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

NCT ID: NCT04237727

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-29

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Out-of-Hospital Cardiac Arrest Pulmonary Ventilation

Keywords

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Out-of-Hospital Cardiac Arrest Cardiopulmonary Resuscitation Respiration, Artificial

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Fluxmed GrH will be used to measure the ventilation parameters

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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regionale Ambulance Voorziening, Amersfoort, Utrecht, Netherlands

UNKNOWN

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Sten Rubertsson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sten Rubertsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University department of surgical sciences

David Smekal, PhD

Role: STUDY_CHAIR

Uppsala University department of surgical sciences

Johan Mällberg, BsSC

Role: STUDY_CHAIR

Uppsala University department of surgical sciences

René Boomars, MSc

Role: STUDY_CHAIR

Regionale Ambulance Voorziening Utrecht (RAVU)

Thijs Verhagen, MD

Role: STUDY_CHAIR

Regionale Ambulance Voorziening Utrecht (RAVU)

Locations

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Regionale Ambulance Voorziening Utrecht, Netherlands

Amersfoort, Utrecht, Netherlands

Site Status RECRUITING

Uppsala University hospital

Uppsala, , Sweden

Site Status RECRUITING

Countries

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Netherlands Sweden

Central Contacts

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Sten Rubertsson, PhD

Role: CONTACT

Phone: +46708693996

Email: [email protected]

Johan Mällberg, B.Sc

Role: CONTACT

Phone: +4670691 71 54

Email: [email protected]

Facility Contacts

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Renée Boomars

Role: primary

Sten Rubertsson, Phd

Role: primary

Johan Mälberg, B.Sc.

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 26477420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26459128 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23480824 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27750053 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11827933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29483086 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20956052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29233740 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29175355 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19716640 (View on PubMed)

Related Links

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https://hlr.se/

Hjärt-lungräddningsregistret årsrapport 2017. Stockholm: HLR rådet

Other Identifiers

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VENT001

Identifier Type: -

Identifier Source: org_study_id