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A Visual Tool for Central Line Consent: A Randomized Feasibility Trial.

Matthew C Spence^1,2, Jeffrey D Edwards¹

¹Division of Pediatric Critical Care and Hospital Medicine, Columbia University Irving Medical Center, New York-Presbyterian Morgan Stanley Children's Hospital, New York, New York.

Hospital Pediatrics

|February 5, 2026

Summary

This pilot study assessed a new visual tool for central venous access consent. While feasible and acceptable to parents, it did not significantly reduce anxiety or improve decisional comfort.

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Area of Science:

Pediatric Intensive Care
Clinical Trial Feasibility
Medical Device Evaluation

Background:

Procedural consent for central venous access in pediatric intensive care units (PICUs) can cause anxiety for surrogate decision-makers.
Assessing the impact of novel tools on parental anxiety and decisional comfort is crucial for improving the consent process.

Purpose of the Study:

To determine the feasibility of a clinical trial evaluating a novel central venous access visual tool.
To assess the tool's impact on surrogate decision-makers' anxiety and decisional comfort during procedural consent.

Main Methods:

A single-site, randomized pilot study involving parents of children requiring central venous access.
Parents were randomized to receive consent with or without the visual tool, with anxiety and decisional comfort measured using validated scales.
Feasibility was assessed by enrollment, retention, randomization, and parental acceptability.

Main Results:

Twenty-eight parents were enrolled and randomized, demonstrating good feasibility for enrollment and randomization.
Parents found the visual tool and study procedures highly acceptable.
No statistically significant differences were observed in parental state anxiety or decisional comfort between groups.

Conclusions:

The study demonstrated feasibility in terms of enrollment, retention, randomization, and parental acceptability for a clinical trial of a central venous access visual tool.
The tool did not show preliminary efficacy in decreasing parental anxiety or decisional discomfort.
Further research may be needed to refine the tool or explore its efficacy in different contexts.