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

Completed

• Conditions: Respiratory Failure
• Interventions: Procedure: Venoarterial ECMO; Procedure: Venovenous ECMO

• Registration Number: NCT06079034
• Lead Sponsor: University of Michigan

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-10-09
• Study First Posted: 2023-10-12
• Study Start: 2023-10-18
• Primary Completion: 2023-12-12
• Study Completion: 2023-12-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5058

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Venoarterial ECMO	Venoarterial ECMO	-
Venovenous ECMO	Venovenous ECMO	-

Primary Outcome Measures

Name	Time	Method
Neurologic Injury	during critical illness supported by ECLS up to 14 days after ECLS stop time	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).

Secondary Outcome Measures

Name	Time	Method
Mortality	through study completion (ECLS hospital discharge), an average of 2 months	Whether a patient is discharged alive as reported to the ELSO registry
Individual neurologic injury	during the procedure (ECLS support), and up to 14 days days after ECLS stop time	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
Discharge Disposition	through study completion (ECLS hospital discharge), an average of 2 months	Hospital discharge location as reported to the ELSO registry
Duration of ECMO support	during the procedure (ECLS support)	Hours of ECMO support as reported to the ELSO registry

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States