Impact of Cannulation Strategy on Neurologic Injury in Infants With Respiratory Failure

Impact of Cannulation Strategy on the Rate of Neurologic Injury in Infants With Respiratory Failure: A Propensity Score Analysis of the ELSO Registry

There has been increasing use of venoarterial (VA) extracorporeal membrane oxygenation (ECMO) for infants with respiratory failure, up to 92% of neonatal respiratory support in 2021. This study seeks to leverage the increased use of VA ECMO in this cohort to enrich an evaluation of the differences in rate of intracranial hemorrhage and ischemic stroke between venovenous (VV) and VA ECMO among infants with respiratory failure where clinicians may choose either strategy.

This project is a retrospective review of data in the ELSO registry.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Procedure: Venovenous ECMO; Procedure: Venoarterial ECMO

Detailed Description

From 2019-2021, there was increased use of venoarterial (VA) extracorporeal membrane oxygenation (ECMO) for infants with respiratory failure, up to 92% of neonatal respiratory support in 2021. The primary aim is to estimate the average effect on the rate of neurologic injury of VA ECMO versus venovenous (VV) among infants with respiratory failure over the period 2013-2018, during which clinicians could choose either cannulation strategy. This causal effect will be estimated using an inverse propensity weighted (IPW) approach. Secondarily, the investigators will project this estimated treatment effect forward into the period 2019-2021. The beginning of this period roughly corresponds to start of increased use of VA ECMO. Under the assumption of a homogenous treatment effect across both study periods, the rate of neurologic injury that would have occurred in 2019-2021 will be estimated, had the rate of VA ECMO not increased relative to pre-2019 levels. The hypothesis is that the results will point to an increased rate of neurologic injury starting in 2019 due to the increased use of VA ECMO.

• Study Type: Observational
• Enrollment (Actual): 5058

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients reported to the ELSO registry weighing less than or equal to 10 kilograms at the start of ECMO receiving ECMO for pulmonary support

Description

Inclusion Criteria:

• Patient weighed less than or equal to 10kg at start of ECMO
• Pulmonary support was the indication for ECLS
• Initial cannulation strategy was VV or VA
• The run occurred during the period 2013-2023

Exclusion Criteria:

• Patient had CDH
• Patient was post-cardiotomy

• Non-conventional initial cannulation strategies were employed, such as

  • Central Cannulation (surrogate for inability to achieve peripheral cannulation)
  • Veno-veno-arterial ECMO
  • Initial cannulation approach reported as "other"
• Patient was transported into or out of ELSO center on ECMO support
• Patient had pre-ECLS Cardiac Arrest
• Patient did not have subsequent ECMO runs in the ELSO registry

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Venovenous ECMO	Procedure: Venovenous ECMO; Initial support type of venovenous ECMO via a dual-lumen on two-site VV ECMO cannulation strategy
Venoarterial ECMO	Procedure: Venoarterial ECMO; Initial support type of venoarterial ECMO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurologic Injury	The outcome will be the composite occurrence of neurologic injury (ischemic stroke, intracranial hemorrhage, and brain death) that arises during critical illness supported by extracorporeal life support (ECLS) as reported to the Extracorporeal Life Support Organization (ELSO) registry, coded as a 0/1 variable (0 = no occurrence was reported during or after ECMO; 1 = one or more occurrence was reported).	during critical illness supported by ECLS up to 14 days after ECLS stop time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Whether a patient is discharged alive as reported to the ELSO registry	through study completion (ECLS hospital discharge), an average of 2 months
Duration of ECMO support	Hours of ECMO support as reported to the ELSO registry	during the procedure (ECLS support)
Discharge Disposition	Hospital discharge location as reported to the ELSO registry	through study completion (ECLS hospital discharge), an average of 2 months
Individual neurologic injury	For each neurologic injury included in the primary outcome measure, the injury will be assessed individually: proportion of patients with ischemic stroke as defined by the ELSO registry; proportion of patients with intracranial hemorrhage as defined by the ELSO registry; proportion of patients with brain death as defined by the ELSO registry	during the procedure (ECLS support), and up to 14 days days after ECLS stop time

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Joseph G Kohne, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Actual): December 12, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: ECMO
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: HUM00236110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data received from the ELSO Registry is available to qualified researchers through an ELSO data request

Drug and device information, study documents

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