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

NCT06079034 | Completed

• 1 other identifier: HUM00236110
• Study Type: observational
• Target: 5,058
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure

Keywords

ECMO

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mortality

  through study completion (ECLS hospital discharge), an average of 2 months

• Duration of ECMO support

  during the procedure (ECLS support)

• Discharge Disposition

  through study completion (ECLS hospital discharge), an average of 2 months

• Individual neurologic injury

  during the procedure (ECLS support), and up to 14 days days after ECLS stop time

Study Arms (2)

Venovenous ECMO

Procedure: Venovenous ECMO

Venoarterial ECMO

Procedure: Venoarterial ECMO

Interventions

Venovenous ECMO PROCEDURE

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

Venovenous ECMO

Venoarterial ECMO PROCEDURE

Initial support type of venoarterial ECMO

Venoarterial ECMO

Eligibility Criteria

• Age: 0 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Extracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Joseph G Kohne

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 12, 2023
• Study Start: October 18, 2023
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)