CCSV - Post Market Clinical Follow-up Study

Chest Compression Synchronized Ventilation (CCSV) - an Exploratory Post Market Clinical Follow-up Study

The main goal of this observational study is the evaluation of Chest Compression Synchronized Ventilation (CCSV) regarding oxygenation in terms of PaO2 assessed by routine blood gas analysis, hemodynamic effects, 30-day outcome and safety in comparison to Intermittent Positive Pressure Ventilation (IPPV) as data in humans is sparse especially in direct comparison to other ventilation modes.

Cardiac arrest patients in Vienna, Austria will be preclinically randomized (IPPV and CCSV) and ventilated accordingly during CPR. Differences in oxygenation, decarboxylation, systemic perfusion and cerebral oxygenation, the patient's 30-day outcome as well as ventilator-associated adverse events (e.g., pneumothorax) will be recorded and analyzed.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest

• Study Type: Observational
• Enrollment (Estimated): 98

Contacts and Locations

• Study Contact: Name: Sebastian Schnaubelt, MD, PhD; Phone Number: 19640 +43 1 40400; Email: sebastian.schnaubelt@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Sebastian Schnaubelt, MD, PhD; Phone Number: +43 1 40400 19640; Email: sebastian.schnaubelt@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult out-of-hospital cardiac arrest patients in Vienna

Description

Inclusion Criteria:

• OHCA
• Correct endotracheal intubation (seen by capnography)
• The patient is being treated by the Vienna Emergency Medical Services within the scope of emergency ventilation.
• MEDUMAT Standard from Weinmann Emergency is used.
• Mechanical ventilation is performed according to the specified indications.

Exclusion Criteria:

• Patients eligible for eCPR (as defined by the standard operating procedure of the Emergency Medical Service Vienna)
• Patients recovering (reaching sustained ROSC) before starting mechanical ventilation or in the first three minutes of it
• Any other mechanical ventilation during the ongoing CPR before study inclusion
• Traumatic cardiac arrest
• Suspected or known pregnancy
• Clinically suspected (tension-)pneumothorax

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
IPPV; Cardiac arrest patients ventilated with IPPV
CCSV; Cardiac arrest patients ventilated with CCSV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation	Difference in PaO2 between IPPV and CCSV group	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decarboxylation	Difference in PaCO2 between IPPV and CCSV group	24 months
systemic perfusion	differences between IPPV and CCSV in cerebral oxygenation measured by near-infrared spectroscopy (NIRS)	24 months
patient outcome	sustained return of spontaneous circulation (ROSC)	27 months
ventilator-associated adverse events	Pneumothorax (until hospital admission)	27 months

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Berufsrettung Wien; WEINMANN Emergency, Medical Technology GmbH & Co. KG
• Investigators: Principal Investigator: Sebastian Schnaubelt, MD, PhD, Department of Emergency Medicine, Medical University of Vienna

Publications and helpful links

Helpful Links

• CCSV Whitepaper

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest
• Other Study ID Numbers: CCSV 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No