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

NCT ID: NCT06079034

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5058 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-18
• Study Completion Date: 2023-12-12

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.

Conditions

Respiratory Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Venovenous ECMO

Venovenous ECMO

Intervention Type: PROCEDURE

Initial support type of venovenous ECMO via a dual-lumen on two-site VV ECMO cannulation strategy

Venoarterial ECMO

Venoarterial ECMO

Intervention Type: PROCEDURE

Initial support type of venoarterial ECMO

Interventions

Venovenous ECMO

Initial support type of venovenous ECMO via a dual-lumen on two-site VV ECMO cannulation strategy

Intervention Type: PROCEDURE

Venoarterial ECMO

Initial support type of venoarterial ECMO

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 0 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Joseph Kohne (Pediatrics)

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph G Kohne

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

HUM00236110

Identifier Type: -

Identifier Source: org_study_id