CCSV - Post Market Clinical Follow-up Study

NCT ID: NCT06836908

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Arrest

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IPPV

Cardiac arrest patients ventilated with IPPV

No interventions assigned to this group

CCSV

Cardiac arrest patients ventilated with CCSV

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role lead

WEINMANN Emergency, Medical Technology GmbH & Co. KG

UNKNOWN

Sponsor Role collaborator

Berufsrettung Wien

UNKNOWN

Sponsor Role collaborator

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sebastian Schnaubelt, MD

Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sebastian Schnaubelt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Emergency Medicine, Medical University of Vienna

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of Vienna

Vienna, Austria, Austria

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Austria

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sebastian Schnaubelt, MD, PhD

Role: CONTACT

+43 1 40400 ext. 19640

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sebastian Schnaubelt, MD, PhD

Role: primary

+43 1 40400 19640

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CCSV 1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ventilation Monitoring in OHCA
NCT04988906 COMPLETED NA
The VENTOR Clinical Study
NCT06759389 RECRUITING NA