Respiratory Distress Syndrome, AdultMPARDSNCT04157946
The Role of Morphological Phenotype in ARDS
An observational study of Respiratory Distress Syndrome, Adult, run by Hospital El Cruce at 1 site in Argentina.
Trial summary
Although most of the information focuses on understanding how the ventilator produces lung damage, the pulmonary factors that predispose to ventilator-induced lung injury (VILI) have been less studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- CT
- How many people
- 12 participants
- Where
- 1 siteArgentina
- Study dates
- 7 Aug 2017to 20 Jul 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate to severe ARDS diagnosis were studied according to the Berlin definition. The AECC defined ARDS as the acute onset of hypoxemia (arterial partial pressure of oxygen to fraction of inspired oxygen [PaO2/FIO2] ≤ 200 mm Hg) with bilateral infiltrates on frontal chest radiograph, with no evidence of left atrial hypertension.
Who may be able to join
- Acute respiratory distress syndrome (ARDS).
Who cannot join
- Emphysema Asthma Pneumothorax Oxygen saturation ≤ 88% Severe shock Ventricular arrhythmia Myocardial ischemia.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Assessment of Ventilator-induced Lung Injury in Patients With Acute Respiratory Distress Syndrome: The Role of Morphological Phenotype in ARDS
Although most of the information focuses on understanding how the ventilator produces lung damage, the pulmonary factors that predispose to ventilator-induced lung injury (VILI) have been less studied. Acute respiratory distress syndrome (ARDS) can adopt different morphological phenotypes, with its own clinical and mechanical characteristics. This morphological phenotypes may favor the development of VILI for same ventilatory strategy
Read the detailed description
The lung in acute respiratory distress syndrome ARDS) is a heterogeneous viscoelastic system, in which areas with different time constants coexist, causing tidal volume to be distributed unevenly within an anatomically and functionally reduced lung. The administration of a disproportionately high tidal volume for this lung predisposes to the over-distension of the better ventilated alveoli and to the injury by tidal opening and closing of the alveoli more unstable. In this sense, using low tidal volume and homogenizing the lung by means of the prone position have proven beneficial in ARDS.
Tidal volume, driving pressure, inspiratory flow and respiratory rate have been identified as responsible for mechanical ventilation-induced lung injury (VILI). These factors together represent the mechanical power, the insulting energy which is repeatedly applied to a vulnerable lung parenchyma.
Although most of the information focuses on understanding how the ventilator produces lung damage and/or amplifies the existing one, the pulmonary factors that predispose to VILI have been less studied. Acute respiratory distress syndrome can adopt different morphological phenotypes, with its own clinical and mechanical characteristics. Understanding how each subgroup of ARDS responds to the protective ventilatory strategy could help to personalize treatment.
Objectives: To compare the risk of VILI in two groups of ARDS with different morphological phenotypes (focal and non-focal), ventilated with the same protective strategy.
Design: Patients with ARDS were ventilated under the same conditions of both tidal volume (TV) and plateau pressure (PPlat). Positive End Expiratory Pressure (PEEP) was adjusted to reach 30 cmH2O of PPlat. A CT was performed in inspiration and expiration. Transpulmonary pressures (TP) were measured and lung volumes calculated (Volume Analysis Software,Toshiba, Japan). Stress was defined as TP at the end of inspiration (TPinsp) and strain: tidal volume/End Expiratory Lung Volume Patients were classified into focal and non-focal according to the distribution of aeration loss in CT. Mann - Whitney U test was used to compare variables and Pearson correlation coefficient to compare its correlation. Significant: p <0.05
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- CT
- Keywords
- Respiratory Insufficiency, Ventilator-Induced Lung Injury, Ventilators, Mechanical
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTDiagnostic test
Also called Transpulmonary pressures (TP) were measured
Patients with ARDS were included. We excluded patients with emphysema, asthma, pneumothorax, or serious conditions of instability: oxygen saturation ≤ 88%; severe shock, ventricular arrhythmia, or myocardial ischemia.
To allow comparison between groups, patients were ventilated in volume control under similar conditions of tidal volume (TV; 6 ml/kg-PBW), plateau pressure (PPlat 30 cmH2O), respiratory rate (18 bit/min) and constant flow. PEEP was adjusted to reach objective PPlat.
Transpulmonary pressures (TP) were measured and a chest CT scan performed during an expiratory and inspiratory pause. Global and regional volumes of lungs were measured using specific software (Volume Analysis Software,Toshiba, Japan). Three regions were identified: basal (from the diaphragm to the carina), middle (from the carina to the aortic arch) and apical (above the aortic arch).
| Study group | Role | What they receive |
|---|---|---|
| Focal | ARDS was classified according to the pattern that adopted the loss of aeration in the chest CT in the two groups: focal (predominant commitment in the dependant region) and non- focal (patched or diffused involvement of the entire lung) Receives: Diagnostic Test: CT | |
| Non-Focal | ARDS was classified according to the pattern that adopted the loss of aeration in the chest CT in the two groups: focal (predominant commitment in the dependant region) and non- focal (patched or diffused involvement of the entire lung) Receives: Diagnostic Test: CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the level of pulmonary stress caused by mechanical ventilation
Twelve patients with ARDS were studied (six from each group). A balloon catheter was placed at the distal end of the esophagus to measure esophageal pressures. A pneumotachograph was used to record and quantify esophageal pressures during the ventilatory cycle. Esophageal pressure is considered as equivalent of pleural pressure. Pulmonary distention pressure (transpulmonary pressure) is obtained by measuring the difference between the pressure of the respiratory system (supplied by mechanical ventilation) and esophageal pressure. Stress was defined as the transpulmonary pressure measure at the end of an inspiratory pause (in zero flow conditions). Pulmonary stress was quantified in cmH2O. There is a linear relationship between stress and lung damage (VILI). Mann-Whitney U test was used to compare variables. Significant p < 0.05.
Measured: One year
Measurement of pulmonary strain caused by mechanical ventilation
Twelve patients with ARDS were studied (six from each group). A chest tomography was performed during an expiratory and inspiratory pause. Using a specific software (Lung Volume Analysis Software.Toshiba, Japan), the amount of lung volume was calculated in expiration and inspiration air (expressed in ml). The strain was defined as the relationship between the amount of volume supplied by mechanical ventilation (tidal volume) and the lung's ability to receive that volume (EELV: end expiratory lung volume). This ratio was expressed as a percentage. There is a direct relationship between strain and lung damage (VILI). Mann-Whitney U test was used to compare variables. Significant p < 0.05..
Measured: One year
Measurement of injury due to cyclic opening and closing of the most unstable caused by mechanical ventilation .
Twelve patients with ARDS were studied (six from each group). Three lung regions were studied on tomography: Basal, middle and apical. A specific software quantified the amount of airless lung (100 to - 100 HU), both in expiration and inspiration. This amount was expressed in numbers of pixels. A lesion due to cyclic opening and closing of the alveoli was defined as the difference between the size of the airless lung between both respiratory times, in relation to the basal condition (lung without air at expiration). This ratio was expressed as a percentage. There is a direct relationship between this mechanism of damage and the risk of VILI. Mann-Whitney U test was used to compare variables. Significant p < 0.05.
Measured: One year
Secondary outcomes (1)
Measurement of pulmonary hyperinflation caused by mechanical ventilation
Twelve patients with ARDS were studied (six from each group). Lung regions were studied on tomography: Basal, middle and apical. A specific software was quantified the amount of excess air (hyperinflation:-900 to - 1000 HU). Hyperinflation was expressed in relation to the total lung volume as a percentage. There is a direct relationship between hyperinflation and the risk of VILI. Mann-Whitney U test was used to compare variables. Significant p < 0.05.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start7 Aug 2017
- Primary completion10 Jul 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital El Cruce
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nestor Pistillo, Hospital El Cruce
- Investigators
- Nestor Pistillo, MD, Principal investigator, Hospital El Cruce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157946
- Sponsor's protocol ID
- HElCruce
- Acronym
- MPARDS
- Status last verified
- Nov 2019
- First submitted
- 5 Nov 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guerin C, Beuret P, Constantin JM, Bellani G, Garcia-Olivares P, Roca O, Meertens JH, Maia PA, Becher T, Peterson J, Larsson A, Gurjar M, Hajjej Z, Kovari F, Assiri AH, Mainas E, Hasan MS, Morocho-Tutillo DR, Baboi L, Chretien JM, Francois G, Ayzac L, Chen L, Brochard L, Mercat A; investigators of the APRONET Study Group, the REVA Network, the Reseau recherche de la Societe Francaise d'Anesthesie-Reanimation (SFAR-recherche) and the ESICM Trials Group. A prospective international observational prevalence study on prone positioning of ARDS patients: the APRONET (ARDS Prone Position Network) study. Intensive Care Med. 2018 Jan;44(1):22-37. doi: 10.1007/s00134-017-4996-5. Epub 2017 Dec 7.
PubMed 29218379Protti A, Andreis DT, Monti M, Santini A, Sparacino CC, Langer T, Votta E, Gatti S, Lombardi L, Leopardi O, Masson S, Cressoni M, Gattinoni L. Lung stress and strain during mechanical ventilation: any difference between statics and dynamics? Crit Care Med. 2013 Apr;41(4):1046-55. doi: 10.1097/CCM.0b013e31827417a6.
PubMed 23385096Cressoni M, Cadringher P, Chiurazzi C, Amini M, Gallazzi E, Marino A, Brioni M, Carlesso E, Chiumello D, Quintel M, Bugedo G, Gattinoni L. Lung inhomogeneity in patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 2014 Jan 15;189(2):149-58. doi: 10.1164/rccm.201308-1567OC.
PubMed 24261322Gattinoni L, Marini JJ, Pesenti A, Quintel M, Mancebo J, Brochard L. The "baby lung" became an adult. Intensive Care Med. 2016 May;42(5):663-673. doi: 10.1007/s00134-015-4200-8. Epub 2016 Jan 18.
PubMed 26781952Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162Nieman GF, Satalin J, Andrews P, Habashi NM, Gatto LA. Lung stress, strain, and energy load: engineering concepts to understand the mechanism of ventilator-induced lung injury (VILI). Intensive Care Med Exp. 2016 Dec;4(1):16. doi: 10.1186/s40635-016-0090-5. Epub 2016 Jun 18.
PubMed 27316442Retamal J, Hurtado D, Villarroel N, Bruhn A, Bugedo G, Amato MBP, Costa ELV, Hedenstierna G, Larsson A, Borges JB. Does Regional Lung Strain Correlate With Regional Inflammation in Acute Respiratory Distress Syndrome During Nonprotective Ventilation? An Experimental Porcine Study. Crit Care Med. 2018 Jun;46(6):e591-e599. doi: 10.1097/CCM.0000000000003072.
PubMed 29528946ARDS 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 22797452
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Assessment of Ventilator-induced Lung Injury in Patients With Acute Respiratory Distress Syndrome: The Role of Morphological Phenotype in ARDS
- ClinicalTrials.gov ID
- NCT04157946
- Acronym / sponsor ID
- MPARDS / HElCruce
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Respiratory Insufficiency, Ventilator-Induced Lung Injury, Ventilators, Mechanical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospital El CruceUniversity, hospital or other
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 8 Nov 2019 (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.
Although most of the information focuses on understanding how the ventilator produces lung damage, the pulmonary factors that predispose to ventilator-induced lung injury (VILI) have been less studied. Acute respiratory distress syndrome (ARDS) can adopt different morphological phenotypes, with its own clinical and mechanical characteristics. This morphological phenotypes may favor the development of VILI for same ventilatory strategy
Detailed description
The lung in acute respiratory distress syndrome ARDS) is a heterogeneous viscoelastic system, in which areas with different time constants coexist, causing tidal volume to be distributed unevenly within an anatomically and functionally reduced lung. The administration of a disproportionately high tidal volume for this lung predisposes to the over-distension of the better ventilated alveoli and to the injury by tidal opening and closing of the alveoli more unstable. In this sense, using low tidal volume and homogenizing the lung by means of the prone position have proven beneficial in ARDS.
Tidal volume, driving pressure, inspiratory flow and respiratory rate have been identified as responsible for mechanical ventilation-induced lung injury (VILI). These factors together represent the mechanical power, the insulting energy which is repeatedly applied to a vulnerable lung parenchyma.
Although most of the information focuses on understanding how the ventilator produces lung damage and/or amplifies the existing one, the pulmonary factors that predispose to VILI have been less studied. Acute respiratory distress syndrome can adopt different morphological phenotypes, with its own clinical and mechanical characteristics. Understanding how each subgroup of ARDS responds to the protective ventilatory strategy could help to personalize treatment.
Objectives: To compare the risk of VILI in two groups of ARDS with different morphological phenotypes (focal and non-focal), ventilated with the same protective strategy.
Design: Patients with ARDS were ventilated under the same conditions of both tidal volume (TV) and plateau pressure (PPlat). Positive End Expiratory Pressure (PEEP) was adjusted to reach 30 cmH2O of PPlat. A CT was performed in inspiration and expiration. Transpulmonary pressures (TP) were measured and lung volumes calculated (Volume Analysis Software,Toshiba, Japan). Stress was defined as TP at the end of inspiration (TPinsp) and strain: tidal volume/End Expiratory Lung Volume Patients were classified into focal and non-focal according to the distribution of aeration loss in CT. Mann - Whitney U test was used to compare variables and Pearson correlation coefficient to compare its correlation. Significant: p <0.05
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focal | – | Diagnostic Test: CTARDS was classified according to the pattern that adopted the loss of aeration in the chest CT in the two groups: focal (predominant commitment in the dependant region) and non- focal (patched or diffused involvement of the entire lung) |
| Non-Focal | – | Diagnostic Test: CTARDS was classified according to the pattern that adopted the loss of aeration in the chest CT in the two groups: focal (predominant commitment in the dependant region) and non- focal (patched or diffused involvement of the entire lung) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe ARDS diagnosis were studied according to the Berlin definition. The AECC defined ARDS as the acute onset of hypoxemia (arterial partial pressure of oxygen to fraction of inspired oxygen [PaO2/FIO2] ≤ 200 mm Hg) with bilateral infiltrates on frontal chest radiograph, with no evidence of left atrial hypertension.
Key inclusion criteria (1 listed)
- Acute respiratory distress syndrome (ARDS).
Key exclusion criteria (2 listed)
- Emphysema Asthma Pneumothorax Oxygen saturation ≤ 88% Severe shock Ventricular arrhythmia Myocardial ischemia.
- -
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 |
|---|---|---|
| CTAlso: Transpulmonary pressures (TP) were measuredPatients with ARDS were included. We excluded patients with emphysema, asthma, pneumothorax, or serious conditions of instability: oxygen saturation ≤ 88%; severe shock, ventricular arrhythmia, or myocardial ischemia. To allow comparison between groups, patients were ventilated in volume control under similar conditions of tidal volume (TV; 6 ml/kg-PBW), plateau pressure (PPlat 30 cmH2O), respiratory rate (18 bit/min) and constant flow. PEEP was adjusted to reach objective PPlat. Transpulmonary pressures (TP) were measured and a chest CT scan performed during an expiratory and inspiratory pause. Global and regional volumes of lungs were measured using specific software (Volume Analysis Software,Toshiba, Japan). Three regions were identified: basal (from the diaphragm to the carina), middle (from the carina to the aortic arch) and apical (above the aortic arch). | Diagnostic test | Focal, Non-Focal |
Primary outcome
Measuring the level of pulmonary stress caused by mechanical ventilation
Time frame: One year
Twelve patients with ARDS were studied (six from each group). A balloon catheter was placed at the distal end of the esophagus to measure esophageal pressures. A pneumotachograph was used to record and quantify esophageal pressures during the ventilatory cycle. Esophageal pressure is considered as equivalent of pleural pressure. Pulmonary distention pressure (transpulmonary pressure) is obtained by measuring the difference between the pressure of the respiratory system (supplied by mechanical ventilation) and esophageal pressure. Stress was defined as the transpulmonary pressure measure at the end of an inspiratory pause (in zero flow conditions). Pulmonary stress was quantified in cmH2O. There is a linear relationship between stress and lung damage (VILI). Mann-Whitney U test was used to compare variables. Significant p < 0.05.
Measurement of pulmonary strain caused by mechanical ventilation
Time frame: One year
Twelve patients with ARDS were studied (six from each group). A chest tomography was performed during an expiratory and inspiratory pause. Using a specific software (Lung Volume Analysis Software.Toshiba, Japan), the amount of lung volume was calculated in expiration and inspiration air (expressed in ml). The strain was defined as the relationship between the amount of volume supplied by mechanical ventilation (tidal volume) and the lung's ability to receive that volume (EELV: end expiratory lung volume). This ratio was expressed as a percentage. There is a direct relationship between strain and lung damage (VILI). Mann-Whitney U test was used to compare variables. Significant p < 0.05..
Measurement of injury due to cyclic opening and closing of the most unstable caused by mechanical ventilation .
Time frame: One year
Twelve patients with ARDS were studied (six from each group). Three lung regions were studied on tomography: Basal, middle and apical. A specific software quantified the amount of airless lung (100 to - 100 HU), both in expiration and inspiration. This amount was expressed in numbers of pixels. A lesion due to cyclic opening and closing of the alveoli was defined as the difference between the size of the airless lung between both respiratory times, in relation to the basal condition (lung without air at expiration). This ratio was expressed as a percentage. There is a direct relationship between this mechanism of damage and the risk of VILI. Mann-Whitney U test was used to compare variables. Significant p < 0.05.
1 secondary outcome
Measurement of pulmonary hyperinflation caused by mechanical ventilation
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Background: PubMed 29218379Guerin C, Beuret P, Constantin JM, Bellani G, Garcia-Olivares P, Roca O, Meertens JH, Maia PA, Becher T, Peterson J, Larsson A, Gurjar M, Hajjej Z, Kovari F, Assiri AH, Mainas E, Hasan MS, Morocho-Tutillo DR, Baboi L, Chretien JM, Francois G, Ayzac L, Chen L, Brochard L, Mercat A; investigators of the APRONET Study Group, the REVA Network, the Reseau recherche de la Societe Francaise d'Anesthesie-Reanimation (SFAR-recherche) and the ESICM Trials Group. A prospective international observational prevalence study on prone positioning of ARDS patients: the APRONET (ARDS Prone Position Network) study. Intensive Care Med. 2018 Jan;44(1):22-37. doi: 10.1007/s00134-017-4996-5. Epub 2017 Dec 7.
- Background: PubMed 23385096Protti A, Andreis DT, Monti M, Santini A, Sparacino CC, Langer T, Votta E, Gatti S, Lombardi L, Leopardi O, Masson S, Cressoni M, Gattinoni L. Lung stress and strain during mechanical ventilation: any difference between statics and dynamics? Crit Care Med. 2013 Apr;41(4):1046-55. doi: 10.1097/CCM.0b013e31827417a6.
- Background: PubMed 24261322Cressoni M, Cadringher P, Chiurazzi C, Amini M, Gallazzi E, Marino A, Brioni M, Carlesso E, Chiumello D, Quintel M, Bugedo G, Gattinoni L. Lung inhomogeneity in patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 2014 Jan 15;189(2):149-58. doi: 10.1164/rccm.201308-1567OC.
- Background: PubMed 26781952Gattinoni L, Marini JJ, Pesenti A, Quintel M, Mancebo J, Brochard L. The "baby lung" became an adult. Intensive Care Med. 2016 May;42(5):663-673. doi: 10.1007/s00134-015-4200-8. Epub 2016 Jan 18.
- Background: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Background: PubMed 27316442Nieman GF, Satalin J, Andrews P, Habashi NM, Gatto LA. Lung stress, strain, and energy load: engineering concepts to understand the mechanism of ventilator-induced lung injury (VILI). Intensive Care Med Exp. 2016 Dec;4(1):16. doi: 10.1186/s40635-016-0090-5. Epub 2016 Jun 18.
- Background: PubMed 29528946Retamal J, Hurtado D, Villarroel N, Bruhn A, Bugedo G, Amato MBP, Costa ELV, Hedenstierna G, Larsson A, Borges JB. Does Regional Lung Strain Correlate With Regional Inflammation in Acute Respiratory Distress Syndrome During Nonprotective Ventilation? An Experimental Porcine Study. Crit Care Med. 2018 Jun;46(6):e591-e599. doi: 10.1097/CCM.0000000000003072.
- Results publication: 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.
- 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.
Nestor Pistillo, MD principal investigator
Hospital El Cruce
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 Respiratory Distress Syndrome, Adult, run by Hospital El Cruce 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 2 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: finished, as of the sponsor's last update on 8 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the level of pulmonary stress caused by mechanical ventilation (time frame: One year). The study lists 3 primary outcomes in all. 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 NCT04157946, which also lists 8 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 8 Nov 2019.