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?

Mechanical ventilation can lead to diaphragm and lung injury. During mechanical ventilation, the diaphragm could be completely rested or it could be overworked, either of which may cause diaphragm injury. Mechanical stress and strain applied by mechanical ventilation or by the patient's own respiratory muscles can also cause injury to the lungs. Diaphragm and lung injury are associated with increased morbidity and mortality. Throughflow is a novel system that can reduce dead space without the need to increase the tidal ventilation, reducing the ventilatory demands and respiratory drive.

Will I have to stop taking my current medications?

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

How is the Through-flow System treatment different from other treatments for respiratory insufficiency?

The Through-flow System treatment is unique because it focuses on optimizing the flow of air and gases in the lungs, providing a more detailed analysis of ventilation and gas exchange compared to traditional methods. This approach can offer deeper insights into lung function and help tailor treatments more precisely for patients with respiratory insufficiency. ^{1 2 3 4 5}

What data supports the effectiveness of the Through-flow System treatment for respiratory insufficiency?

The research on computer-based evaluation systems and transtracheal oxygen administration suggests that tailored and optimized respiratory therapies can improve patient outcomes by ensuring precise oxygen delivery and reducing respiratory effort. These findings imply that the Through-flow System, which likely involves similar optimization and delivery techniques, could be effective in managing respiratory insufficiency. ^{3 6 7 8 9}

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

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

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

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

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]

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]

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]

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]

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]

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]

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 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]

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]

Citations

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

Computer-controlled optimization of positive end-expiratory pressure. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

[Long-term oxygen therapy (LTOT)--what should physicians, homecare-providers and health insurance companies know?]. [2014]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Computer-based evaluation of cardiopulmonary function for the optimization of ventilatory therapy in the adult respiratory distress syndrome. [2020]

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

Respiratory rehabilitation with transtracheal oxygen system. [2017]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Reliable detection of inspiration and expiration by computer. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

PDPS: a pulmonary data processing system for assessment of gas exchange properties by multiple gas wash-out. [2019]

7. Ireland pubmed.ncbi.nlm.nih.gov

System to obtain exercise respiratory flow waveforms. [2019]

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

Device for humidification and controlled oxygenation during spontaneous breathing. [2019]

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

Cardiac output determination: thermodilution versus a new computerized Fick method. [2013]