Severe Acute Respiratory Distress Syndrome / Severe ARDSENCODENCT02617914
Hemodynamic and Cardiac Effects of Individualized PEEP Titration Using Esophageal Pressure Measurements in ARDS Patients
An observational study of Severe Acute Respiratory Distress Syndrome / Severe ARDS and Invasive Mechanical Ventilation, run by RWTH Aachen University.
Trial summary
The acute respiratory distress syndrome (ARDS) is common condition in critical ill patients affecting 7.2 people / 100,000 population / year and more than 7% of patients with invasive mechanical ventilation for more than 24 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Distress Syndrome / Severe ARDS, Invasive Mechanical Ventilation, Individualized PEEP Treatment Strategy
- What is being tested?
- individualized PEEP treatment, Invasive mechanical ventilation, ECMO,
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2018
- 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: Adult patients referred to our ICU (Criitical Care Unit) for treatment of ARDS of any cause with a P/F ratio < 150 and indication for continued maximum critical care therapy. Patients of childbearing age with ARDS will be included.
Who may be able to join
- Patients referred to our ICU for treatment of ARDS of any cause with a P/F ratio < 150 and indication for continued maximum critical care therapy
- Male or female aged > 18 years
- Written informed consent prior to study participation
- The subject is willing and able to follow the procedures outlined in the protocol
Who cannot join
- Patients admitted for primarily left ventricular or biventricular heart failure who are exclusively in need of cardiac and not pulmonary mechanical assist
- Pregnant and lactating females
- Patient has been committed to an institution by legal or regulatory order
- Participation in a parallel interventional clinical trial
- The subject received an investigational drug within 30 days prior to inclusion into this study
About this study
The acute respiratory distress syndrome (ARDS) is common condition in critical ill patients affecting 7.2 people / 100,000 population / year and more than 7% of patients with invasive mechanical ventilation for more than 24 hours. ARDS carries a high hospital mortality of up to 48% and consumes large amounts of critical care resources. ARDS patients often present with severe hypoxemia that is refractory to conventional treatment and are thus evaluated for extracorporeal membrane oxygenation (ECMO). However, uncertainty regarding the appropriate indication for ECMO and clinical evidence for ECMO as a rescue treatment are still controversial. In 2012 Grasso and colleagues therefore presented a case series of influenza A (H1N1) ARDS patients describing the use of esophageal pressure measurements for individualized PEEP titration to achieve an end expiratory plateau pressure of the lung (PPLATL) of 25cm H2O. After performing the measurements in 14 patients, ventilator settings could be adjusted in half of these patients by increasing PEEP which resulted in an increase of oxygenation measures to an extend that criteria for extracorporeal support where no longer met and conventional treatment with invasive mechanical ventilation could be continued. However, uncertainty remains as to whether these results are generalizable to ARDS of any cause. In addition, increasing PEEP might impact on cardiac function and might therefore be associated with clinical important hemodynamic effects in these patients.
The investigators aim to evaluate hemodynamic changes in patients with severe ARDS in which an individualized PEEP treatment strategy can be employed. ARDS will be defined and stratified according to the Berlin ARDS definition. A naso-gastric probe capable of measuring esophageal pressure will be inserted directly after admission to the ICU as previously described. Invasive mechanical ventilation and oesophageal pressure measurements will be done using the GE Healthcare Carescape R860 ventilator. A pulmonary artery catheters (Edwards CCOcomb) will be inserted to evaluate the hemodynamic parameters of cardiac output, pulmonary artery pressures and left atrial pressures. Volumetric parameters will be measured using tanspulmonary thermodilution devices (Edwards EV1000). Cardiac function will be addressed in addition by the use of a predefined echocardiography protocol.
- Conditions
- Severe Acute Respiratory Distress Syndrome / Severe ARDS, Invasive Mechanical Ventilation, Individualized PEEP Treatment Strategy
- Being tested
- individualized PEEP treatment, Invasive mechanical ventilation, ECMO,
- Keywords
- ARDS, PEEP, ECMO
- 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.
individualized PEEP treatment, Invasive mechanical ventilation, ECMO,Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic changes in parameters of cardiac output
Measured: Within the first 6 hours after ICU admission
Hemodynamic changes in parameters of pulmonary artery pressure
Measured: Within the first 6 hours after ICU admission
Hemodynamic changes in parameters of left atrial pressures
Measured: Within the first 6 hours after ICU admission
Hemodynamic changes in volumetric parameters
Measured: Within the first 6 hours after ICU admission
Secondary outcomes (5)
ICU length of stay
Measured: Within 28 days after ICU admission
Time of ventilator
Measured: Within 28 days after ICU admission
Necessity of ECMO support
Measured: Within 28 days after ICU admission
Hospital length of stay
Measured: Within 28 days after ICU admission
28-day mortality
Measured: Within 28 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: No approval from EC obtained. More details for study were required by EC.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Severe Acute Respiratory Distress Syndrome / Severe ARDSStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Kersten, MD, Principal investigator, Department of Cardiology, Pneumology, Vascular Medicine and Critical Care (Medical Clinic I), University Hospital Aachen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617914
- Sponsor's protocol ID
- 15-122
- Acronym
- ENCODE
- Status last verified
- Apr 2017
- First submitted
- 23 Nov 2015
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Villar J, Blanco J, Anon JM, Santos-Bouza A, Blanch L, Ambros A, Gandia F, Carriedo D, Mosteiro F, Basaldua S, Fernandez RL, Kacmarek RM; ALIEN Network. The ALIEN study: incidence and outcome of acute respiratory distress syndrome in the era of lung protective ventilation. Intensive Care Med. 2011 Dec;37(12):1932-41. doi: 10.1007/s00134-011-2380-4. Epub 2011 Oct 14.
PubMed 21997128Ferguson ND, Fan E, Camporota L, Antonelli M, Anzueto A, Beale R, Brochard L, Brower R, Esteban A, Gattinoni L, Rhodes A, Slutsky AS, Vincent JL, Rubenfeld GD, Thompson BT, Ranieri VM. The Berlin definition of ARDS: an expanded rationale, justification, and supplementary material. Intensive Care Med. 2012 Oct;38(10):1573-82. doi: 10.1007/s00134-012-2682-1. Epub 2012 Aug 25.
PubMed 22926653Roch A, Lepaul-Ercole R, Grisoli D, Bessereau J, Brissy O, Castanier M, Dizier S, Forel JM, Guervilly C, Gariboldi V, Collart F, Michelet P, Perrin G, Charrel R, Papazian L. Extracorporeal membrane oxygenation for severe influenza A (H1N1) acute respiratory distress syndrome: a prospective observational comparative study. Intensive Care Med. 2010 Nov;36(11):1899-905. doi: 10.1007/s00134-010-2021-3. Epub 2010 Aug 19.
PubMed 20721530Noah MA, Peek GJ, Finney SJ, Griffiths MJ, Harrison DA, Grieve R, Sadique MZ, Sekhon JS, McAuley DF, Firmin RK, Harvey C, Cordingley JJ, Price S, Vuylsteke A, Jenkins DP, Noble DW, Bloomfield R, Walsh TS, Perkins GD, Menon D, Taylor BL, Rowan KM. Referral to an extracorporeal membrane oxygenation center and mortality among patients with severe 2009 influenza A(H1N1). JAMA. 2011 Oct 19;306(15):1659-68. doi: 10.1001/jama.2011.1471. Epub 2011 Oct 5.
PubMed 21976615Hubmayr RD, Farmer JC. Should we "rescue" patients with 2009 influenza A(H1N1) and lung injury from conventional mechanical ventilation? Chest. 2010 Apr;137(4):745-7. doi: 10.1378/chest.09-2915. No abstract available.
PubMed 20371522Mitchell MD, Mikkelsen ME, Umscheid CA, Lee I, Fuchs BD, Halpern SD. A systematic review to inform institutional decisions about the use of extracorporeal membrane oxygenation during the H1N1 influenza pandemic. Crit Care Med. 2010 Jun;38(6):1398-404. doi: 10.1097/CCM.0b013e3181de45db.
PubMed 20400902Grasso S, Terragni P, Birocco A, Urbino R, Del Sorbo L, Filippini C, Mascia L, Pesenti A, Zangrillo A, Gattinoni L, Ranieri VM. ECMO criteria for influenza A (H1N1)-associated ARDS: role of transpulmonary pressure. Intensive Care Med. 2012 Mar;38(3):395-403. doi: 10.1007/s00134-012-2490-7. Epub 2012 Feb 10.
PubMed 22323077Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.
PubMed 24467647Dalton HJ, MacLaren G. Extracorporeal membrane oxygenation in pandemic flu: insufficient evidence or worth the effort? Crit Care Med. 2010 Jun;38(6):1484-5. doi: 10.1097/CCM.0b013e3181e08fff. No abstract available.
PubMed 20502139
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic and Cardiac Effects of Individualized PEEP Titration Using Esophageal Pressure Measurements in ARDS Patients
- ClinicalTrials.gov ID
- NCT02617914
- Acronym / sponsor ID
- ENCODE / 15-122
- Conditions
- Severe Acute Respiratory Distress Syndrome / Severe ARDS, Invasive Mechanical Ventilation, Individualized PEEP Treatment Strategy
- Keywords
- ARDS, PEEP, ECMO
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No approval from EC obtained. More details for study were required by EC.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 1 Dec 2015 (estimated)
- 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.
The acute respiratory distress syndrome (ARDS) is common condition in critical ill patients affecting 7.2 people / 100,000 population / year and more than 7% of patients with invasive mechanical ventilation for more than 24 hours. ARDS carries a high hospital mortality of up to 48% and consumes large amounts of critical care resources. ARDS patients often present with severe hypoxemia that is refractory to conventional treatment and are thus evaluated for extracorporeal membrane oxygenation (ECMO). However, uncertainty regarding the appropriate indication for ECMO and clinical evidence for ECMO as a rescue treatment are still controversial. In 2012 Grasso and colleagues therefore presented a case series of influenza A (H1N1) ARDS patients describing the use of esophageal pressure measurements for individualized PEEP titration to achieve an end expiratory plateau pressure of the lung (PPLATL) of 25cm H2O. After performing the measurements in 14 patients, ventilator settings could be adjusted in half of these patients by increasing PEEP which resulted in an increase of oxygenation measures to an extend that criteria for extracorporeal support where no longer met and conventional treatment with invasive mechanical ventilation could be continued. However, uncertainty remains as to whether these results are generalizable to ARDS of any cause. In addition, increasing PEEP might impact on cardiac function and might therefore be associated with clinical important hemodynamic effects in these patients.
The investigators aim to evaluate hemodynamic changes in patients with severe ARDS in which an individualized PEEP treatment strategy can be employed. ARDS will be defined and stratified according to the Berlin ARDS definition. A naso-gastric probe capable of measuring esophageal pressure will be inserted directly after admission to the ICU as previously described. Invasive mechanical ventilation and oesophageal pressure measurements will be done using the GE Healthcare Carescape R860 ventilator. A pulmonary artery catheters (Edwards CCOcomb) will be inserted to evaluate the hemodynamic parameters of cardiac output, pulmonary artery pressures and left atrial pressures. Volumetric parameters will be measured using tanspulmonary thermodilution devices (Edwards EV1000). Cardiac function will be addressed in addition by the use of a predefined echocardiography protocol.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients referred to our ICU (Criitical Care Unit) for treatment of ARDS of any cause with a P/F ratio < 150 and indication for continued maximum critical care therapy. Patients of childbearing age with ARDS will be included.
Key inclusion criteria (4 listed)
- Patients referred to our ICU for treatment of ARDS of any cause with a P/F ratio < 150 and indication for continued maximum critical care therapy
- Male or female aged > 18 years
- Written informed consent prior to study participation
- The subject is willing and able to follow the procedures outlined in the protocol
Key exclusion criteria (5 listed)
- Patients admitted for primarily left ventricular or biventricular heart failure who are exclusively in need of cardiac and not pulmonary mechanical assist
- Pregnant and lactating females
- Patient has been committed to an institution by legal or regulatory order
- Participation in a parallel interventional clinical trial
- The subject received an investigational drug within 30 days prior to inclusion into this study
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 |
|---|---|---|
| individualized PEEP treatment, Invasive mechanical ventilation, ECMO, | Procedure or surgery | – |
Primary outcome
Hemodynamic changes in parameters of cardiac output
Time frame: Within the first 6 hours after ICU admission
Hemodynamic changes in parameters of pulmonary artery pressure
Time frame: Within the first 6 hours after ICU admission
Hemodynamic changes in parameters of left atrial pressures
Time frame: Within the first 6 hours after ICU admission
Hemodynamic changes in volumetric parameters
Time frame: Within the first 6 hours after ICU admission
5 secondary outcomes
ICU length of stay
Time frame: Within 28 days after ICU admission
Time of ventilator
Time frame: Within 28 days after ICU admission
Necessity of ECMO support
Time frame: Within 28 days after ICU admission
Hospital length of stay
Time frame: Within 28 days after ICU admission
28-day mortality
Time frame: Within 28 days after ICU admission
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Background: PubMed 21997128Villar J, Blanco J, Anon JM, Santos-Bouza A, Blanch L, Ambros A, Gandia F, Carriedo D, Mosteiro F, Basaldua S, Fernandez RL, Kacmarek RM; ALIEN Network. The ALIEN study: incidence and outcome of acute respiratory distress syndrome in the era of lung protective ventilation. Intensive Care Med. 2011 Dec;37(12):1932-41. doi: 10.1007/s00134-011-2380-4. Epub 2011 Oct 14.
- Background: PubMed 22926653Ferguson ND, Fan E, Camporota L, Antonelli M, Anzueto A, Beale R, Brochard L, Brower R, Esteban A, Gattinoni L, Rhodes A, Slutsky AS, Vincent JL, Rubenfeld GD, Thompson BT, Ranieri VM. The Berlin definition of ARDS: an expanded rationale, justification, and supplementary material. Intensive Care Med. 2012 Oct;38(10):1573-82. doi: 10.1007/s00134-012-2682-1. Epub 2012 Aug 25.
- Background: PubMed 20721530Roch A, Lepaul-Ercole R, Grisoli D, Bessereau J, Brissy O, Castanier M, Dizier S, Forel JM, Guervilly C, Gariboldi V, Collart F, Michelet P, Perrin G, Charrel R, Papazian L. Extracorporeal membrane oxygenation for severe influenza A (H1N1) acute respiratory distress syndrome: a prospective observational comparative study. Intensive Care Med. 2010 Nov;36(11):1899-905. doi: 10.1007/s00134-010-2021-3. Epub 2010 Aug 19.
- Background: PubMed 21976615Noah MA, Peek GJ, Finney SJ, Griffiths MJ, Harrison DA, Grieve R, Sadique MZ, Sekhon JS, McAuley DF, Firmin RK, Harvey C, Cordingley JJ, Price S, Vuylsteke A, Jenkins DP, Noble DW, Bloomfield R, Walsh TS, Perkins GD, Menon D, Taylor BL, Rowan KM. Referral to an extracorporeal membrane oxygenation center and mortality among patients with severe 2009 influenza A(H1N1). JAMA. 2011 Oct 19;306(15):1659-68. doi: 10.1001/jama.2011.1471. Epub 2011 Oct 5.
- Background: PubMed 20371522Hubmayr RD, Farmer JC. Should we "rescue" patients with 2009 influenza A(H1N1) and lung injury from conventional mechanical ventilation? Chest. 2010 Apr;137(4):745-7. doi: 10.1378/chest.09-2915. No abstract available.
- Background: PubMed 20400902Mitchell MD, Mikkelsen ME, Umscheid CA, Lee I, Fuchs BD, Halpern SD. A systematic review to inform institutional decisions about the use of extracorporeal membrane oxygenation during the H1N1 influenza pandemic. Crit Care Med. 2010 Jun;38(6):1398-404. doi: 10.1097/CCM.0b013e3181de45db.
- Background: PubMed 22323077Grasso S, Terragni P, Birocco A, Urbino R, Del Sorbo L, Filippini C, Mascia L, Pesenti A, Zangrillo A, Gattinoni L, Ranieri VM. ECMO criteria for influenza A (H1N1)-associated ARDS: role of transpulmonary pressure. Intensive Care Med. 2012 Mar;38(3):395-403. doi: 10.1007/s00134-012-2490-7. Epub 2012 Feb 10.
- Background: PubMed 24467647Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.
- Background: PubMed 20502139Dalton HJ, MacLaren G. Extracorporeal membrane oxygenation in pandemic flu: insufficient evidence or worth the effort? Crit Care Med. 2010 Jun;38(6):1484-5. doi: 10.1097/CCM.0b013e3181e08fff. No abstract available.
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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.
Alexander Kersten, MD principal investigator
Department of Cardiology, Pneumology, Vascular Medicine and Critical Care (Medical Clinic I), University Hospital Aachen, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Acute Respiratory Distress Syndrome / Severe ARDS and Invasive Mechanical Ventilation, run by RWTH Aachen University.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Hemodynamic changes in parameters of cardiac output (time frame: Within the first 6 hours after ICU admission). The study lists 4 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 NCT02617914, which also lists 9 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 25 Apr 2017.