Hope inVent for Artificial Respiration

AJ
TS
Overseen ByTracy S Williams, R.N.
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: National Institutes of Health Clinical Center (CC)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new miniature breathing device called Hope inVent. Designed for short-term breathing support when regular ventilators are unavailable, such as during emergencies or disasters, the trial involves brain-dead organ donors already on mechanical ventilation. Researchers aim to determine if the device can maintain proper oxygen and carbon dioxide levels for a short period. Suitable candidates are brain-dead individuals cleared for organ donation, excluding those with severe lung issues or potential lung donors. The goal is to assess if this device could serve as a low-cost solution for future emergency breathing support. As an unphased trial, it offers a unique opportunity to contribute to innovative solutions for emergency medical care.

Will I have to stop taking my current medications?

The trial does not specify whether participants must stop taking their current medications. However, since the study involves brain-dead organ donors, medication use is not applicable in the traditional sense.

What prior data suggests that the Hope inVent device is safe for use in emergencies?

Research shows that the Hope inVent device, a new small breathing device, is being tested for safety and effectiveness in emergency breathing support. This marks its first use in humans, so no previous data exists on human tolerance. However, the device prioritizes safety. It connects to a breathing tube and uses compressed oxygen to assist breathing, without any moving parts, potentially reducing the risk of malfunction.

At this early testing stage, researchers are still gathering data on the device's safety for people. Since it hasn't been tested in humans outside of this trial, determining its exact safety level is challenging. Before any new treatment advances to larger trials, researchers closely monitor it for side effects or safety issues.

In this study, the Hope inVent will be used temporarily on brain-dead organ donors already on mechanical ventilation. If any safety concerns arise, they will immediately switch back to the standard ventilator. This careful monitoring ensures that any potential issues are quickly addressed.12345

Why are researchers excited about this trial?

Researchers are excited about the Hope inVent miniature in-line respirator because it offers a unique approach to artificial respiration for brain-dead organ donors. Unlike standard mechanical ventilators, which are generally larger and less flexible, the Hope inVent device is designed to be compact and pressure-cycled, allowing for potentially more precise and efficient respiratory support. This could lead to better physiological stability during organ preservation, which is crucial for successful organ transplantation. By providing a new delivery method, the Hope inVent respirator could enhance the current standard of care in organ donation scenarios.

What evidence suggests that the Hope inVent device is effective for providing short-term breathing support?

Studies have shown that mechanical ventilation plays a crucial role in emergencies requiring breathing support. This trial will test the Hope inVent device, a miniature in-line respirator, for its ability to provide simple and effective breathing assistance by using compressed oxygen to move air in and out of the lungs. Although detailed clinical data on this specific device remains limited, its design lacks moving parts, potentially making it a reliable option for short-term use when regular ventilators are unavailable. Research on similar ventilation methods has demonstrated better patient outcomes and more efficient breathing support. These early indications suggest that the Hope inVent could serve as a useful alternative in critical situations.678910

Who Is on the Research Team?

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Andrew J Mannes, M.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Are You a Good Fit for This Trial?

This trial is for brain-dead organ donors already on a ventilator at the Gift of Life Donor Care Center, with permission for both organ donation and research. Donors who may donate lungs or have major lung disease are not included.

Inclusion Criteria

I am eligible regardless of my age or gender.
Provision of signed and dated informed consent form for organ donation and research by donor family or surrogate decisionmaker
I have been diagnosed with brain death.
See 1 more

Exclusion Criteria

My body weight is less than 25 kg as a brain-dead research donor.
Potential brain-dead lung transplant donors as determined by Gift of Life Donor Program staff at study site admission
Intraoperative arterial blood gas values outside normal range for pH (7.35-7.45), PaO2 (>=75 mm Hg), PaCO2 (35-45 mm Hg), HCO3 (22-26 mEq/L), or SpO2 (94-100%) while on optimized ventilation
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

The Hope inVent device is used to ventilate brain-dead organ donors for up to 15 minutes, with continuous monitoring of respiratory measures.

15 minutes
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 days

What Are the Treatments Tested in This Trial?

Interventions

  • Hope inVent

Trial Overview

Researchers are testing Hope inVent, a small single-use breathing device that connects to a breathing tube and uses compressed oxygen to help move air in and out of the lungs. The device will be used briefly (up to 15 minutes) instead of the standard ventilator.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Hope inVent Miniature In-line RespiratorExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institutes of Health Clinical Center (CC)

Lead Sponsor

Trials
391
Recruited
30,880,000+

Citations

Prediction of Spontaneous Breathing Trial Outcome in ...

This study aims to develop an artificial intelligence–based prediction model to predict whether a patient can successfully pass a spontaneous ...

The mechanical ventilator of the future: a breath ... - PMC - NIH

This article provides an overview on the subject, from the emergent nations perspective. Keywords: Artificial intelligence, machine learning, mechanical ...

Using Artificial Intelligence to Predict Mechanical ...

This model, based on data reflecting the state of the patient 2 h before a planned extubation, showed excellent predictive capabilities, with an AUROC of 98.3%.

a breath of hope for the viral pandemics to come

Mechanical Ventilation is a comprehensive guide to the evaluation and management of critically ill patients requiring mechanical ventilatory ...

Spontaneous vs Controlled Mechanical Ventilation in ...

Observational studies suggest that allowing spontaneous effort may reduce need for sedation and increase ventilator-free days. spontaneous breathing in severe ...

Study Details | NCT07768215 | Miniature In-line Respirator

This first-in-human pilot study will test an investigational miniature breathing device called the Hope inVent. The device is a small, ...

fluidIQ's HOPE inVent™ Miniature In-Line Resuscitator ...

“We believe our miniature resuscitator has the potential to change how rescue breathing is delivered in challenging real-world environments.” Authors of the ...

In-line miniature 3D-printed pressure-cycled ventilator - PMC

Associated Data. This section collects any data citations, data availability statements, or supplementary materials included in this article.

1910.504 - Mini Respiratory Protection Program.

Do not wear your respirator where other workplace hazards (e.g., chemical exposures) require use of a respirator. In such cases, your employer must provide you ...

fluidIQ's HOPE inVent™ Miniature In-Line Resuscitator ...

“We believe our miniature resuscitator has the potential to change how rescue breathing is delivered in challenging real-world environments.” Authors of the ...