About The Ventor Study
What is the VENTOR Study?
Stony Brook University Hospital is conducting a research study on the emergency treatment of patients who have experienced cardiac arrest. This research study, called VENTOR, aims to evaluate the possible benefits of the Ventor Airway System. This new investigational device is designed to be an easy-to-insert airway and ventilation device that may improve the effectiveness of CPR by utilizing a new ventilation method which may enhance oxygen delivery to the patient. Cardiac arrest is a life-threatening condition where the heart suddenly stops beating, leading to a loss of blood flow to the brain and other vital organs. Survival rates and neurological outcomes are often poor due to inadequate oxygen circulation during resuscitation.
Who will be treated
Adults who experience cardiac arrest within Stony Brook University Hospital, without an airway tube already in place, are treated within the hospital's emergency care services.
Study Groups:
There are no control groups in this study. All participants will receive the Ventor Airway System during CPR to evaluate its effectiveness in improving outcomes. All participants will also receive standard medical care during the cardiac arrest and after, including close management of their condition and care within an intensive care unit, if necessary.
Benefits & Risks:
Risk: The Ventor Airway System may have risks similar to other airway devices, including possible airway obstruction or complications from device insertion. There may also be unknown risks associated with the new device.
Benefits: The purpose of the study is to determine the safety and effectiveness of the Ventor Airway System in improving oxygen delivery and patient outcomes during cardiac arrest. While it is not known whether or not participants will directly benefit, the knowledge gained from this study may help doctors learn more about what treatments are most effective for cardiac arrest.
How is VENTOR different from many other studies?
Because of the severity of cardiac arrest, patients eligible for the VENTOR study will almost always be unable to say whether or not they wish to participate. A special set of government rules allows studies to include patients with an “exception from informed consent” under these circumstances. This is only allowed in life-threatening situations where the best strategy is unknown, there is potential benefit to participants, and it may not be possible to get consent from the patients’ families or legal representatives before the study strategies need to begin. We are asking community members to think about this research and let us know what they think about the VENTOR study.
What if I don’t want to participate in VENTOR Study?
If you do not wish to be enrolled in the VENTOR research study, you must carry an “opt-out card” and/or "opt-out bracelet/necklace" at all times during the study enrollment period. Emergency teams and hospital staff will look for this card, bracelet, or necklace, and researchers will know not to enroll you in this study if they locate this information. If you would like to opt out, please click here to request an Opt-Out bracelet or print the Opt-Out Card. Alternatively you can contact the study team, click here. You may also want to inform your family of your wishes to NOT participate in this study.