The VENTOR Clinical Study (VENTOR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest (CA)
• Intervention / Treatment: Device: Resuscitation (Ventor)

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clay Nolan; Phone Number: (800) 592-6241; Email: clayn@colabsmedical.com

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Hospital
      • Contact: Jacqueline Skarre; Phone Number: 631-444-9033; Email: jacqueline.skarre@stonybrookmedicine.edu
      • Principal Investigator: Jignesh Patel, M.D., M.Sc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ventor; Subjects being treated with Ventor device	Device: Resuscitation (Ventor); Resuscitation with the Ventor device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to provide oxygenation during CPR	As measured through the monitoring of intra-arrest PaO2	From device insertion through 1 hour.
Ability to provide ventilation during CPR	As measured through the monitoring of intra-arrest PaCO2	From device insertion through 1 hour
Ability to provide oxygenation during CPR	As measured through the monitoring of intra-arrest cerebral oximetry	From device insertion through 1 hour
Number of participants with device-related adverse events	Number and rate of adverse events	From device insertion through 3 months

Collaborators and Investigators

• Sponsor: CoLabs Medical
• Investigators: Principal Investigator: Jignesh Patel, M.D., M.Sc., Stony Brook University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 27, 2024
• First Posted (Actual): January 6, 2025

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest
• Other Study ID Numbers: CIP 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No