Clinical trial NCT05248243: Recruitment Assessment in Patients With Acute Respiratory Distress Syndrome and Covid-19
Official title: Recruitment Assessment in Patients With Acute Respiratory Distress Syndrome and Covid-19
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Distress Syndrome
COVID-19 Pneumonia
Recruitment
Lead sponsor: Ramos Mejía Hospital
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 41
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 15 years of age or older who have been receiving MV in the first 7 days and have been defined as ARDS and ARDS-Covid-19 (with a positive polymerase chain reaction in nasopharyngeal swab samples) according to the clinical criteria of the Berlin definition.

Brief summary: Respiratory failure associated with Covid-19 can be expressed as acute respiratory distress syndrome (ARDS), which is an acute inflammatory lung injury,which generally requires the use of invasive mechanical ventilation (MV). There are inconclusive results regarding the potential lung recruitment in ARDS.

At the lung level, the relationship between lung volume and pressure can be graphed through a pressure/volume (P/V) curve. In this curve, hysteresis (H) can be evaluated, which is the amount of energy generated during inspiration that is not recovered during expiration. H is related to recruitment, assuming that the greater H the greater the alveolar recruitment. For this reason, the objective of this study is the measurement of H as a way to assess the lung recruitment capacity, in patients with ARDS and in patients with Covid-19 who develop ARDS (ARDS- Covid)

Detailed description: During the first 7 days of the patient on mechanical ventilation (MV), measurements will be taken. For this, the patient will be in the supine position (DS) or the prone position (DP). The patient will be on a dose of analgesics, under sedation and muscle relaxation and will not present any respiratory stimulus.

Data from MV will also be recorded (prior to recruitment assessment): tidal volume (TV) in milliliters (ml), respiratory rate (RR) in a minute, fraction of inspired oxygen (FiO2), positive end-expiratory pressure (PEEP), in centimeters of water (cmH2O), plateau pressure (Pplat, measured after an end-inspiratory pause, cmH2O), mean airway pressure (PM, cmH2O), minute volume (calculated as the product of RR and TV) in milliliters per minute, ∆P (calculated as Pplat minus PEEP, cmH2O), static compliance (calculated as TV divided by ∆P, ml/cmH2O). Arterial blood gases will also be considered.

The proposed recruitment assessment will be the measurement of pulmonary hysteresis ratio. For measurements, a ventilator (Neumovent GraphNet Advance-TS, Córdoba Argentina) will be used. Additionally, a dedicated software connected to a computer will be used to perfThe evaluation of pressure in relation to volume will also be carried out, through the pressure/volume curve (PV curve), available in the respirator. A low-flow inflation and deflation PV curve from 0 up to 40 cm H2O and from 40 down to 0 cm H2O will be performed using the automatic tool on the ventilator (P/V tool; Neumovent GraphNet Advance-ts, Córdoba Argentina). The P-V curve can be visualized immediately on the screen of the mechanical ventilator and will be taken as a method to assess lung recruitment through the hysteresis-like behavior of the respiratory system. Inﬂation and deﬂation volume data will be corrected for changes in oxygen consumption.

Ratio hysteresis (RH) of the respiratory system will be measured by planimetry using SigmaPlot 12.0 software. There, through a cursor, for the measurement of hysteresis, the place where the volume was greater was drawn and the coincident pressure value was considered. Subsequently the ratio hysteresis will be calculated as the ratio between hysteresis and the product of the pressure span and the maximum volume reached (maximum hysteresis). Also, through the maximum distance between the inspiratory and expiratory limb of the curve weighted by the maximum volume, the normalized maximum distance (Vmax) is calculated. Recruitment potential will considered when there is a HR ≥ 28% and aVmax ≥ 41%.

Data Analysis. Categorical variables will be presented as number and percentage, while continuous variables will be presented as mean and standard deviation or median and interquartile range, as appropriate. The Chi2 test or Fisher's exact test will be used for qualitative variables and the Student test or the Mann-Whitney U test for quantitative variables. To evaluate correlation, the Pearson or Spearman test will be used, according to the distribution of the evaluated variables. A p ≤ 0.05 will be used.

Eligibility criteria: Inclusion Criteria:

- Patients who have been receiving MV with diagnosis of ARDS (Berlin definition) and ARDS-Covid-19.

Exclusion Criteria:

* Patients with chronic pulmonary disease
* Patients with a high risk of death within 3 months for reasons other than ARDS-Covid-19
* Patients having made the decision to withhold life-sustaining treatment.

Primary outcomes:
measure: Potential recruitment of patients with ARDS and ARDS-Covid-19
timeFrame: First 7 days of the patient on mechanical ventilation (MV)
Secondary outcomes:
measure: Assess the association between APACHE II (Acute Physiology And Chronic Health Evaluation) score and and potential recruitment
timeFrame: First 7 days of the patient on mechanical ventilation (MV)
measure: Assess the association between TV and potential recruitment
timeFrame: First 7 days of the patient on mechanical ventilation (MV)
measure: Assess the association between plateau pressure and potential recruitment
timeFrame: First 7 days of the patient on mechanical ventilation (MV)
measure: Assess the association between ΔP and potential recruitment
timeFrame: First 7 days of the patient on mechanical ventilation (MV)
measure: Assess the association between static compliance and potential recruitment
timeFrame: First 7 days of the patient on mechanical ventilation (MV)
measure: Assess the association between mechanical power and potential recruitment
timeFrame: First 7 days of the patient on mechanical ventilation (MV)
measure: Assess the association between PaO2/FiO2 and potential recruitment
timeFrame: First 7 days of the patient on mechanical ventilation (MV)
measure: Assess the association between PaCO2 and potential recruitment
timeFrame: First 7 days of the patient on mechanical ventilation (MV)
measure: Assess the association between ventilator free days (in days) and potential recruitment
timeFrame: First 7 days of the patient on mechanical ventilation (MV)
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Hospital Agudos Ramos Mejía
state: Buenos Aires
Study officials:
References:
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