CCSV - Post Market Clinical Follow-up Study

NCT06836908 | Recruiting DMC

• 1 other identifier: CCSV 1
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• Oxygenation

  Difference in PaO2 between IPPV and CCSV group

  24 months

Secondary Outcomes (4)

• Decarboxylation

  24 months

• systemic perfusion

  24 months

• patient outcome

  27 months

• ventilator-associated adverse events

  27 months

Study Arms (2)

IPPV

Cardiac arrest patients ventilated with IPPV

CCSV

Cardiac arrest patients ventilated with CCSV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult out-of-hospital cardiac arrest patients in Vienna

You may qualify if:

• 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.

You may not qualify if:

• 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
• Traumatic cardiac arrest
• Suspected or known pregnancy
• Clinically suspected (tension-)pneumothorax

Sponsors & Collaborators

• Medical University of Vienna: lead
• WEINMANN Emergency, Medical Technology GmbH & Co. KG: collaborator
• Berufsrettung Wien: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, Austria, 1090, Austria

RECRUITING

Related Links

• CCSV Whitepaper

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sebastian Schnaubelt, MD, PhD

  Department of Emergency Medicine, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Schnaubelt, MD, PhD

CONTACT

+43 1 40400; sebastian.schnaubelt@meduniwien.ac.at

Study Design

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

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: February 20, 2025
• Study Start: June 1, 2024
• Primary Completion: June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 20, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)