Personalized Ventilator Settings for Patients on ECMO (PEEPECMO)
Personalized Ventilator Settings for Patients on ECMO (PEEPECMO)
While mechanical ventilation can be used to sustain life in those with lung injury, it, can further worsen lung injury or prevent lung healing resulting in high morbidity and mortality as seen in Acute Respiratory Distress Syndrome (ARDS).
Using extracorporeal membrane oxygenation (ECMO), the highest level of life support also known as the heart-lung machine, investigators may minimize injury from mechanical ventilation to allow the lungs to heal; however, the optimal ventilator strategies while on ECMO are unknown. This study will evaluate personalized ventilator strategy compared to standard of care ventilation.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
While mechanical ventilation can be used to sustain life in those with severe ARDS, it, can further worsen lung injury or prevent lung healing resulting in high morbidity and mortality. Using ECMO, investigators may be able to minimize injury from mechanical ventilation to allow the lungs to to recover from ARDS; however, the optimal ventilator settings and therapies are unknown while on ECMO. This trial will randomize patients to personalized ventilator strategy vs. standard of care.
Current ventilator guidelines while on V-V ECMO for ARDS use a one-size-fits-all approach - respiratory rate 10, driving pressure 10, and a PEEP of 10. Our central hypothesis is that personalized PEEP adjusted by measuring intrathoracic pressures via esophageal manometry (Pes) will decease ventilator induced lung injury (VILI) as assessed by biomarkers of inflammation (main outcomes IL-6 and sRAGE).
To carry out these aims, participants with ARDS on V-V ECMO will be prospectively randomize patients to two groups:
Control Arm: PEEP of 10 cmH2O (ECMO guidelines). Intervention Arm: PEEP guided by esophageal manometry. Both arms will have be on neuromuscular blockade, with a respiratory rate set at 10 breaths/min and a driving pressure of 10 cmH2O.
In addition to biomarkers of VILI, investigators will assess differences in other physiological outcomes including pulmonary mechanics and gas exchange.
Hypothesis: Personalized PEEP will have improvement in biomarkers (primary outcome - IL-6 and sRAGE), oxygenation, decreased dead space, and respiratory mechanics.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Mazen F Odish, M.D.
- Telefonnummer: 858-657-7023
- E-mail: modish@health.ucsd.edu
Undersøgelse Kontakt Backup
- Navn: Robert L Owens, M.D.
- Telefonnummer: 858-657-5258
- E-mail: rowens@health.ucsd.edu
Studiesteder
-
-
California
-
La Jolla, California, Forenede Stater, 92037
- UC San Diego Health Jacobs Medical Center
-
Kontakt:
- Mazen F Odish, M.D.
- Telefonnummer: 8586577023
- E-mail: modish@health.ucsd.edu
-
Kontakt:
- Robert L Owens, M.D.
- E-mail: rowens@health.ucsd.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
- History of Lung or Cardiac Transplantation, or definite bridge to transplantation
- Patient is not committed to full support
- Treating clinician refusal, or unwillingness to commit to controlled therapeutics (Esophageal Pressure Guided Positive End-Expiratory Pressure and neuromuscular blockade)
- Inability to get informed consent from the patient or legally authorized representative (LAR)
Patients with contraindications to esophageal balloon placement or inability to successfully place an esophageal balloon will have personalized PEEP determined by electrical impedance tomography.
a. Contraindications include recently treated or bleeding varices, esophageal stricture, hematemesis, esophageal trauma, recent esophageal surgery or other contraindication for nasogastric tube placement, or severe coagulopathy.
- Severe barotrauma that requires lower mean airway pressure (i.e., PEEP) per the treating physician.
- Patients who are pregnant or prisoners.
- Has been on V-V ECMO > 72 hours.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Standard of Care Ventilator Settings while on ECMO
Classic ventilator settings for patients on ECMO.
Pressure control, with a respiratory rate of 10, driving pressure of 10, and PEEP of 10.
|
|
|
Eksperimentel: Personalized PEEP
Classic ventilator settings for patients on ECMO.
Pressure control, with a respiratory rate of 10, driving pressure of 10, and a personalized PEEP (intervention)
|
The personalized Positive End-Expiratory Pressure (PEEP) will be determined by esophageal manometry or electrical impedance tomography (EIT)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Biomarker outcomes (IL-6 and sRAGE)
Tidsramme: Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment, 72±12 hours post enrollment, and end of ECMO run.
|
IL-6 is a marker of systemic inflammation, previously used in studies of ECMO and ARDS. sRAGE is a marker of systemic inflammation and acute lung injury, previously used in studies of ECMO and ARDS. |
Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment, 72±12 hours post enrollment, and end of ECMO run.
|
|
Respiratory gas exchange (dead space, oxygenation).
Tidsramme: Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment, 72±12 hours post enrollment.
|
Arterial oxygenation (mmHg) will be assessed with the arterial blood gas.
Deadspace fraction (unitless) will be calculated by the end-title CO2 monitoring.
|
Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment, 72±12 hours post enrollment.
|
|
Respiratory mechanics (compliance of the respiratory system, tidal volume, and imaging)
Tidsramme: Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment, and 72±12 hours post enrollment.
|
Compliance (ml/cmH2O) and tidal volumes (milliliters) will be measured by the ventilator.
Imaging assessed will be the daily chest x-ray.
|
Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment, and 72±12 hours post enrollment.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Exploratory plasma, urine, and respiratory biomarkers.
Tidsramme: Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment, 72±12 hours post enrollment, and end of ECMO run.
|
Exploratory plasma biomarkers include but are not limited to: angiopoietin-1, angiopoietin-2; chemokind ligand-9, interferon-α; interferon γ-inducible protein-10, tumor necrosis factor α, vascular endothelial growth factor levels, etc.
|
Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment, 72±12 hours post enrollment, and end of ECMO run.
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mazen F Odish, M.D., University of California, San Diego
Publikationer og nyttige links
Generelle publikationer
- Combes A, Hajage D, Capellier G, Demoule A, Lavoue S, Guervilly C, Da Silva D, Zafrani L, Tirot P, Veber B, Maury E, Levy B, Cohen Y, Richard C, Kalfon P, Bouadma L, Mehdaoui H, Beduneau G, Lebreton G, Brochard L, Ferguson ND, Fan E, Slutsky AS, Brodie D, Mercat A; EOLIA Trial Group, REVA, and ECMONet. Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome. N Engl J Med. 2018 May 24;378(21):1965-1975. doi: 10.1056/NEJMoa1800385.
- Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
- Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.
- Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.
- Brodie D, Slutsky AS, Combes A. Extracorporeal Life Support for Adults With Respiratory Failure and Related Indications: A Review. JAMA. 2019 Aug 13;322(6):557-568. doi: 10.1001/jama.2019.9302.
- Dianti J, Tisminetzky M, Ferreyro BL, Englesakis M, Del Sorbo L, Sud S, Talmor D, Ball L, Meade M, Hodgson C, Beitler JR, Sahetya S, Nichol A, Fan E, Rochwerg B, Brochard L, Slutsky AS, Ferguson ND, Serpa Neto A, Adhikari NKJ, Angriman F, Goligher EC. Association of Positive End-Expiratory Pressure and Lung Recruitment Selection Strategies with Mortality in Acute Respiratory Distress Syndrome: A Systematic Review and Network Meta-analysis. Am J Respir Crit Care Med. 2022 Jun 1;205(11):1300-1310. doi: 10.1164/rccm.202108-1972OC.
- Schmidt M, Pham T, Arcadipane A, Agerstrand C, Ohshimo S, Pellegrino V, Vuylsteke A, Guervilly C, McGuinness S, Pierard S, Breeding J, Stewart C, Ching SSW, Camuso JM, Stephens RS, King B, Herr D, Schultz MJ, Neuville M, Zogheib E, Mira JP, Roze H, Pierrot M, Tobin A, Hodgson C, Chevret S, Brodie D, Combes A. Mechanical Ventilation Management during Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome. An International Multicenter Prospective Cohort. Am J Respir Crit Care Med. 2019 Oct 15;200(8):1002-1012. doi: 10.1164/rccm.201806-1094OC.
- Tonna JE, Abrams D, Brodie D, Greenwood JC, Rubio Mateo-Sidron JA, Usman A, Fan E. Management of Adult Patients Supported with Venovenous Extracorporeal Membrane Oxygenation (VV ECMO): Guideline from the Extracorporeal Life Support Organization (ELSO). ASAIO J. 2021 Jun 1;67(6):601-610. doi: 10.1097/MAT.0000000000001432.
- Lam MTY, Duttke SH, Odish MF, Le HD, Hansen EA, Nguyen CT, Trescott S, Kim R, Deota S, Chang MW, Patel A, Hepokoski M, Alotaibi M, Rolfsen M, Perofsky K, Warden AS, Foley J, Ramirez SI, Dan JM, Abbott RK, Crotty S, Crotty Alexander LE, Malhotra A, Panda S, Benner CW, Coufal NG. Dynamic activity in cis-regulatory elements of leukocytes identifies transcription factor activation and stratifies COVID-19 severity in ICU patients. Cell Rep Med. 2023 Feb 21;4(2):100935. doi: 10.1016/j.xcrm.2023.100935. Epub 2023 Jan 25.
- Odish MF, Yang J, Cheng G, Yi C, Golts E, Madani M, Pollema T, Owens RL. Treatment of Bronchopleural and Alveolopleural Fistulas in Acute Respiratory Distress Syndrome With Extracorporeal Membrane Oxygenation, a Case Series and Literature Review. Crit Care Explor. 2021 May 14;3(5):e0393. doi: 10.1097/CCE.0000000000000393. eCollection 2021 May.
- Odish M, Pollema T, Meier A, Hepokoski M, Yi C, Spragg R, Patel HH, Alexander LEC, Sun XS, Jain S, Simonson TS, Malhotra A, Owens RL. Very Low Driving-Pressure Ventilation in Patients With COVID-19 Acute Respiratory Distress Syndrome on Extracorporeal Membrane Oxygenation: A Physiologic Study. J Cardiothorac Vasc Anesth. 2023 Mar;37(3):423-431. doi: 10.1053/j.jvca.2022.11.033. Epub 2022 Nov 28.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sår og skader
- Luftvejsinfektioner
- Infektioner
- Orthomyxoviridae infektioner
- RNA-virusinfektioner
- Luftvejssygdomme
- Lungesygdomme
- Respirationsforstyrrelser
- Thoracale skader
- Influenza, menneske
- Respiratory Distress Syndrome
- Respiratorisk insufficiens
- Lungebetændelse
- Virussygdomme
- Lungeskade
- Ventilator-induceret lungeskade
Andre undersøgelses-id-numre
- 805593
- 1K23HL181397 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
The data will be archived at the NHLBI BioData Catalyst (biodatacatalyst.nhlbi.nih.gov), which is an NIH repository for heart, lung, blood, and sleep research.
Data will be made available for investigators subject to submission of a data access and subsequent approval by the BioData Catalyst. The approval will be contingent upon several factors, including verification of the investigator having valid scientific rationale and relevant institutional review board approval.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Ekstrakorporal membraniltning
-
Institute for Extracorporeal Life SupportTilmelding efter invitationRehabilitering | Hjerte-lungefunktion | ExtraCorporeal Membrane Oxygenation (ECMO)Forenede Stater
-
Central China Fuwai Hospital of Zhengzhou UniversityHenan Provincial People's Hospital; Union Hospital, Tongji Medical College...RekrutteringHjertestop | ExtraCorporeal Membrane Oxygenation (ECMO)Kina
-
University Hospital, GrenobleAfsluttetRefraktær hjertestop | ExtraCorporeal Membrane Oxygenation (ECMO)Frankrig
-
St. Antonius HospitalSt. Antonius Onderzoeksfonds; St. Antonius innovatiefondsIkke rekrutterer endnuSårkomplikationer | ExtraCorporeal Membrane Oxygenation (ECMO) | Kirurgisk infektion i operationsområdet (SSI)
-
Nantes University HospitalAfsluttet
-
IRCCS Policlinico S. MatteoAfsluttetEpimakulær membranItalien
-
Medical University of GrazAfsluttetEpiretinal membran af begge øjneØstrig
-
CHU de ReimsAfsluttetVitrektomi | Makulær udtyndingFrankrig
-
Centre Hospitalier Universitaire DijonAfsluttetHjertestop (CA) | ExtraCorporeal Life Support (ECLS)Frankrig
-
SMG-SNU Boramae Medical CenterAfsluttet
Kliniske forsøg med Personalized Positive End-Expiratory Pressure (PEEP)
-
Murdoch Childrens Research InstituteUniversity of Pennsylvania; University of Oxford; Academisch Medisch Centrum...Aktiv, ikke rekrutterendeFor tidlig fødsel | LungeskadeForenede Stater, Det Forenede Kongerige, Australien, Italien, Holland, Østrig, Frankrig
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)Aktiv, ikke rekrutterendeVentilator-induceret lungeskade | Sepsis syndrom | Mekanisk ventilationskomplikationForenede Stater
-
Riphah International UniversityIkke rekrutterer endnu
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)AfsluttetPostoperative lungekomplikationerForenede Stater