Through-flow System for Respiratory Insufficiency

(Throughflow Trial)

Overseen By Rongyu ( Cindy) Jin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Brain injury, Stroke, Intracranial hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system called Throughflow, designed to help people on mechanical ventilation breathe more easily. The goal is to reduce diaphragm and lung injuries by clearing leftover carbon dioxide from the airways without stressing the lungs. This system may benefit those on a ventilator due to lung issues shown in chest scans and who struggle to get enough oxygen. It targets patients currently intubated with specific types of breathing tubes and diagnosed with certain lung conditions through tests. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance breathing support for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Throughflow System is safe for reducing dead space in patients with respiratory insufficiency?

Research has shown that the Throughflow system is designed to help patients on mechanical ventilation breathe more easily by removing carbon dioxide (CO2) that typically remains in the upper airway after exhaling. This process reduces strain on the lungs and the diaphragm, the muscle that aids in breathing.

Although specific safety data is limited, the system aims to lessen the workload on the lungs, potentially reducing injuries to the diaphragm and lungs, which are common risks with mechanical ventilation. As this trial is in an early phase, researchers continue to study safety. By reducing CO2 build-up, the Throughflow system could offer a safer way to protect the lungs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Throughflow system for respiratory insufficiency because it offers a new way to manage dead space in the lungs, which is an area where exhaled CO2 typically lingers. Unlike traditional mechanical ventilation strategies that might require increasing the volume of air delivered to the lungs, Throughflow provides a constant flow of fresh gas that effectively clears CO2 without increasing lung volume. This means it can help reduce the workload on the patient's respiratory system and potentially protect the lungs from damage, making it a safer option.

What evidence suggests that the Throughflow System is effective for respiratory insufficiency?

Research has shown that the Throughflow system, which participants in this trial will receive, can reduce areas in the lungs where air doesn't get exchanged, without increasing the volume of air inhaled and exhaled with each breath. This eases breathing for patients. By providing a steady flow of fresh air, it removes carbon dioxide that typically remains in the upper airway after exhalation. As a result, the lungs exert less effort, potentially protecting them from damage. Early findings suggest that this method is safe and beneficial for patients using mechanical ventilation. ^{1 2 6 7 8}

Who Is on the Research Team?

Lorenzo Del Sorbo

Principal Investigator

University Health Network, Toronto

Ewan Goligher, MD, PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for patients with a specific type of breathing difficulty due to lung or diaphragm injury, who are already on mechanical ventilation. They must have a certain level of oxygenation issues and visible lung problems on imaging tests. It's not for those with high brain pressure, expected to be off the ventilator within a day, recent upper GI surgery, or intubated due to brain injury or stroke.

Inclusion Criteria

Your blood oxygen level is too low at the time of screening.

I am on a breathing machine through a tube in my mouth.

You have cloudy areas in both lungs on a chest X-ray or CT scan.

Exclusion Criteria

I have been diagnosed with high pressure in my brain.

I haven't had upper GI surgery or issues with bleeding in my esophagus/stomach recently.

I was intubated due to a brain injury or stroke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the Throughflow system to reduce anatomical dead space during mechanical ventilation

24 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Throughflow titration phase

Trial Overview The study is testing the Throughflow system which aims to reduce respiratory drive without increasing breath size by removing dead space in mechanically ventilated patients. This could potentially prevent further damage to the lungs and diaphragm caused by overworking during artificial ventilation.

How Is the Trial Designed?

Group I: Throughflow Experimental Treatment 1 Intervention

Throughflow is a novel system that reduces anatomical dead space by providing a constant flow of fresh gas (i.e., gas that is free of CO2) during inspiration in patients receiving invasive mechanical ventilation. By clearing the CO2 that normally remains in the upper airway after exhalation (anatomical dead space), TF can dramatically reduce anatomical dead space without the need to increase the delivered VT, making it a safe strategy in terms of lung protection. This reduction in dead space reduces the ventilatory demands of the patients, reducing respiratory drive.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Published Research Related to This Trial

The computerized system for analyzing respiratory flow and gas exchange provides highly accurate measurements of oxygen consumption (VO2) and carbon dioxide production, showing a strong correlation (r = .92) with traditional thermodilution cardiac output methods.

This new computerized method is not only accurate but also offers greater reproducibility compared to traditional Douglas bag techniques, making it a promising tool for respiratory and cardiac assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac output determination: thermodilution versus a new computerized Fick method. Carpenter, JP., Nair, S., Staw, I.[2013]

The study presents a new humidification system designed for spontaneously breathing patients, allowing for adjustable flows and oxygen concentrations, which can enhance patient comfort and respiratory function.

This system aims to improve the delivery of humidified oxygen, potentially leading to better outcomes in patients requiring respiratory support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device for humidification and controlled oxygenation during spontaneous breathing. Talsma, P., Optroodt, N., Havill, JH.[2019]

A new computerized system for optimizing Positive End-Expiratory Pressure (PEEP) was developed and tested on six dogs with induced pulmonary injury, demonstrating the ability to reach optimal PEEP levels efficiently, particularly with the FRC normalization algorithm achieving this in just 40 minutes.

This automated noninvasive PEEP titration system can enhance patient care by ensuring that PEEP therapy is continuously optimized, potentially improving outcomes for patients with refractory hypoxemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-controlled optimization of positive end-expiratory pressure. East, TD., Andriano, KP., Pace, NL.[2020]

The described respiratory monitoring system effectively measures key respiratory parameters such as flow rate waveforms, tidal volume, and respiration rate using a microcomputer and analog-to-digital converter, making it a versatile tool for respiratory analysis.

This system is not only reliable but also cost-effective, allowing for automatic data acquisition at fixed intervals, which enhances its usability in various settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

System to obtain exercise respiratory flow waveforms. Johnson, AT., Dooly, CR.[2019]

The proposed computer-assisted method effectively distinguishes between inspiratory and expiratory phases of breathing by analyzing gas flow and CO2 concentration, making it particularly useful for critical care patients.

This algorithm remains reliable even in the presence of marked variations in tidal volume and mechanical artifacts, ensuring accurate bedside analysis during critical situations like weaning from ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliable detection of inspiration and expiration by computer. Brunner, J., Wolff, G., Langenstein, H., et al.[2019]

Long-term oxygen treatment (LTOT) significantly improves the prognosis for patients with chronic respiratory insufficiency by enhancing oxygenation, lowering pulmonary artery pressure, and reducing respiratory effort.

Individualized therapy is crucial for LTOT, as patients require tailored solutions that consider their mobility needs and the specific characteristics of different oxygen delivery systems, such as stationary versus mobile devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term oxygen therapy (LTOT)--what should physicians, homecare-providers and health insurance companies know?]. Koehler, U., Hildebrandt, O., Jerrentrup, L., et al.[2014]

The data acquisition and processing system effectively analyzes inert gas wash-out tests in both spontaneously breathing and mechanically ventilated patients, enhancing the understanding of ventilation inhomogeneity.

By measuring respiratory flow and gas fractions, the system provides valuable insights into lung function, including end-expiratory lung volume and the distribution of ventilation and perfusion, which are crucial for optimizing patient care in intensive care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PDPS: a pulmonary data processing system for assessment of gas exchange properties by multiple gas wash-out. Huygen, PE., Feenstra, BW., Hoorn, E., et al.[2019]

Transtracheal oxygen administration is more effective for rehabilitating COPD patients compared to traditional oxygen delivery methods, allowing for therapeutic oxygen levels with significantly lower flow rates (0.25 to 1 liter per minute).

This method requires 3 to 4 times less oxygen than nasal cannulas or Venturi masks, enabling patients to use a smaller, portable tank that lasts most of the day, while also improving their ability to breathe and engage in normal activities immediately after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory rehabilitation with transtracheal oxygen system. Heimlich, HJ.[2017]

A new computer-based evaluation system has been developed to assess respiratory dynamics and gas exchange in intubated patients, particularly those suffering from adult respiratory distress syndrome (ARDS) due to trauma or sepsis.

This system allows for real-time data analysis, enabling healthcare providers to tailor ventilatory therapies to individual patient needs, leading to more precise and effective treatment strategies for ARDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based evaluation of cardiopulmonary function for the optimization of ventilatory therapy in the adult respiratory distress syndrome. Siegel, JH., Stoklosa, J., Geisler, FH., et al.[2020]

Citations

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Feasibility of Reducing Respiratory Drive Using the ... Throughflow is a novel system that can reduce dead space without the need to increase the tidal ventilation, reducing the ventilatory demands and respiratory ...

2. withpower.com withpower.com/trial/phase-diaphragm-injury-11-2022-380dd

Through-flow System for Respiratory Insufficiency What data supports the effectiveness of the Through-flow System treatment for respiratory insufficiency? ... outcomes ... mechanical ventilation. 24 hours.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8993478/

Management of Respiratory Failure - PubMed Central - NIH This review aims to give an overview of the basic principles of invasive and noninvasive mechanical ventilation.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9854387/

Effectiveness of high-flow nasal cannula therapy on clinical ... In adult patients hospitalized with COVID-19, HFNC may prove effective in reducing the rate of orotracheal intubation.

5. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-022-04281-w

Effect of high-flow oxygen versus T-piece ventilation strategies ... Among patients receiving mechanical ventilation, high-flow oxygen SBT did not significantly reduce the risk of weaning failure compared with T-piece SBT.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05642832/feasibility-of-reducing-respiratory-drive-using-the-through-flow-system

Feasibility of Reducing Respiratory Drive Using the ... Diaphragm weakness is associated with prolonged duration of mechanical ventilation and higher risk of death. Clinical data and experimental ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK539742/

Mechanical Ventilation - StatPearls - NCBI Bookshelf Mechanical ventilation is a critical intervention to sustain life in acute or emergent settings, particularly in patients with compromised airways.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10156500/

Flow-controlled ventilation – a new and promising method of ... Flow-controlled ventilation is a new modality of mechanical ventilation based on a constant flow during both inspiration and expiration.