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

NCT05248243 | Unknown

• 1 other identifier: Hospital General Ramos Mejía
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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)

Conditions

Acute Respiratory Distress Syndrome; COVID-19 Pneumonia; Recruitment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Assess the association between APACHE II (Acute Physiology And Chronic Health Evaluation) score and and potential recruitment

  First 7 days of the patient on mechanical ventilation (MV)

• Assess the association between TV and potential recruitment

  First 7 days of the patient on mechanical ventilation (MV)

• Assess the association between plateau pressure and potential recruitment

  First 7 days of the patient on mechanical ventilation (MV)

• Assess the association between ΔP and potential recruitment

  First 7 days of the patient on mechanical ventilation (MV)

• Assess the association between static compliance and potential recruitment

  First 7 days of the patient on mechanical ventilation (MV)

Interventions

Recruitment assessment PROCEDURE

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

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramos Mejía Hospital: lead

Study Sites (1)

Hospital Agudos Ramos Mejía

Ciudad Autonoma de Buenos Aire, Buenos Aires, C1221ADC, Argentina

RECRUITING

Related Publications (11)

• 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.

  PMID: 22797452 BACKGROUND

• 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.

  PMID: 32348678 BACKGROUND

• 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.

  PMID: 16641394 BACKGROUND

• 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.

  PMID: 32329799 BACKGROUND

• 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 Oct;48(10):1494-1502. doi: 10.1097/CCM.0000000000004518.

  PMID: 32897667 RESULT

• 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. Epub 2008 Jun 25.

  PMID: 18575846 RESULT

• 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: 10.1164/rccm.201702-0388LE. No abstract available.

  PMID: 28557528 RESULT

• 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.

  PMID: 3928249 RESULT

• 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. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016.

  PMID: 9824069 RESULT

• 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: 10.1097/00003246-200208000-00016.

  PMID: 12163791 RESULT

• Hohmann F, Wedekind L, Grundeis F, Dickel S, Frank J, Golinski M, Griesel M, Grimm C, Herchenhahn C, Kramer A, Metzendorf MI, Moerer O, Olbrich N, Thieme V, Vieler A, Fichtner F, Burns J, Laudi S. Early spontaneous breathing for acute respiratory distress syndrome in individuals with COVID-19. Cochrane Database Syst Rev. 2022 Jun 29;6(6):CD015077. doi: 10.1002/14651858.CD015077.

  PMID: 35767435 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Roberto Santa Cruz, Dr.

CONTACT

+5492966559019; resc.hrrg@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 21, 2022
• Study Start: March 7, 2022
• Primary Completion: March 7, 2023
• Study Completion: March 1, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)