COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH:
Working… Menu

Ultra Protective Ventilation During Venoarterial Extracorporeal Membrane Oxygenation (UPV-ECMO) (UPV-ECMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03041428
Recruitment Status : Active, not recruiting
First Posted : February 2, 2017
Last Update Posted : January 18, 2020
Information provided by (Responsible Party):
Fundación para la Investigación Biosanitaria del Principado de Asturias

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiogenic Pulmonary Edema Ventilator-Induced Lung Injury Extracorporeal Circulation; Complications Device: Ultraprotective ventilation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Ultraprotective Ventilation on the Lung Inflammatory Response in Patients With Acute Pulmonary Edema Treated With Venoarterial Extracorporeal Oxygenation
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Recruited patients
Ultraprotective ventilation
Device: Ultraprotective ventilation
Adjusting ventilator parameters for 3 ml/kg of tidal volume in order to achieve the ultra protective strategy

Primary Outcome Measures :
  1. Change in lung inflammatory mediators levels [ Time Frame: Baseline and 18 hours after the intervention ]
    Bronchoalveolar lavage cytokines levels, measured in ng/ml

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03041428

Layout table for location information
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Principado De Asturias, Spain, 33011
Sponsors and Collaborators
Fundación para la Investigación Biosanitaria del Principado de Asturias
Layout table for investigator information
Principal Investigator: Guillermo M Albaiceta HUCA-FINBA, Universidad de Oviedo

Layout table for additonal information
Responsible Party: Fundación para la Investigación Biosanitaria del Principado de Asturias Identifier: NCT03041428    
Other Study ID Numbers: FINBA_CritLab_1
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Injury
Pulmonary Edema
Ventilator-Induced Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries