Blood Recirculation and vvECMO

ARDS Clinical Trial

Official title:

Measurment of Blood Recirculation and Adjustment of vvECMO Blood Flow During Veno-venous Extracoporeal Membrane Oxygenation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03200314
• Other study ID #: EA208317
• Status: Completed
• Start date: August 13, 2017
• Est. completion date: August 9, 2018

Study information

• Verified date: June 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A prospective, observational study will be performed measuring recirculation of blood through a veno-venous Extracoporeal Membrane Oxygenation (vvECMO) in patients with acute respiratory distress syndrome (ARDS) on vvECMO. ECMO blood flow will be adjusted with respect to recirculation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 9, 2018
• Est. primary completion date: August 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients aged 18 years or older

• ARDS

• veno-venous ECMO

Exclusion Criteria:

• age < 18 years

• hemodynamic instability during measurement of recirculation

• pregnancy

• inability to obtain patient's consent or consent of legal guardian

Related Conditions & MeSH terms

• ARDS
• Extracorporeal Membrane Oxygenation

Intervention

Other:
• Measurment of blood recirculation
Ultrasound based measurments of blood recirculating through the vvECMO circuit.

Locations

Country	Name	City	State
Germany	Charite University, Berlin, Germany	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recirculation of vvECMO blood flow	Amount of ECMO blood flow recirculating through the vvECMO circuit	Once within first week after ICU admission during 4 hours
Secondary	Reduction of vvECMO blood flow	Reduction of vvECMO blood flow if a significant recirculation can be measured	Once within first week after ICU admission during 4 hours
Secondary	Arterial blood oxygen content after reduction of vvECMO blood flow	Change in arterial blood oygen content after reduction of vvECMO blood flow	Once within first week after ICU admission during 4 hours