Ventilators, Mechanical Clinical Trial
Official title:
Transpulmonary Pressure During Volume Controlled Mechanical Ventilation Versus Airway Pressure Release Ventilation for Hypoxic Respiratory Failure - a Randomized Feasibility Study
The study examines individuals admitted to the intensive care unit due to breathing difficulties resulting in not getting enough oxygen into their bodies. These patient will receive mechanical ventilation and this study aims to determine how the pressure inside the lungs changes when using two different modes of mechanical ventilation. The goal is to improve management and care of breathing difficulties by gaining insight into changes in lung pressure during mechanical ventilation, as well as comparing the effectiveness of the two ventilator modes.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 1, 2026 |
Est. primary completion date | November 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Admitted to the ICU - Invasive mechanical ventilation with FiO2 = 50% OR PaO2-to-FiO2 ratio <20 kPa, including PEEP 3 5 cmH20 for at least 6 hours Exclusion Criteria: - Meeting inclusion criteria for more than 24 hours - Severe bronchospasm, defined as warranting treatment aimed at reversing this i.e. inhalation of anticholinergic or bronchodilator beyond what the patient normally use - Emphysema where treating physician judges the patient at increased risk for pneumothorax from APRV - Restrictive lung disease defined as a pre-admission diagnosis of restrictive lung disease - Undrained pneumothorax - Hemodynamic instability defined as more than 0.20 microgram/kg/min of norepinephrine or any dose of adrenaline infusion to maintain MAP = 65 mmHg - Age < 18 years - Patients who have received APRV previously during the current ICU admission - Patients in prone position within the last 24 hours |
Country | Name | City | State |
---|---|---|---|
Denmark | Hvidovre Hospital | Hvidovre | |
Denmark | Bispebjerg Hospital | København |
Lead Sponsor | Collaborator |
---|---|
University Hospital Bispebjerg and Frederiksberg |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Proportion of patients unable to tolerate observation period without increasing ventilator settings | Defined as measures aimed at increasing either oxygenation or ventilation | During observation period; 1-6 hours after randomization | |
Primary | Median peak transpulmonary pressure | Measured with esophageal manometry in cmH20. | During the observation period; 1-6 hours after randomization | |
Secondary | Proportion of patients with peak transpulmonary pressure > 12 cmH2O | Measured with esophageal manometry | During observation period; 1-6 hours after randomization | |
Secondary | Change in peak transpulmonary pressure in cmH20 | Measured with esophageal manometry. Calculated as beginning - end of observation period | During observation period; 1-6 hours after randomization | |
Secondary | Fluctuations in transpulmonary pressure in cmH20 | Measured with esophageal manometry. Difference between peak and nadir transpulmonary pressure during respiratory cycle | During observation period; 1-6 hours after randomization | |
Secondary | Change in fluctuations of transpulmonary pressure in cmH20 | Measured with esophageal manometry. Calculated as beginning - end of observation period. | During observation period; 1-6 hours after randomization | |
Secondary | Nadir PaO2-to-FiO2 ratio | Calculated by PaO2/FiO2. PaO2 from arterial blood gasses and FiO2 from ventilator setting | During observation period; 1-6 hours after randomization | |
Secondary | Peak FiO2 in % | FiO2 from ventilator settings | During observation period; 1-6 hours after randomization | |
Secondary | Peak PaCO2 in kPa | PaCO2 from arterial blood gasses | During observation period; 1-6 hours after randomization | |
Secondary | Nadir pH | pH from arterial blood gasses | During observation period; 1-6 hours after randomization | |
Secondary | Lung ultrasound aeration according to LUS | Evaluating lung aeration by Lung Ultrasound Score | During observation period; 1-6 hours after randomization |
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