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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06079034
• Other study ID #: HUM00236110
• Status: Completed
• Start date: October 18, 2023
• Est. completion date: December 12, 2023

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5058
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• Venovenous ECMO
Initial support type of venovenous ECMO via a dual-lumen on two-site VV ECMO cannulation strategy
• Venoarterial ECMO
Initial support type of venoarterial ECMO

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	Whether a patient is discharged alive as reported to the ELSO registry	through study completion (ECLS hospital discharge), an average of 2 months
Secondary	Duration of ECMO support	Hours of ECMO support as reported to the ELSO registry	during the procedure (ECLS support)
Secondary	Discharge Disposition	Hospital discharge location as reported to the ELSO registry	through study completion (ECLS hospital discharge), an average of 2 months
Secondary	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