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

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ClinicalTrials.gov Identifier: NCT05248243
Recruitment Status : Recruiting
First Posted : February 21, 2022
Last Update Posted : March 22, 2022
Sponsor:
Information provided by (Responsible Party):
Roberto Santa Cruz, Ramos Mejía Hospital

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. Recently, a new index based on lung compliance has been described to directly quantify the potential for lung recruitment, called the recruitment-inflation index (R/I index). The objective of this study is to prospectively evaluate the recruitment capacity in patients with ARDS and ARDS-Covid-19.

Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome COVID-19 Pneumonia Recruitment Procedure: Recruitment assessment

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Study Type : Observational
Estimated Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Recruitment Assessment in Patients With Acute Respiratory Distress Syndrome and Covid-19
Actual Study Start Date : March 7, 2022
Actual Primary Completion Date : March 7, 2022
Estimated Study Completion Date : March 1, 2025



Intervention Details:
  • Procedure: Recruitment assessment
    TV exhaled from high to low PEEP (difference of 10 cm of H2O),during a single maneuver (TVeHL). The measurement will be performed with a high level of PEEP (PEEPH), with values between 15 and 18 cmH2O and a low level of PEEP (PEEPL) with values between 5 and 8 cmH2O. Pplat in PEEPL will also be measured.


Primary Outcome Measures :
  1. Potential recruitment of patients with ARDS and ARDS-Covid-19 [ Time Frame: First 7 days of the patient on mechanical ventilation (MV) ]

    To determine the Recruitment Index (R/I) of patients with ARDS and ARDS-Covid-19.

    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 define high recruitability (R/I ratio >= 0.5 ml/cmH2O) and low recruitability (R/I ratio < 0.5 ml/cmH2O).



Secondary Outcome Measures :
  1. To compare the potential recruitment in the supine position (SD) and in the prone position (PD). [ Time Frame: First 7 days of the patient on mechanical ventilation (MV) ]

    To compare the R/I (ml/cmH2O) in patients with ARDS and ARDS-Covid-19 in the supine position (SD) and in the prone position (PD).

    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 define high recruitability (R/I ratio >= 0.5 ml/cmH2O) and low recruitability (R/I ratio < 0.5 ml/cmH2O).


  2. Correlation between recruitment index (RI) and recruitment assessed by hysteresis ratio. [ Time Frame: First 7 days of the patient on mechanical ventilation (MV) ]

    Assess the correlation between recruitment index (RI) and recruitment assessed by the hysteresis ratio (hysteresis and the product of the pressure span and the maximum volume reached (maximum hysteresis) in ml/cmH2O

    Tidal volume and pressure will be combined to report the Recruitment Index (R/I) in mL/cmH2O.

    Tidal volume and pressure will be combined to report the hysteresis ratio in mL/cmH2O.


  3. Assess the relationship between potential recruitment with respiratory parameters. [ Time Frame: First 7 days of the patient on mechanical ventilation (MV) ]

    Assess the correlation between IR and respiratory parameters

    • 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.


  4. Assess the relationship between potential recruitment and clinical parameters. [ Time Frame: First 7 days of the patient on mechanical ventilation (MV) ]

    Assess the correlation between IR and clinical parameters:

    • Symptom onset date (FIS) (in case of ARDS-Covid-19)
    • APACHE II (Acute Physiology And Chronic Health Evaluation) score
    • SOFA (Sequential Organ Failure Assessment Score) score
    • Ventilator free days (in days)

    Tidal volume and pressure will be combined to report the Recruitment Index (R/I) in mL/cmH2O.




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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05248243


Contacts
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Contact: Roberto Santa Cruz, Dr. +5492966559019 resc.hrrg@gmail.com

Locations
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Argentina
Hospital Agudos Ramos Mejía Recruiting
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1221ADC
Contact: Roberto Santa Cruz, Dr.    +5492966559019    resc.hrrg@gmail.com   
Sponsors and Collaborators
Ramos Mejía Hospital
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Roberto Santa Cruz, Principal Investigator, Ramos Mejía Hospital
ClinicalTrials.gov Identifier: NCT05248243    
Other Study ID Numbers: Hospital General Ramos Mejía
First Posted: February 21, 2022    Key Record Dates
Last Update Posted: March 22, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury