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NCT Number: NCT06759389

The VENTOR Clinical Study

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location status: Recruiting

Location contact

Jacqueline Skarre

CONTACT

[email protected]

631-444-9033

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

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Resuscitation (Ventor)

Device

Resuscitation with the Ventor device

Primary outcomes

  1. Ability to provide oxygenation during CPR

    Time frame: From device insertion through 1 hour.

    As measured through the monitoring of intra-arrest PaO2

  2. Ability to provide ventilation during CPR

    Time frame: From device insertion through 1 hour

    As measured through the monitoring of intra-arrest PaCO2

  3. Ability to provide oxygenation during CPR

    Time frame: From device insertion through 1 hour

    As measured through the monitoring of intra-arrest cerebral oximetry

  4. Number of participants with device-related adverse events

    Time frame: From device insertion through 3 months

    Number and rate of adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Clay Nolan

CONTACT

[email protected]

(800) 592-6241

Sponsors and collaborators

Lead sponsor

CoLabs Medical

Industry

Registry information

Official study title

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

Acronym: VENTOR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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