CCSV - Post Market Clinical Follow-up Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06836908

Enrollment

Registered

2025-02-20

Start date

2024-06-01

Completion date

2026-03-31

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Austria

Contacts

PRINCIPAL_INVESTIGATORSebastian Schnaubelt, MD, PhD

Department of Emergency Medicine, Medical University of Vienna

Outcome results