Lower Limb Surveillance During VA-ECLS

Lower Limb Surveillance During VA-ECLS: Evaluation of Angiography Through the Reperfusion Cannula at VA-ECMO Implantation and of Near Infrared Spectroscopy (NIRS) Monitoring

Temporary cardiac support by VA-ECLS can lead to lower limb ischemia. The aim of this study is to evaluate a multi-modal strategy (physical examination, NIRS monitoring and angiography through the reperfusion canula) of lower limb surveillance.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest; Cardiogenic Shock; Lower Limb Ischemia
• Intervention / Treatment: Procedure: Lower limb angiography via the reperfusion cannula and NIRS monitoring

Detailed Description

VA ECLS is used as a temporary circulatory support during cardiogenic shock and refractory cardiac arrest. Complications of VA ECLS include hemorrhagic, infectious and ischemic events. VA ECLS requires arterial and venous canules which are frequently positioned in the femoral artery and vein, which carries the risk of lower limb ischemia due to retrograde flow and obstruction of the femoral artery lumen. VA ischemia during VA ECLS is frequent (11-52%) and requires the use of reperfusion canula in the femoral common artery on VA ECLS implantation in a primary prevention strategy, before lower limb ischemia occurs. Even with this strategy, lower limb ischemia can occur due to arterial thrombosis, arterial spasm or insufficient blood flow through the reperfusion canula. Lower limb complications are prevented by monitoring of regional oxygen saturation, control of the reperfusion canula position (ultrasound, angiography) and rapid management when lower limb ischemia is suspected. There are no clear recommendations regarding prevention of lower limb complications during VA ECLS and arterial angiography has been described to diagnose ischemic events and evaluate the effectiveness of an intervention such as injection of vasodilators. This study is a prospective evaluation of a strategy to prevent lower limb complications during VA ECLS with a systematic arterial angiography on VA ECLS implantation and when lower limb ischemia is suspected (regional oxygen tissue saturation <50% or a differential >15% between both lower limbs) in addition to continuous NIRS monitoring of lower limbs during VA ECLS.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • Nancy, France
    • Chu de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients under Temporary Cardiac Support with VA-ECLS

Description

Inclusion Criteria:

• Temporary circulatory support with VA ECLS
• Age > 18 years

Exclusion Criteria:

• Pregnancy
• History of iodinated contrast allergy
• History of lower limb amputation above the ankle
• Lower limb ischemia before starting of VA-ECLS
• Femoro-axillary VA-ECLS
• Absence of the lower limb reperfusion canula

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VA ECMO; Patients under VA-ECMO with a femoral reperfusion cannula.	Procedure: Lower limb angiography via the reperfusion cannula and NIRS monitoring; Data collection only (lower limb angiography, lower limbs NIRS values).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe limb ischemia	Ischemia leading to surgical intervention, functional sequelae, necrosis of the extremities or compartment syndrome	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality rate	28 days and 60 days
Incidence of ischemia of the lower limb during ICU stay	StO2 < 50% during 4 consecutive minutes AND/OR StO2 differential > 15% during ICU stay	2 months
Incidence of renal replacement therapy during ICU stay	Number of patients who underwent renal replacement therapy	2 months
Duration of ICU stay	Number of days in the ICU	60 days
Duration of hospital stay	Number of days in the hospital	60 days

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Matthieu Koszutski, Dr, Chu de Nancy

Publications and helpful links

General Publications

• Koszutski M, Mattei M, Maureira JP, Kimmoun A, Levy B. Assessment of bedside lower limb angiography combined with continuous NIRS monitoring for the detection of lower limb complications of VA-ECMO: an observational monocentric study. Crit Care. 2021 Jul 31;25(1):270. doi: 10.1186/s13054-021-03703-5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): June 1, 2020

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (ACTUAL): April 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: VA-ECMO; VA-ECLS; Near-Infrared Spectroscopy (NIRS)
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Shock; Myocardial Infarction; Infarction; Ischemia; Shock, Cardiogenic
• Other Study ID Numbers: PSS2018/MIRECMO-KOSZUTSKI/YB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No