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

Out-of-Hospital Cardiac Arrest Clinical Trial

— CAvent  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04237727
• Other study ID #: VENT001
• Status: Recruiting
• Start date: March 29, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: Uppsala University
• Contact: Sten Rubertsson, PhD
• Phone: +46708693996
• Email: sten.rubertsson[@]surgsci.uu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2024
• Est. primary completion date: December 25, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest
• Pulmonary Ventilation

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Netherlands	Regionale Ambulance Voorziening Utrecht, Netherlands	Amersfoort	Utrecht
Sweden	Uppsala University hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Regionale Ambulance Voorziening, Amersfoort, Utrecht, Netherlands

Countries where clinical trial is conducted

Netherlands,  Sweden, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilation frequency	Measured as ventilations per minute.	From start of CPR to end of CPR.
Primary	Tidal volume	Measured as milliliters per ventilation.	From start of CPR to end of CPR.
Primary	Minute Ventilation	Measured as litres per minute.	From start of CPR to end of CPR.
Secondary	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.
Secondary	Time of inspiration	Measured as seconds for each inspiration.	From start to end of CPR.
Secondary	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..
Secondary	Peak inspiratory pressure during ventilation	Measured as cmH20 for each ventilation.	From start of CPR to end of CPR.
Secondary	Survival rate	Number of patients that has survived after the cardiac arrest.	30 days post cardiac arrest
Secondary	Neurological outcome	Measured with the modified Ranking Scale (mRS).	30 days post cardiac arrest
Secondary	Neurological outcome	Measured with the Glascow Outcome Scale -Extended (GOS-E).	30 days post cardiac arrest.
Secondary	Survival rate	Number of patients that has survived after the cardiac arrest..	6 months post cardiac arrest
Secondary	Neurological outcome	Measured with the modified Ranking Scale (mRS).	6 months post cardiac arrest
Secondary	Neurological outcome	Measured with the Glascow Outcome Scale -Extended (GOS-E).	6 months post cardiac arrest.

External Links

•   Hjärt-lungräddningsregistret årsrapport 2017. Stockholm: HLR rådet