# Novel Pediatric Endotracheal Tube Securement System

> **NIH NIH R44** · MINNESOTA HEALTHSOLUTIONS CORPORATION · 2022 · $748,249

## Abstract

Project Summary/Abstract
Minnesota HealthSolutions Corporation and Children’s Hospital Los Angeles propose to develop a novel
pediatric/neonatal endotracheal tube securement system with the aim of reducing unplanned extubation and
associated complication rates. Mechanical ventilation through an endotracheal tube is routine in pediatric and
neonatal intensive care units and has contributed to improved survival and reduced morbidity. However,
unplanned extubations are unfortunately common, and are associated with hemodynamic instability, hypoxia,
hypercarbia, airway trauma, ventilator associated pneumonia, intraventricular hemorrhage, and death.
Neonates, infants and children have unique challenges with endotracheal tube securement and pediatric
patients are at particularly high risk for unplanned extubation due to anatomic and physiologic factors. There
exists great enthusiasm for improved devices or methods for safely maintaining pediatric endotracheal tubes.
The proposed project explores a novel securement system with several innovative features. The objective of
this proposed fast-track project is to develop and evaluate a neonatal/pediatric securement system that
leverages a novel interlocking stabilizer concept which is used in an FDA cleared adult endotracheal tube
securement system. While building off the adult system, key elements of innovation unique to the pediatric
system include an adjustable stabilizer design where the interlocking securement mechanism is locked directly
onto any FDA approved ET tube and adjustably fits into a corresponding ribbed receiver on a stabilizer with an
easy-to-use locking system. The innovative stabilizer is integrated into comfortable, non-skin-irritating retention
structures specifically designed to fit pediatric patients, including pre-term neonates. Several initial pediatric
prototypes have undergone extensive, iterative feedback from over 25 respiratory therapists, neonatologists,
and intensive care physicians and nurses. This has resulted in mature designs of three securement devices to
span the range from preterm neonates to children. The objective of phase I is to finalize the design and
manufacture the 3 different sized pediatric prototypes and evaluate their: 1) feedback to inform design,
workflow and usability refinements in focus groups and 2) ability to resist pull events in a bench-top model.
The objective of phase II is to advance the prototype design to a finished production product, conduct
performance bench testing to demonstrate safety and efficacy, and evaluate manufactured units in a phase II
randomized controlled trial.

## Key facts

- **NIH application ID:** 10656945
- **Project number:** 4R44HD103566-02
- **Recipient organization:** MINNESOTA HEALTHSOLUTIONS CORPORATION
- **Principal Investigator:** Nick Rydberg
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $748,249
- **Award type:** 4N
- **Project period:** 2022-08-01 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10656945

## Citation

> US National Institutes of Health, RePORTER application 10656945, Novel Pediatric Endotracheal Tube Securement System (4R44HD103566-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10656945. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*