World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 April 2021
Main ID:  NCT03041428
Date of registration: 01/02/2017
Prospective Registration: Yes
Primary sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias
Public title: Ultra Protective Ventilation During Venoarterial Extracorporeal Membrane Oxygenation (UPV-ECMO) UPV-ECMO
Scientific title: Effect of Ultraprotective Ventilation on the Lung Inflammatory Response in Patients With Acute Pulmonary Edema Treated With Venoarterial Extracorporeal Oxygenation
Date of first enrolment: February 1, 2017
Target sample size: 20
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03041428
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Spain
Contacts
Name:     Guillermo M Albaiceta
Address: 
Telephone:
Email:
Affiliation:  HUCA-FINBA, Universidad de Oviedo
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Cardiogenic Pulmonary Edema
Ventilator-Induced Lung Injury
Extracorporeal Circulation; Complications
Intervention(s)
Device: Ultraprotective ventilation
Primary Outcome(s)
Change in lung inflammatory mediators levels [Time Frame: Baseline and 18 hours after the intervention]
Secondary Outcome(s)
Secondary ID(s)
FINBA_CritLab_1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history