Cardiac Arrest (CA)
Conditions
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.
Interventions
DEVICEResuscitation (Ventor)
Resuscitation with the Ventor device
Sponsors
CoLabs Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18-75 years, inclusive 2. IHCA (non-traumatic) 3. At least 4 feet in height
Exclusion criteria
1. Intubated with an endotracheal tube (ET) 2. Valid do-not-attempt-resuscitation (DNAR) or study opt-out bracelet (including previous enrollment bracelet) 3. LAR or Family member objects to enrollment 4. Obvious signs of irreversible death (rigor mortis, dependent lividity, decapitation, transection, decomposition) 5. Responsive with an intact gag reflex 6. Blunt, penetrating, or burn-related injury, drowning, or electrocution 7. Known upper airway foreign body or mass 8. Lower airway obstruction 9. Dental gap of \< 2 cm 10. Ingested caustic substances 11. Medicine Admitting Note's medical history is incomplete or has only been completed by an emergency physician. 12. Known esophageal disease or facial/perforating neck trauma defined as study candidates with the following medical history: 1. Diseases: (Esophageal Varices, Esophageal Cancer, Esophageal Strictures) 2. Any patient on the following medications will be excluded: (Oxaliplatin, Leucovorin, Fluorouracil) 3. Any patient with the following examination findings will be excluded: (Caput medusae, History or evidence of vomiting blood) 13. Known vulnerable subject other Inclusion #3, such as known (e.g.: prisoner, pregnancy, terminal illness, dementia) 14. History of medical, surgical or other conditions that, in the opinion of the investigator, would limit study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to provide oxygenation during CPR | From device insertion through 1 hour. | As measured through the monitoring of intra-arrest PaO2 |
| Ability to provide ventilation during CPR | From device insertion through 1 hour | As measured through the monitoring of intra-arrest PaCO2 |
| Number of participants with device-related adverse events | From device insertion through 3 months | Number and rate of adverse events |
Countries
United States
Contacts
Primary ContactClay Nolan
Outcome results
None listed