room.

The inclusion of patients will be performed at two sites (Uppsala; Sweden and Utrecht; Holland), all out-of-hospital cardia arrest (OHCA) patients will receive care according to current CPR guidelines using mechanical chest compressions.

Study Overview

• Status: Recruiting
• Conditions: Out-of-Hospital Cardiac Arrest; Pulmonary Ventilation
• Intervention / Treatment: Device: Fluxmed GrH will be used to measure the ventilation parameters

Detailed Description

The inclusion is estimated to run over a two-year period to reach the goal of at least 200 patients. The study has been preceded by a trial period in an effort to solve any logistic and technical problems.

The study will be a prospective descriptive multicenter study where measurement of ventilation data will be sampled during CPR by EMS treating patients with OHCA. Any results from standard laboratory tests related to ventilation quality will be retracted from the patient medical journal systems. In addition to ventilatory variables measured as endpoints, secondary endpoints will also be outcome measures as any ROSC, survival and neurological outcome (mRS, GOS-E) measured at 30 days and at 6 months.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Sten Rubertsson, PhD; Phone Number: +46708693996; Email: sten.rubertsson@surgsci.uu.se
• Study Contact Backup: Name: Johan Mällberg, B.Sc; Phone Number: +4670691 71 54; Email: johan.mallberg@akademiska.se

Study Locations

• Netherlands
  • Utrecht
    • Amersfoort, Utrecht, Netherlands
      • Recruiting
      • Regionale Ambulance Voorziening Utrecht, Netherlands
      • Contact: Renée Boomars; Phone Number: +31646390073; Email: R.Boomars@ravu.nl
• Sweden
  • Uppsala, Sweden, 75185
    • Recruiting
    • Uppsala University Hospital
    • Contact: Sten Rubertsson, Phd; Phone Number: +46708693996; Email: sten.rubertsson@akademiska.se
    • Contact: Johan Mälberg, B.Sc.; Phone Number: +46706917154

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Study population will be patients who have suffered an OHCA with CPR started by EMS personnel in Uppsala; Sweden and Utrech, Amersfoort; Holland.

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
• Trauma related cardiac arrest (inc. hanging)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilation frequency	Measured as ventilations per minute.	From start of CPR to end of CPR.
Tidal volume	Measured as milliliters per ventilation.	From start of CPR to end of CPR.
Minute Ventilation	Measured as litres per minute.	From start of CPR to end of CPR.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From start of CPR to end of CPR.
Time of inspiration	Measured as seconds for each inspiration.	From start to end of CPR.
Fraction of dead space ventilation	Dead space measured as milliliters for each ventilation compared to the tidal volume in milliters for that same ventilation.	From start of CPR to end of CPR..
Peak inspiratory pressure during ventilation	Measured as cmH20 for each ventilation.	From start of CPR to end of CPR.
Survival rate	Number of patients that has survived after the cardiac arrest.	30 days post cardiac arrest
Neurological outcome	Measured with the modified Ranking Scale (mRS).	30 days post cardiac arrest
Neurological outcome	Measured with the Glascow Outcome Scale -Extended (GOS-E).	30 days post cardiac arrest.
Survival rate	Number of patients that has survived after the cardiac arrest..	6 months post cardiac arrest
Neurological outcome	Measured with the modified Ranking Scale (mRS).	6 months post cardiac arrest
Neurological outcome	Measured with the Glascow Outcome Scale -Extended (GOS-E).	6 months post cardiac arrest.

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Regionale Ambulance Voorziening, Amersfoort, Utrecht, Netherlands
• 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; Study Chair: René Boomars, MSc, Regionale Ambulance Voorziening Utrecht (RAVU); Study Chair: Thijs Verhagen, MD, Regionale Ambulance Voorziening Utrecht (RAVU)

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.

Helpful Links

• Hjärt-lungräddningsregistret årsrapport 2017. Stockholm: HLR rådet

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2019
• Primary Completion (Estimated): December 25, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cardiopulmonary Resuscitation; Respiration, Artificial; Out-of-Hospital Cardiac Arrest
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: VENT001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No