NCT04237727

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

6.3 years

First QC Date

April 4, 2019

Last Update Submit

March 25, 2026

Conditions

Out-of-Hospital Cardiac ArrestPulmonary Ventilation

Keywords

Out-of-Hospital Cardiac ArrestCardiopulmonary ResuscitationRespiration, Artificial

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Variation of etCO2 in relation to different ratios of compression to ventilations

    From start of CPR to end of CPR.

  • Time of inspiration

    From start to end of CPR.

  • Fraction of dead space ventilation

    From start of CPR to end of CPR..

  • Peak inspiratory pressure during ventilation

    From start of CPR to end of CPR.

  • Return of spontaneous circulation

    During the resuscitation attempt

Study Arms (2)

Patient recieving asycnhronous ventilations

patients recieving synchronous ventilations

Device: Fluxmed GrH portable pneumotachograph

Patient recieving sycnhronous ventilations

Device: Fluxmed GrH portable pneumotachograph

Interventions

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.

Patient recieving asycnhronous ventilationsPatient recieving sycnhronous ventilations

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Out-of-hospital cardiac arrest (OHCA) treated with CPR performed by the EMS personnel

You may not qualify if:

  • Patient age \< 18 years
  • Known pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Regionale Ambulance Voorziening Utrecht, Netherlands

Amersfoort, Utrecht, Netherlands

Location

Uppsala University hospital

Uppsala, 75185, Sweden

Location

Related Publications (10)

  • 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.

    PMID: 26477420BACKGROUND

  • 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.

    PMID: 26459128BACKGROUND

  • 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.

    PMID: 23480824BACKGROUND

  • 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.

    PMID: 27750053BACKGROUND

  • 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.

    PMID: 11827933BACKGROUND

  • 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.

    PMID: 29483086BACKGROUND

  • 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.

    PMID: 20956052BACKGROUND

  • 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.

    PMID: 29233740BACKGROUND

  • 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.

    PMID: 29175355BACKGROUND

  • 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.

    PMID: 19716640BACKGROUND

Related Links

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestRespiratory Aspiration

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sten Rubertsson, PhD

    Uppsala University department of surgical sciences

    PRINCIPAL INVESTIGATOR

  • David Smekal, PhD

    Uppsala University department of surgical sciences

    STUDY CHAIR

  • Johan Mällberg, BsSC

    Uppsala University department of surgical sciences

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 4, 2019

First Posted

January 23, 2020

Study Start

May 1, 2019

Primary Completion

August 31, 2025

Study Completion

December 1, 2025

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

NL(1)SE(1)