Recruitment Assessment in Patients With Acute Respiratory Distress Syndrome and Covid-19

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Recruitment Assessment in Patients With Acute Respiratory Distress Syndrome and Covid-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05248243
• Other study ID #: Hospital General Ramos Mejía
• Status: Recruiting
• Start date: March 7, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: November 2023
• Source: Ramos Mejía Hospital
• Contact: Roberto Santa Cruz, Dr.
• Phone: +5492966559019
• Email: resc.hrrg[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: March 1, 2025
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID-19
• COVID-19 Pneumonia
• Recruitment
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Procedure:
• Recruitment assessment
Intervention Details: Construction of the P/V curve with subsequent measurement of HR and Vmax.

Locations

Country	Name	City	State
Argentina	Hospital Agudos Ramos Mejía	Ciudad Autonoma de Buenos Aire	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Ramos Mejía Hospital

Country where clinical trial is conducted

Argentina, 

References & Publications (10)

ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669. — View Citation

Chen L, Del Sorbo L, Grieco DL, Shklar O, Junhasavasdikul D, Telias I, Fan E, Brochard L. Airway Closure in Acute Respiratory Distress Syndrome: An Underestimated and Misinterpreted Phenomenon. Am J Respir Crit Care Med. 2018 Jan 1;197(1):132-136. doi: 10 — View Citation

Chiumello D, Arnal JM, Umbrello M, Cammaroto A, Formenti P, Mistraletti G, Bolgiaghi L, Gotti M, Novotni D, Reidt S, Froio S, Coppola S. Hysteresis and Lung Recruitment in Acute Respiratory Distress Syndrome Patients: A CT Scan Study. Crit Care Med. 2020 — View Citation

Demory D, Arnal JM, Wysocki M, Donati S, Granier I, Corno G, Durand-Gasselin J. Recruitability of the lung estimated by the pressure volume curve hysteresis in ARDS patients. Intensive Care Med. 2008 Nov;34(11):2019-25. doi: 10.1007/s00134-008-1167-8. Epu — View Citation

Gattinoni L, Caironi P, Cressoni M, Chiumello D, Ranieri VM, Quintel M, Russo S, Patroniti N, Cornejo R, Bugedo G. Lung recruitment in patients with the acute respiratory distress syndrome. N Engl J Med. 2006 Apr 27;354(17):1775-86. doi: 10.1056/NEJMoa052052. — View Citation

Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29. — View Citation

Marini JJ, Gattinoni L. Management of COVID-19 Respiratory Distress. JAMA. 2020 Jun 9;323(22):2329-2330. doi: 10.1001/jama.2020.6825. No abstract available. — View Citation

Schoenfeld DA, Bernard GR; ARDS Network. Statistical evaluation of ventilator-free days as an efficacy measure in clinical trials of treatments for acute respiratory distress syndrome. Crit Care Med. 2002 Aug;30(8):1772-7. doi: 10.1097/00003246-200208000- — View Citation

Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Workin — View Citation

Ziehr DR, Alladina J, Petri CR, Maley JH, Moskowitz A, Medoff BD, Hibbert KA, Thompson BT, Hardin CC. Respiratory Pathophysiology of Mechanically Ventilated Patients with COVID-19: A Cohort Study. Am J Respir Crit Care Med. 2020 Jun 15;201(12):1560-1564. doi: 10.1164/rccm.202004-1163LE. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Potential recruitment of patients with ARDS and ARDS-Covid-19	Recruitment potential will considered when there is a HR = 28% and Vmax = 41%.	First 7 days of the patient on mechanical ventilation (MV)
Secondary	Assess the association between APACHE II (Acute Physiology And Chronic Health Evaluation) score and and potential recruitment	Assess the correlation between APACHE and potential recruitment (HR = 28% and Vmax = 41%).; Tidal volume and pressure will be combined to report the Recruitment Index (R/I) in mL/cmH2O.; A threshold of 0.5 will be used to de?ne high recruitability (R/I ratio >= 0.5 ml/cmH2O) and low recruitability (R/I ratio < 0.5 ml/cmH2O).	First 7 days of the patient on mechanical ventilation (MV)
Secondary	Assess the association between TV and potential recruitment	Assess the correlation between TV and potential recruitment (HR = 28% and Vmax = 41%).	First 7 days of the patient on mechanical ventilation (MV)
Secondary	Assess the association between plateau pressure and potential recruitment	Assess the correlation between plateau pressure and potential recruitment (HR = 28% and Vmax = 41%).; Oxygenation: PaO2/FiO2 (ratio between arterial oxygen pressure and inspired fraction of oxygen).; Static compliance (cmH2O); Plateau pressure (cmH2O); ?P (ml/cmH2O); Tidal volume and pressure will be combined to report the Recruitment Index (R/I) in mL/cmH2O.	First 7 days of the patient on mechanical ventilation (MV)
Secondary	Assess the association between ?P and potential recruitment	Assess the correlation between ?P and potential recruitment (HR = 28% and Vmax = 41%).	First 7 days of the patient on mechanical ventilation (MV)
Secondary	Assess the association between static compliance and potential recruitment	Assess the correlation between static compliance and potential recruitment (HR = 28% and Vmax = 41%).	First 7 days of the patient on mechanical ventilation (MV)
Secondary	Assess the association between mechanical power and potential recruitment	Assess the correlation between mechanical power and potential recruitment (HR = 28% and Vmax = 41%).	First 7 days of the patient on mechanical ventilation (MV)
Secondary	Assess the association between PaO2/FiO2 and potential recruitment	Assess the correlation between PaO2/FiO2 and potential recruitment (HR = 28% and Vmax = 41%).	First 7 days of the patient on mechanical ventilation (MV)
Secondary	Assess the association between PaCO2 and potential recruitment	Assess the correlation between PaCO2 and potential recruitment (HR = 28% and Vmax = 41%).	First 7 days of the patient on mechanical ventilation (MV)
Secondary	Assess the association between ventilator free days (in days) and potential recruitment	Assess the correlation between ventilator free days (in days) and potential recruitment (HR = 28% and Vmax = 41%).	First 7 days of the patient on mechanical ventilation (MV)