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.
As hypoxic respiratory failure is an acute condition, this trial will enrol temporarily incompetent patients and obtain consent from the patient's next of kin and an independent medical doctor (trial guardian) as soon as possible after enrolment. When included in the study, patients will be randomized 1:1 centrally in the RedCap system, using a computer-generated concealed assignment sequence, with permuted blocks of varying sizes, to start with either the intervention (APRV) followed by control (volume controlled mechanical ventilation) or control followed by intervention. Esophageal manometry will be used as a surrogate to measure the transpulmonary pressure. Arterial blood gasses, blood samples and lung ultrasound will be used to investigate oxygenation, ventilation and aeration. Treatment targets for both groups during the study are pH \>7.20, saturation ≥ 88% and PaO2 ≥ 8.0 kPa, with FiO2 titrated as low as possible while complying to the oxygenation targets (PaO2 and saturation). Both arms start with an 'adjustment phase' where the ventilator is adjusted so the respiratory values are within the targets. The intervention adjustment phase is at least 30 minutes. The adjustments will follow standardized protocols. When the respiratory values are within range, the 'observation period begins' and no changes are made to the ventilator for 3 hours, unless it is necessary to achieve ventilatory treatment targets or deemed necessary by the treating physician. During the trial, the patient must be positioned in a supine position with the headboard elevated 0-30 degrees. After the first 'observation period', the patient is switched to the opposite ventilation mode and will go through an 'adjustment phase' and 'observation period' again. Once a patient regains competence, they will be provided with both written and oral information regarding the trial By comparing volume controlled mechanical ventilation and APRV and their transpulmonary pressures, valuable insight can be gained regarding optimal ventilation strategy for patients with hypoxic respiratory failure. Understanding how various ventilation modes influence transpulmonary pressure and their potential effects on respiratory mechanics can potentially inform designs of trials with individualized respiratory care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
45
Mechanical ventilation mode
Mechanical ventilation mode
Bispebjerg Hospital
Copenhagen, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Median peak transpulmonary pressure
Measured with esophageal manometry in cmH20.
Time frame: During the observation period; 1-6 hours after randomization
Proportion of patients with peak transpulmonary pressure > 12 cmH2O
Measured with esophageal manometry
Time frame: During observation period; 1-6 hours after randomization
Change in peak transpulmonary pressure in cmH20
Measured with esophageal manometry. Calculated as beginning - end of observation period
Time frame: During observation period; 1-6 hours after randomization
Fluctuations in transpulmonary pressure in cmH20
Measured with esophageal manometry. Difference between peak and nadir transpulmonary pressure during respiratory cycle
Time frame: During observation period; 1-6 hours after randomization
Change in fluctuations of transpulmonary pressure in cmH20
Measured with esophageal manometry. Calculated as beginning - end of observation period.
Time frame: During observation period; 1-6 hours after randomization
Nadir PaO2-to-FiO2 ratio
Calculated by PaO2/FiO2. PaO2 from arterial blood gasses and FiO2 from ventilator setting
Time frame: During observation period; 1-6 hours after randomization
Peak FiO2 in %
FiO2 from ventilator settings
Time frame: During observation period; 1-6 hours after randomization
Peak PaCO2 in kPa
PaCO2 from arterial blood gasses
Time frame: During observation period; 1-6 hours after randomization
Nadir pH
pH from arterial blood gasses
Time frame: During observation period; 1-6 hours after randomization
Lung ultrasound aeration according to LUS
Evaluating lung aeration by Lung Ultrasound Score
Time frame: During observation period; 1-6 hours after randomization
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