Chest Compression Synchronized Ventilation (CCSV) - An Exploratory Post Market Clinical Follow-up Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Oxygenation
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
IPPV
Cardiac arrest patients ventilated with IPPV
CCSV
Cardiac arrest patients ventilated with CCSV
Outcomes
Primary Outcomes
Oxygenation
Time Frame: 24 months
Difference in PaO2 between IPPV and CCSV group
Secondary Outcomes
- Decarboxylation(24 months)
- systemic perfusion(24 months)
- patient outcome(27 months)
- ventilator-associated adverse events(27 months)
Investigators
Sebastian Schnaubelt, MD
Adjunct Professor
Medical University of Vienna