The VENTOR Clinical Study

CoLabs Medical

Status: Not yet enrolling

Conditions: Cardiac Arrest (CA)

Treatments: Device: Resuscitation (Ventor)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06759389

CIP 1.0

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Ventor

Experimental group

Description:

Subjects being treated with Ventor device

Treatment:

Device: Resuscitation (Ventor)