Ventor airway device for short-term ventilation during CPR

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

This will test the Ventor Airway System to provide short-term breathing support during CPR for adults who have a non-traumatic in-hospital cardiac arrest.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: CoLabs Medical (Industry-sponsored)
• Locations: 1 site (Stony Brook, New York)
• Trial ID: NCT06759389 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are non-intubated adults aged 18–75 who suffer a non-traumatic in-hospital cardiac arrest at Stony Brook University Hospital and meet the study's airway and height requirements.

Not a fit: Patients who are already intubated, have valid do-not-attempt-resuscitation orders or opt-out bracelets, have traumatic causes of arrest (including drowning or electrocution), obvious signs of irreversible death, active gag reflex, significant airway obstruction, or specific esophageal or facial/neck conditions are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the device could provide a fast alternative airway to deliver short-term ventilation during CPR when endotracheal intubation is not feasible, potentially improving oxygenation and resuscitation outcomes.

How similar studies have performed: While supraglottic airway devices and other alternative airway techniques have been used during CPR with mixed results, this specific Ventor system is novel and is undergoing initial safety and effectiveness testing.

Eligibility criteria

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 this trial is running

Stony Brook, New York

• 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

Conditions Cardiac Arrest