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Recruiting NCT06759389

The VENTOR Clinical Study

No phase Interventional Cardiac Arrest (CA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Resuscitation (Ventor).
Who it may be relevant to
Registry conditions: Cardiac Arrest (CA). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Resuscitation (Ventor)
    Resuscitation with the Ventor device

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stony Brook University Hospital — Stony Brook

Identifiers

NCT: NCT06759389 · CIP 1.0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗