- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03041428
Ultra Protective Ventilation During Venoarterial Extracorporeal Membrane Oxygenation (UPV-ECMO) (UPV-ECMO)
March 29, 2021 updated by: Fundación para la Investigación Biosanitaria del Principado de Asturias
Effect of Ultraprotective Ventilation on the Lung Inflammatory Response in Patients With Acute Pulmonary Edema Treated With Venoarterial Extracorporeal Oxygenation
Mechanical ventilation, in spite of being a life-saving technique, can also induce lung injury (VILI) mediated by an inflammatory response, thus having a profound impact in the course of critically ill patients.
Ventilatory strategies aimed to minimize this VILI have reduced mortality rates.
Patients suffering cardiogenic pulmonary edema may need venoarterial extracorporeal oxygenation, at the same time they are being mechanically ventilated.
The objective of this study is to analyze changes induced by the use of utraprotective ventilatory strategies in the inflammatory lung response of these patients and their impact on outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Mechanical ventilation is the cornerstone of the critically-ill patients support, providing better gas exchange conditions while respiratory muscles rest.
Providing this life-support technique may be harmful on the lung tissue, last decades research efforts were focused on minimizing the ventilator-induced lung injury (VILI).
Knowledge regarding the mechanisms of this injury has led to changes in the clinical practice, consisting on the application of positive end-expiratory pressure (PEEP) and the use of low tidal volumes, giving rise to the strategy known as "protective ventilation".
Moreover, the use of extracorporeal membrane oxygenation (ECMO) techniques contributes to maintaining an adequate gas exchange until lung damage resolution.
A tidal volume in the range of 6 ml/Kg of ideal body weight, with a reasonable level of PEEP is the standard of care for patients with the ARDS.
However, optimal levels of tidal volume and PEEP have not been completely established.
On the other side, decreasing tidal volume below 6 ml/Kg faces its own problems.
The role of the so-called "ultraprotective" approaches, in which extracorporeal support is required to reduce tidal volumes up to 3 ml/kg or less, although feasible, is currently under research.
During venoarterial ECMO, blood is removed from the vessels and pumped through a circuit where is oxygenated and CO2 is removed; finally, the blood is returned to the arterial circulation.
The development of new circuits and devices made this therapy become safer and more useful, improving outcomes so that its application has been widespread to many centers all over the world.
One of the ECMO advantages is carbon dioxide removal, which allows reducing tidal volume below 6 ml/kg.
Ultraprotective strategies with 3 ml/kg have demonstrated to be feasible, but the additional benefit of this strategy is to be demonstrated.
Therefore, in this study, patients suffering cardiogenic pulmonary edema requiring ECMO and mechanical ventilation are submitted to an ultraprotective ventilator strategy.
Lung inflammatory response is measured before and after the intervention, in order to evaluate its impact in this subset of patients.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Principado De Asturias
-
Oviedo, Principado De Asturias, Spain, 33011
- Hospital Universitario Central de Asturias (HUCA)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cardiogenic pulmonary edema supported by venoarterial extracorporeal membrane oxygenation.
- Invasive mechanical ventilatory support under sedation.
Exclusion Criteria:
- Immunosupresion.
- Hemodynamic instability refractory to mechanical support, conditioning an end-of-life approach and terminal situation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Recruited patients
Ultraprotective ventilation
|
Adjusting ventilator parameters for 3 ml/kg of tidal volume in order to achieve the ultra protective strategy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in lung inflammatory mediators levels
Time Frame: Baseline and 18 hours after the intervention
|
Bronchoalveolar lavage cytokines levels, measured in ng/ml
|
Baseline and 18 hours after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Guillermo M Albaiceta, HUCA-FINBA, Universidad de Oviedo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. doi: 10.1164/rccm.200607-915OC. Epub 2006 Oct 12.
- Bein T, Weber-Carstens S, Goldmann A, Muller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS. Lower tidal volume strategy ( approximately 3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013 May;39(5):847-56. doi: 10.1007/s00134-012-2787-6. Epub 2013 Jan 10.
- Fan E, Gattinoni L, Combes A, Schmidt M, Peek G, Brodie D, Muller T, Morelli A, Ranieri VM, Pesenti A, Brochard L, Hodgson C, Van Kiersbilck C, Roch A, Quintel M, Papazian L. Venovenous extracorporeal membrane oxygenation for acute respiratory failure : A clinical review from an international group of experts. Intensive Care Med. 2016 May;42(5):712-724. doi: 10.1007/s00134-016-4314-7. Epub 2016 Mar 23.
- Acute 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.
- Figueroa-Casas JB, Montoya R. Effect of Tidal Volume Size and Its Delivery Mode on Patient-Ventilator Dyssynchrony. Ann Am Thorac Soc. 2016 Dec;13(12):2207-2214. doi: 10.1513/AnnalsATS.201605-362OC.
- Determann RM, Royakkers A, Wolthuis EK, Vlaar AP, Choi G, Paulus F, Hofstra JJ, de Graaff MJ, Korevaar JC, Schultz MJ. Ventilation with lower tidal volumes as compared with conventional tidal volumes for patients without acute lung injury: a preventive randomized controlled trial. Crit Care. 2010;14(1):R1. doi: 10.1186/cc8230. Epub 2010 Jan 7.
- Leligdowicz A, Fan E. Extracorporeal life support for severe acute respiratory distress syndrome. Curr Opin Crit Care. 2015 Feb;21(1):13-9. doi: 10.1097/MCC.0000000000000170.
- Schmidt M, Stewart C, Bailey M, Nieszkowska A, Kelly J, Murphy L, Pilcher D, Cooper DJ, Scheinkestel C, Pellegrino V, Forrest P, Combes A, Hodgson C. Mechanical ventilation management during extracorporeal membrane oxygenation for acute respiratory distress syndrome: a retrospective international multicenter study. Crit Care Med. 2015 Mar;43(3):654-64. doi: 10.1097/CCM.0000000000000753.
- Amado-Rodriguez L, Del Busto C, Lopez-Alonso I, Parra D, Mayordomo-Colunga J, Arias-Guillen M, Albillos-Almaraz R, Martin-Vicente P, Lopez-Martinez C, Huidobro C, Camporota L, Slutsky AS, Albaiceta GM. Biotrauma during ultra-low tidal volume ventilation and venoarterial extracorporeal membrane oxygenation in cardiogenic shock: a randomized crossover clinical trial. Ann Intensive Care. 2021 Aug 28;11(1):132. doi: 10.1186/s13613-021-00919-0.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
March 1, 2021
Study Registration Dates
First Submitted
February 1, 2017
First Submitted That Met QC Criteria
February 1, 2017
First Posted (Estimate)
February 2, 2017
Study Record Updates
Last Update Posted (Actual)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 29, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FINBA_CritLab_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All datasets underlying the study are available upon request to the study principal investigators.
All of the individual participant data collected during the trial, informed consent forms, study protocol, statistical analysis plan, analytic R code and raw data, are available under reasonable request, and after deindentification.
IPD Sharing Time Frame
Starting 3 months after publication.
IPD Sharing Access Criteria
Principal investigators will review requests of data to be provided.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ventilator-Induced Lung Injury
-
Capital Medical UniversityBeijing Tiantan HospitalCompleted
-
Ayse UlgeyNot yet recruitingVentilator-induced Lung InjuryTurkey
-
Lungpacer Medical Inc.CompletedVentilator Induced Lung InjuryParaguay
-
Lingling DingNot yet recruitingElectroacupuncture | Lung Injury, Ventilator Induced
-
Shanghai Zhongshan HospitalUnknownMechanical Ventilation | Transpulmonary Pressure | Ventilator-induced Lung InjuryChina
-
Kocaeli UniversityCompletedVentilator-Induced Lung Injury | Ventilator Adverse Event | Lung Injury, AcuteTurkey
-
Gazi UniversityCompletedVentilator Induced Lung Injury | Respiratory Distress, NewbornTurkey
-
E-DA HospitalCompletedVentilator-Induced Lung Injury | One-lung Ventilation | Lung VentilatorTaiwan
-
University of Sao PauloInCor Heart InstituteCompletedAcute Lung Injury | Cardiac Disease | Ventilator Induced Lung InjuryBrazil
-
University Hospital OstravaRecruitingARDS | Lung Injury, Ventilator InducedCzechia
Clinical Trials on Ultraprotective ventilation
-
Hospices Civils de LyonRecruitingPneumonia | Acute Respiratory Distress Syndrome | COVID19 | Sars-CoV2France
-
University of BolognaGetinge GroupNot yet recruitingAcute Respiratory Distress Syndrome
-
University of AarhusCompletedSleep | Environmental Exposure | Cognitive Impairment, MildDenmark
-
Xuzhou Medical UniversityUnknownInflammation | Thoracic Surgery | Pulmonary ComplicationChina
-
Shanghai Ninth People's Hospital Affiliated to...Unknown
-
Shanghai Zhongshan HospitalCompleted
-
Fundació Institut de Recerca de l'Hospital de la...WithdrawnObesity Hypoventilation Syndrome (OHS) | Chest Wall Disorders | Neuromuscular DisordersSpain
-
National Taiwan University HospitalRecruiting
-
Joseph D. TobiasCompleted
-
Boston Medical CenterWallace H. Coulter FoundationTerminated