Respiratory Insufficiency Clinical Trial
— ThroughflowOfficial title:
Feasibility of Reducing Respiratory Drive in Patients With Acute Hypoxemic Respiratory Failure Using the Through-flow System
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 31, 2024 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - PaO2/FiO2 less than or equal to 300 at time of screening - Oral endotracheal intubation and mechanical ventilation - Bilateral airspace opacities on chest radiograph or chest CT scan Exclusion Criteria: - Contraindication to esophageal catheterization (upper gastrointestinal tract surgery within preceding 6 weeks, bleeding esophageal/gastric varices) - Intubation for traumatic brain injury or stroke - Intracranial hypertension (suspected or diagnosed by medical team) - Anticipated liberation from mechanical ventilation within 24 hours |
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Unity Health Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Esophageal pressure swing (respiratory effort) | Changes in esophageal pressure swing from baseline to protocol completion will be described using central tendency and dispersion measurements (median and 25%-75% interquartile range) for each variable at each time point of the protocol | 24 hours | |
Primary | Dynamic driving transpulmonary pressure (lung-distending pressure) | Changes in the dynamic driving transpulmonary pressure from baseline to protocol completion will be described using central tendency and dispersion measurements (median and 25%-75% interquartile range) for each variable at each time point of the protocol | 24 hours | |
Primary | Oxygenation (PaO2/FiO2 ratio) | Changes in PaO2/FiO2 from baseline to protocol completion will be described using central tendency and dispersion measurements (median and 25%-75% interquartile range) for each variable at each time point of the protocol | 24 hours | |
Secondary | Changes in dose of sedative medications achieved during the titration phase | Changes in sedation achieved during the sedation titration phase and whether maintaining TF can facilitate reductions in sedation based on the effect of withdrawing Throughflow will be assessed | 24 hours | |
Secondary | Rate of serious adverse events | The number of SAEs during the protocol will be measured and quantified. | 24 hours |
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