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Completed

NCT Number: NCT06836908

CCSV - 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.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Oxygenation

    Time frame: 24 months

    Difference in PaO2 between IPPV and CCSV group

Secondary outcomes

  1. Decarboxylation

    Time frame: 24 months

    Difference in PaCO2 between IPPV and CCSV group

  2. systemic perfusion

    Time frame: 24 months

    differences between IPPV and CCSV in cerebral oxygenation measured by near-infrared spectroscopy (NIRS)

  3. patient outcome

    Time frame: 27 months

    sustained return of spontaneous circulation (ROSC)

  4. ventilator-associated adverse events

    Time frame: 27 months

    Pneumothorax (until hospital admission)

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Berufsrettung Wien
  • WEINMANN Emergency, Medical Technology GmbH & Co. KG

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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