Ventor airway device for short-term ventilation during CPR

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The VENTOR Clinical Study is an interventional device trial testing the Ventor Airway System for short-term ventilation in non-breathing adults during in-hospital cardiopulmonary resuscitation and respiratory arrests. Eligible participants are adults aged 18 to 75 who experience a non-traumatic in-hospital cardiac arrest and meet airway and height criteria; patients already intubated or with do-not-attempt-resuscitation orders are excluded. The device is placed to deliver short-term ventilation support during resuscitation efforts with a primary focus on initial safety and effectiveness outcomes. Enrollment and procedures take place at Stony Brook University Hospital under sponsorship from CoLabs Medical.

Why it matters

Who can join: the full rules

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

Where it's running

• Stony Brook University Hospital
  Stony Brook, New York, United States Recruiting

Study contacts

• Principal investigator: Jignesh Patel, M.D., M.Sc. — Stony Brook University Hospital
• Study coordinator: Clay Nolan
• Email: clayn@colabsmedical.com
• Phone: (800) 592-6241

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.