Acute Respiratory Distress SyndromeNCT05248243
Recruitment Assessment in Patients With Acute Respiratory Distress Syndrome and Covid-19
An observational study of Acute Respiratory Distress Syndrome and COVID-19 Pneumonia, run by Ramos Mejía Hospital at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, COVID-19 Pneumonia, Recruitment
- What is being tested?
- Recruitment assessment
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- 1 siteArgentina
- Study dates
- 7 Mar 2022to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients who have been receiving MV with diagnosis of ARDS (Berlin definition) and ARDS-Covid-19.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Agudos Ramos Mejía
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1221ADC
Roberto Santa Cruz, Dr., +5492966559019, resc.hrrg@gmail.com
About this study
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)
Read the 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.
- Being tested
- Recruitment assessment
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recruitment assessmentProcedure or surgery
Intervention Details:
Construction of the P/V curve with subsequent measurement of HR and Vmax.
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential recruitment of patients with ARDS and ARDS-Covid-19
Recruitment potential will considered when there is a HR ≥ 28% and Vmax ≥ 41%.
Measured: 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
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 define high recruitability (R/I ratio >= 0.5 ml/cmH2O) and low recruitability (R/I ratio < 0.5 ml/cmH2O).
Measured: First 7 days of the patient on mechanical ventilation (MV)
Assess the association between TV and potential recruitment
Assess the correlation between TV and potential recruitment (HR ≥ 28% and Vmax ≥ 41%).
Measured: First 7 days of the patient on mechanical ventilation (MV)
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.
Measured: First 7 days of the patient on mechanical ventilation (MV)
Assess the association between ΔP and potential recruitment
Assess the correlation between ΔP and potential recruitment (HR ≥ 28% and Vmax ≥ 41%).
Measured: First 7 days of the patient on mechanical ventilation (MV)
Assess the association between static compliance and potential recruitment
Assess the correlation between static compliance and potential recruitment (HR ≥ 28% and Vmax ≥ 41%).
Measured: First 7 days of the patient on mechanical ventilation (MV)
Assess the association between mechanical power and potential recruitment
Assess the correlation between mechanical power and potential recruitment (HR ≥ 28% and Vmax ≥ 41%).
Measured: First 7 days of the patient on mechanical ventilation (MV)
Assess the association between PaO2/FiO2 and potential recruitment
Assess the correlation between PaO2/FiO2 and potential recruitment (HR ≥ 28% and Vmax ≥ 41%).
Measured: First 7 days of the patient on mechanical ventilation (MV)
Assess the association between PaCO2 and potential recruitment
Assess the correlation between PaCO2 and potential recruitment (HR ≥ 28% and Vmax ≥ 41%).
Measured: First 7 days of the patient on mechanical ventilation (MV)
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%).
Measured: First 7 days of the patient on mechanical ventilation (MV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start7 Mar 2022
- Primary completion7 Mar 2023
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramos Mejía Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Santa Cruz, Ramos Mejía Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248243
- Sponsor's protocol ID
- Hospital General Ramos Mejía
- Status last verified
- Nov 2023
- First submitted
- 15 Feb 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22797452Ziehr 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.
PubMed 32348678Gattinoni 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.
PubMed 16641394Marini 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.
PubMed 32329799Chiumello 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.
PubMed 32897667Demory 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.
PubMed 18575846Chen 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.
PubMed 28557528Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
PubMed 3928249Vincent 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.
PubMed 9824069Schoenfeld 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.
PubMed 12163791Hohmann 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.
PubMed 35767435
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recruitment Assessment in Patients With Acute Respiratory Distress Syndrome and Covid-19
- ClinicalTrials.gov ID
- NCT05248243
- Acronym / sponsor ID
- Hospital General Ramos Mejía
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Ramos Mejía HospitalUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients who have been receiving MV with diagnosis of ARDS (Berlin definition) and ARDS-Covid-19.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recruitment assessmentIntervention Details: Construction of the P/V curve with subsequent measurement of HR and Vmax. | Procedure or surgery | – |
Primary outcome
Potential recruitment of patients with ARDS and ARDS-Covid-19
Time frame: First 7 days of the patient on mechanical ventilation (MV)
Recruitment potential will considered when there is a HR ≥ 28% and Vmax ≥ 41%.
9 secondary outcomes
Assess the association between APACHE II (Acute Physiology And Chronic Health Evaluation) score and and potential recruitment
Time frame: First 7 days of the patient on mechanical ventilation (MV)
Assess the association between TV and potential recruitment
Time frame: First 7 days of the patient on mechanical ventilation (MV)
Assess the association between plateau pressure and potential recruitment
Time frame: First 7 days of the patient on mechanical ventilation (MV)
Assess the association between ΔP and potential recruitment
Time frame: First 7 days of the patient on mechanical ventilation (MV)
Assess the association between static compliance and potential recruitment
Time frame: First 7 days of the patient on mechanical ventilation (MV)
Assess the association between mechanical power and potential recruitment
Time frame: First 7 days of the patient on mechanical ventilation (MV)
Assess the association between PaO2/FiO2 and potential recruitment
Time frame: First 7 days of the patient on mechanical ventilation (MV)
Assess the association between PaCO2 and potential recruitment
Time frame: First 7 days of the patient on mechanical ventilation (MV)
Assess the association between ventilator free days (in days) and potential recruitment
Time frame: First 7 days of the patient on mechanical ventilation (MV)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Background: PubMed 22797452ARDS 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.
- Background: PubMed 32348678Ziehr 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.
- Background: PubMed 16641394Gattinoni 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.
- Background: PubMed 32329799Marini 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.
- Results publication: PubMed 32897667Chiumello 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.
- Results publication: PubMed 18575846Demory 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.
- Results publication: PubMed 28557528Chen 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.
- Results publication: PubMed 3928249Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
- Results publication: PubMed 9824069Vincent 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.
- Results publication: PubMed 12163791Schoenfeld 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.
- Derived from this study: PubMed 35767435Hohmann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and COVID-19 Pneumonia, run by Ramos Mejía Hospital at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Santa Cruz, Dr. (+5492966559019, resc.hrrg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential recruitment of patients with ARDS and ARDS-Covid-19 (time frame: First 7 days of the patient on mechanical ventilation (MV)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05248243, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.