Recruiting

Ventor Airway System

Sponsor:

CoLabs Medical

Code:

NCT06759389

Conditions

Cardiac Arrest (CA)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Resuscitation (Ventor)

Study Details

Brief 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.

Conditions

Cardiac Arrest (CA)

Study ID

NCT06759389

Start date

Apr 4, 2025

Status verified date

Apr, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ventor

Subjects being treated with Ventor device

Interventions

Resuscitation (Ventor)

Resuscitation with the Ventor device

Primary outcome measure

  • Ability to provide oxygenation during CPR [ Time Frame: From device insertion through 1 hour. ]
  • Ability to provide ventilation during CPR [ Time Frame: From device insertion through 1 hour ]
  • Ability to provide oxygenation during CPR [ Time Frame: From device insertion through 1 hour ]
  • Number of participants with device-related adverse events [ Time Frame: From device insertion through 3 months ]

Central Contacts and Locations

Central contacts

Locations

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Principal Investigator:

Jignesh Patel, M.D., M.Sc.

More Information

Sponsor

CoLabs Medical

Last update posted

Jun 11, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CoLabs Medical on 2025-06-11.