Resuscitation (Ventor): Resuscitation with the Ventor device
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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
Primary outcome measure(s)
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
Ability to provide oxygenation during CPR — From device insertion through 1 hour As measured through the monitoring of intra-arrest cerebral oximetry
Number of participants with device-related adverse events — From device insertion through 3 months Number and rate of adverse events
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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