The VENTOR Clinical Study
VENTOR
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2024
CompletedFirst Posted
Study publicly available on registry
January 6, 2025
CompletedStudy Start
First participant enrolled
April 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
CompletedJune 11, 2025
April 1, 2025
1.2 years
December 19, 2024
June 7, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (1)
Ventor
EXPERIMENTALSubjects being treated with Ventor device
Interventions
Eligibility Criteria
You may qualify if:
- Adults aged 18-75 years, inclusive
- IHCA (non-traumatic)
- At least 4 feet in height
You may not qualify if:
- 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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CoLabs Medicallead
Study Sites (1)
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jignesh Patel, M.D., M.Sc.
Stony Brook University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2024
First Posted
January 6, 2025
Study Start
April 4, 2025
Primary Completion
June 1, 2026
Study Completion
June 1, 2026
Last Updated
June 11, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share