Overview
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
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
- Medicine Admitting Note's medical history is incomplete or has only been completed by an emergency physician.
- Known esophageal disease or facial/perforating neck trauma defined as study
candidates with the following medical history:
- Diseases: (Esophageal Varices, Esophageal Cancer, Esophageal Strictures)
- Any patient on the following medications will be excluded: (Oxaliplatin, Leucovorin, Fluorouracil)
- Any patient with the following examination findings will be excluded: (Caput medusae, History or evidence of vomiting blood)
- Known vulnerable subject other Inclusion #3, such as known (e.g.: prisoner,
pregnancy, terminal illness, dementia)
- History of medical, surgical or other conditions that, in the opinion of the investigator, would limit study participation