Ventor Airway System for Cardiac Arrest

(VENTOR Trial)

Overseen By Clay Nolan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CoLabs Medical

Must not be taking: Oxaliplatin, Leucovorin, Fluorouracil

Disqualifiers: Intubated, DNAR, Irreversible death, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 hour

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Ventor Airway System to determine if it can safely assist breathing during CPR when individuals cannot breathe independently. The goal is to evaluate the device's effectiveness in real-life emergencies, such as cardiac arrests. Ideal participants are adults who experience a non-traumatic cardiac arrest in a hospital setting and are at least 4 feet tall. As an unphased trial, participants contribute to groundbreaking research that could enhance emergency care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking Oxaliplatin, Leucovorin, or Fluorouracil, you will be excluded from participating.

What prior data suggests that the Ventor Airway System is safe for use during CPR?

Research shows that detailed safety information about the Ventor Airway System is not yet available. This means its safety for people remains largely unknown. The trial is in the "Not Applicable" phase, which typically assesses the safety and effectiveness of a new device. Researchers are still determining how well people can tolerate the Ventor Airway System.

Without specific safety data for this device, participants should understand that this trial is an early step in assessing its safety. Considering the potential risks and benefits is important, and discussing any concerns with the trial team is advised. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Ventor Airway System is unique because it offers a novel approach to managing cardiac arrest. Unlike traditional methods like manual ventilation or intubation, the Ventor device is designed to optimize airway management quickly and efficiently, potentially improving oxygen delivery during resuscitation. Researchers are excited about this treatment because it could enhance survival rates by providing a faster, more reliable airway solution during critical moments, which is crucial when every second counts.

What evidence suggests that the Ventor Airway System is effective for cardiac arrest?

Research has shown that managing the airway is crucial during cardiac arrest, as it maintains oxygen flow and removes carbon dioxide. The Ventor Airway System, which trial participants will receive, is designed to provide short-term breathing support for individuals who are not breathing. Early results suggest it effectively manages airways in these situations. Although specific data on Ventor's performance in humans is limited, providing ventilation during cardiac arrest has proven helpful. The system aims to improve resuscitation chances by ensuring air moves in and out of the lungs during CPR. ^{1 2 3 4 6}

Who Is on the Research Team?

Jignesh Patel, M.D., M.Sc.

Principal Investigator

Stony Brook University Hospital

Are You a Good Fit for This Trial?

The VENTOR Clinical Study is for adults aged 18-75 who are at least 4 feet tall and have experienced a non-traumatic in-hospital cardiac arrest. It's not for those with airway obstructions, esophageal diseases, severe facial injuries, small dental gaps, caustic substance ingestion, or incomplete medical records. Pregnant women, prisoners, terminally ill individuals or those with dementia are also excluded.

Inclusion Criteria

I am at least 4 feet tall.

I had a cardiac arrest not caused by injury.

Exclusion Criteria

I have a foreign object or growth in my upper airway.

I have a history of esophageal disease or serious neck injury.

Ingested caustic substances

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the Ventor Airway System during cardiopulmonary resuscitation (CPR) for short-term ventilation support

1 hour

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monitoring for device-related adverse events

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Ventor Airway System

Trial Overview This study tests the Ventor Airway System to see if it helps people breathe during CPR after they've stopped breathing due to cardiac arrest. The system aims to provide short-term ventilation support and its safety and effectiveness will be evaluated.

How Is the Trial Designed?

Group I: Ventor Experimental Treatment 1 Intervention

Subjects being treated with Ventor device

Who Is Running the Clinical Trial?

CoLabs Medical

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

Recent evidence suggests that advanced airway management techniques, like tracheal intubation, may be associated with worse neurological outcomes during the first 15 minutes of cardiac arrest, compared to not intubating during that critical period.

A large randomized clinical trial involving 2043 patients found no significant difference in favorable neurological outcomes between tracheal intubation and bag-mask ventilation when intubation was delayed until after return of spontaneous circulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To intubate or not to intubate? Gough, CJR., Nolan, JP.[2019]

A systematic analysis of adverse events in home mechanical ventilation (HMV) identified key risk factors such as patient transportation, suction, and tracheostomy decannulation, which can jeopardize patient safety.

The study suggests implementing risk mitigation measures, including checklists and reminder functions for caregivers, to enhance safety and prevent errors associated with HMV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Causes of adverse events in home mechanical ventilation: a nursing perspective. Lipprandt, M., Liedtke, W., Langanke, M., et al.[2022]

A review of 7827 safety reports from 2015 to 2020 revealed that only 67 (0.85%) were related to perioperative airway management, indicating that while these incidents are relatively rare, they can still pose significant risks to patients.

The most common adverse event was 'Intubation Injury,' accounting for 35.8% of airway management incidents, with the majority of events causing temporary or minor harm, highlighting the need for improved training and resources to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Airway management in the operating room setting: An analysis of reported safety events. Osgood, KB., Krishnan, S., Wheeler, KK., et al.[2022]

An interactive voice response system (IVRS) successfully identified 21% of elderly patients post-discharge who required follow-up, indicating its potential utility in monitoring patient safety after hospital discharge.

Despite the IVRS being well-received by patients (97% found it easy to use), it only detected 9% of actual adverse events (AEs), suggesting that additional monitoring strategies are needed to effectively capture more AEs and improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying patients with post-discharge care problems using an interactive voice response system. Forster, AJ., Boyle, L., Shojania, KG., et al.[2021]

In a South African pediatric intensive care unit (PICU), a retrospective audit identified a high rate of adverse events (50.8 per 100 patient days) among 80 patients, with catheter complications and hypoglycemia being the most common issues.

The study found that real-time registration during ward rounds reported a lower rate of adverse events (27.2 per 100 patient days) among 236 patients, highlighting that different registration methods can yield varying insights into patient safety and types of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in South Africa: PICU adverse event registration*. Vermeulen, JM., van Dijk, M., van der Starre, C., et al.[2014]

A new patient-centered taxonomy for categorizing adverse events (AEs) and near misses in emergency departments (EDs) was developed, focusing on specific harms like hypoxia and hemorrhage rather than general errors.

Testing of this taxonomy showed high inter-rater reliability, with 92% agreement at the category level, indicating it can effectively enhance quality and safety assessments in EDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical Review, Development, and Testing of a Taxonomy for Adverse Events and Near Misses in the Emergency Department. Griffey, RT., Schneider, RM., Todorov, AA., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06759389

Study Details | NCT06759389 | The VENTOR Clinical Study Study Overview. Brief Summary. To evaluate the initial safety and effectiveness of the Ventor Airway System in providing short-term ventilation support in ...

2. withpower.com withpower.com/trial/ventor-airway-system-for-cardiac-arrest-a0cbb

Ventor Airway System for Cardiac Arrest What data supports the effectiveness of the Ventor Airway System treatment for cardiac arrest? The research suggests that effective airway management is ...

3. trial.medpath.com trial.medpath.com/clinical-trial/838af042c52fe0c3/nct06759389-ventor-study-ventilation-airway-cardiac-arrest

The VENTOR Clinical Study | MedPath To evaluate the initial safety and effectiveness of the Ventor Airway System in providing short-term ventilation support in non-breathing subjects during ...

4. clinconnect.io clinconnect.io/trials/NCT06759389

The VENTOR Clinical Study (NCT06759389 ... - ClinConnect To evaluate the initial safety and effectiveness of the Ventor Airway System in providing short-term ventilation support in non-breathing subjects during ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7493547/

A review of ventilation in adult out‐of‐hospital cardiac arrest Ventilation may play a crucial role in cardiac arrest resuscitation by allowing for adequate oxygen administration and meaningful carbon dioxide elimination.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf11/p110024b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The ResQCPR System is intended for use as a CPR adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac ...