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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventor | Experimental | Subjects being treated with Ventor device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resuscitation (Ventor) | Device | Resuscitation with the Ventor device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability to provide oxygenation during CPR | As measured through the monitoring of intra-arrest PaO2 | From device insertion through 1 hour. |
| Ability to provide ventilation during CPR | As measured through the monitoring of intra-arrest PaCO2 | From device insertion through 1 hour |
| Ability to provide oxygenation during CPR | As measured through the monitoring of intra-arrest cerebral oximetry | From device insertion through 1 hour |
| Number of participants with device-related adverse events | Number and rate of adverse events | From device insertion through 3 months |
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Inclusion Criteria:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clay Nolan | Contact | (800) 592-6241 | clayn@colabsmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Jignesh Patel, M.D., M.Sc. | Stony Brook University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University Hospital | Recruiting | Stony Brook | New York | 11794 | United States |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012151 | Resuscitation |
| ID | Term |
|---|---|
| D004638 | Emergency Treatment |
| D013812 | Therapeutics |
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