The VENTOR Clinical Study

Not Applicable

Not yet recruiting

• Conditions: Cardiac Arrest (CA)

• Registration Number: NCT06759389
• Lead Sponsor: CoLabs Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-27
• Status Verified: 2025-01
• Study Start: 2025-01
• Study First Posted: 2025-01-06
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States