NCT06759389
Recruiting
N/A
The VENTOR Clinical Study - VENTilation and Airway Optimization for Cardiac Arrest Resuscitation
CoLabs Medical1 site in 1 country25 target enrollmentApril 4, 2025
ConditionsCardiac Arrest (CA)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiac Arrest (CA)
- Sponsor
- CoLabs Medical
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Ability to provide oxygenation during CPR
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
To evaluate the initial safety and effectiveness of the Ventor Airway System in providing short-term ventilation support in non-breathing subjects during cardiopulmonary resuscitation (CPR) and respiratory arrests.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults aged 18-75 years, inclusive
- •IHCA (non-traumatic)
- •At least 4 feet in height
Exclusion Criteria
- •Intubated with an endotracheal tube (ET)
- •Valid do-not-attempt-resuscitation (DNAR) or study opt-out bracelet (including previous enrollment bracelet)
- •LAR or Family member objects to enrollment
- •Obvious signs of irreversible death (rigor mortis, dependent lividity, decapitation, transection, decomposition)
- •Responsive with an intact gag reflex
- •Blunt, penetrating, or burn-related injury, drowning, or electrocution
- •Known upper airway foreign body or mass
- •Lower airway obstruction
- •Dental gap of \< 2 cm
- •Ingested caustic substances
Outcomes
Primary Outcomes
Ability to provide oxygenation during CPR
Time Frame: From device insertion through 1 hour
As measured through the monitoring of intra-arrest cerebral oximetry
Ability to provide ventilation during CPR
Time Frame: From device insertion through 1 hour
As measured through the monitoring of intra-arrest PaCO2
Number of participants with device-related adverse events
Time Frame: From device insertion through 3 months
Number and rate of adverse events
Study Sites (1)
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