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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Ventor Airway System treatment for cardiac arrest?

The research suggests that effective airway management is crucial during CPR for cardiac arrest, as it helps with reoxygenation. While the Ventor Airway System is not directly studied, similar airway management strategies have shown to improve outcomes in cardiac arrest patients. ^{1 2 3 4 5}

Is the Ventor Airway System generally safe for use in humans?

The research articles reviewed do not provide specific safety data for the Ventor Airway System. However, they highlight that airway management in medical settings can have risks, such as temporary or minor harm during procedures like intubation. This suggests that while airway management systems can be safe, they require careful handling and monitoring to minimize risks. ^{6 7 8 9 10}

How is the Ventor Airway System treatment different from other treatments for cardiac arrest?

The Ventor Airway System is unique because it uses a modified airway device to deliver continuous oxygen during cardiac arrest, which can provide effective oxygenation and ventilation without the complications associated with traditional methods like endotracheal intubation. This approach combines continuous oxygen flow with chest compressions, offering a potentially safer and effective alternative for managing cardiac arrest. ^{11 12 13 14 15}

Research Team

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

Principal Investigator

Stony Brook University Hospital

Eligibility Criteria

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 between 18 and 75 years old.

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.

Known vulnerable subject other than Inclusion #3, such as known (e.g.: prisoner, pregnancy, terminal illness, dementia)

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

To intubate or not to intubate? [2019]

2. Ireland pubmed.ncbi.nlm.nih.gov

Effect of airway management strategies during resuscitation from out-of-hospital cardiac arrest on clinical outcome: A registry-based analysis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The impact of oxygen and carbon dioxide management on outcome after cardiac arrest. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Quality of survival after cardiopulmonary resuscitation. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The experience of the nurse at triage influences the timing of CPAP intervention. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Identifying patients with post-discharge care problems using an interactive voice response system. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Patient safety in South Africa: PICU adverse event registration*. [2014]

8. England pubmed.ncbi.nlm.nih.gov

Causes of adverse events in home mechanical ventilation: a nursing perspective. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Airway management in the operating room setting: An analysis of reported safety events. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Critical Review, Development, and Testing of a Taxonomy for Adverse Events and Near Misses in the Emergency Department. [2020]

11. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of six different airway devices regarding regurgitation and pulmonary aspiration during cardio-pulmonary resuscitation (CPR) - A human cadaver pilot study. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Oxygenation and ventilation during cardiopulmonary resuscitation utilizing continuous oxygen delivery via a modified pharyngeal-tracheal lumened airway. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Intrabronchial Catheter Resuscitation for Respiratory and Cardiorespiratory Arrest. [2019]

14. China pubmed.ncbi.nlm.nih.gov

[The effects of different mechanical ventilation flow model on the peak airway pressure during cardiopulmonary resuscitation]. [2018]

15. Ireland pubmed.ncbi.nlm.nih.gov

Association between the presence of an advanced airway and ventilation rate during pediatric CPR: A report from the Videography in Pediatric Resuscitation (VIPER) collaborative. [2023]