RecruitingNot ApplicableNCT06759389

The VENTOR Clinical Study

The VENTOR Clinical Study - VENTilation and Airway Optimization for Cardiac Arrest Resuscitation

Sponsor

CoLabs Medical

Enrollment

25 participants

Start Date

Apr 4, 2025

Study Type

INTERVENTIONAL

Conditions

Cardiac Arrest (CA)

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

Adults aged 18-75 years, inclusive
IHCA (non-traumatic)
At least 4 feet in height

Exclusion Criteria17

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