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Trials / Completed

CompletedNCT06224010

Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS

Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS: a Multicentric Prospective Observational Study

Status
Completed
Phase
—
Study type
Observational
Enrollment
56 (actual)
Sponsor
University of Turin, Italy · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Data comparing respiratory drive and effort in critically ill patients with acute respiratory distress syndrome associated to different severity of COVID-19 penumonia (CARDS) and to other risk factors are lacking. Objectives: To assess respiratory drive and effort of CARDS patients at the first transition from controlled to assisted spontaneous breathing. The second aim was the rate of a composite outcome including the need of higher level of sedation

Detailed description

Multicenter cohort study in four Italian ICU including adults with moderate and severe CARDS (PaO2/FiO2 \<100 mmHg) at ICU admission. An historical cohort of patients with ARDS from various etiologies used for comparison. Respiratory drive (P0.1), diaphragm electrical activity (EAdi), inspiratory effort derived from EAdi (∆PmusEAdi) and from deflection in airway pressure occluded (ΔPocc) (PmusΔPocc), dynamic transpulmonary driving pressure (ΔPL,dyn, the difference between peak and end-expiratory transpulmonary pressure) measured under assisted ventilation. The main ventilatory pattern variables: * Airway Occlusion Pressure (P0.1): Measurement of the decrease in airway pressure during an end-expiratory occlusion. * Pmus-EAdi-derived (∆Pmus, EAdi): Measurement of the pressure generated by the respiratory muscles during inspiration derived by electrical activity of the diaphragm measurements. * Transpulmonary pressure EAdi-derived (∆Plung,dyn): difference between peak and end-expiratory transpulmonary pressure . * Occlusive Pressure Difference (∆Pocc): Evaluation of the pressure difference between the initial and final airway opening during inspiration. * Pmus-∆Pocc-derived (∆Pmus, ∆Pocc): Measurement of the pressure generated by the respiratory muscles during inspiration derived by ∆Pocc (∆Pocc\*0.75) * Transpulmonary driving pressure ∆Pocc derived (∆Plung, ∆Pocc): calculated as (Peak airway pressure -PEEP) - 2/3 \* ∆Pocc * Diaphragmatic Electrical Activity (EAdi): Recording of the electrical activity of the diaphragm. * Peak EAdi (EAdiPEAK): Determination of the highest recorded value of diaphragmatic electrical activity. * Pressure time product of the trans-diaphragmatic pressure per breath and per minute(PTP/min): the integral of Pmusc-EAdi-derived during inspiration per breath. * Inspiratory Delay (ID): Assessment of the time delay between the start of neural inspiration and the onset of mechanical ventilation. * Neuro-ventilatory Efficiency (NVE): Measurement of the efficiency of the neural drive to the respiratory muscles. * Peak Airway Opening Pressure (PawPEAK): Measurement of the peak pressure in the airway during inspiration. * Inspiratory Pressure-Time Product (PmusEAdi/b): Calculation of the work of breathing by integrating the product of diaphragmatic electrical activity and the change in airway pressure during inspiration. * Tidal Volume (VT): Measurement of the volume of air inspired and expired during each breath. * Respiratory Rate: Calculation of the number of breaths per minute delivered by the mechanical ventilator. * Inspiratory and Expiratory Time (Ti,MECH and Te,MECH): Determination of the duration of mechanical inspiration and expiration. * Inspiratory Duty Cycle (TI/TTOT-neur): Calculation of the ratio of inspiratory time to total respiratory cycle time based on neural inspiration.

Conditions

Interventions

TypeNameDescription
OTHERRespiratory drive and effort assessmentThe use of a neurally-adjusted ventilatory assist catheter, the measurement of electrical activity of the diaphragm, ∆Pocc, P0.1, and other ventilatory parameters to assess respiratory drive and effort in three cohorts of patients

Timeline

Start date
2020-11-21
Primary completion
2023-06-01
Completion
2023-06-20
First posted
2024-01-25
Last updated
2024-01-25

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT06224010. Inclusion in this directory is not an endorsement.