Actively Recruiting
Feasibility of Reducing Respiratory Drive in Patients with Acute Hypoxemic Respiratory Failure Using the Throughflow System
Led by University Health Network, Toronto · Updated on 2024-12-11
15
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
U
Unity Health Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of the Throughflow system in patients with acute hypoxemic respiratory failure who require invasive mechanical ventilation. The study focuses on reducing diaphragm and lung injury caused by mechanical ventilation, which can result from either disuse or excessive muscle loading. The Throughflow system aims to decrease anatomical dead space, thereby lowering ventilatory demands and respiratory drive, which may help protect the diaphragm and lungs during breathing support. The intervention involves using the Throughflow device that delivers a constant flow of fresh gas free of CO2 during inspiration. This device reduces the CO2 that remains in the upper airway after exhalation without increasing the tidal volume. During the ventilation titration phase, Throughflow settings will be adjusted in steps, starting from 0 LPM up to a maximum flow, with measurements taken every 10 minutes to determine optimal settings. Adjustments to the NAVA flow will be made accordingly to maintain total flow. Participants will be closely monitored through esophageal pressure swings, dynamic driving transpulmonary pressure, and oxygenation levels over 24 hours. Serious adverse events will also be tracked during this period. The study involves patients who are invasively ventilated with specific criteria for respiratory failure and lung imaging findings. The total involvement includes measurement collections during the Throughflow titration phase to assess respiratory effort and lung pressures under different settings.
CONDITIONS
Brief Title
Feasibility of Reducing Respiratory Drive Using the Through-flow System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- PaO2/FiO2 less than or equal to 300 at time of screening
- Oral endotracheal intubation with endotracheal tube size 7.5 or 8.0
- Receiving invasive mechanical ventilation
- Bilateral airspace opacities visible on chest radiograph or chest CT scan
You will not qualify if you...
- Contraindication to esophageal catheterization such as upper gastrointestinal tract surgery within the past 6 weeks or bleeding esophageal/gastric varices
- Intubation due to traumatic brain injury or stroke
- Intracranial hypertension (suspected or diagnosed)
- Expected to be taken off mechanical ventilation within 24 hours
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours
Participants receive ventilation using the Throughflow system, which reduces anatomical dead space by providing a constant flow of fresh gas during inspiration. Ventilation settings are adjusted in steps to reduce respiratory drive, with measurements collected every 10 minutes during titration phases.
Continuous monitoring during ventilator use with measurements every 10 minutes during titration phases
Trial Site Locations
Total: 1 location
1
University Health Network
Toronto, Ontario, Canada, M5G 2N2
Actively Recruiting
Research Team
R
Rongyu ( Cindy) Jin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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