IntellO2 vs Manual Control for Optimizing Oxygenation in Infants

Overview

The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood oxygen saturation levels is safe and efficacious in the routine clinical environment. Specifically, it is hypothesized that the IntellO2 will perform as well or better than standard practice for maintaining infants' arterial blood oxygen saturation in a target range while minimizing the exposure to elevated levels of oxygen in the inspired gas.

Full Title of Study: “Comparison of the IntellO2 – Precision Flow Automatic FiO2 Controller to Manual Control for Optimizing Oxygenation in Preterm Infants Receiving High Flow Nasal Cannula Therapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2017

Interventions

  • Device: IntellO2
    • Automated FiO2 regulator that responds to pulse oximetry measures
  • Other: Manual control
    • Standard practice of manually titrating FiO2 as needed.

Arms, Groups and Cohorts

  • Experimental: IntellO2
    • Automated control of FiO2
  • Active Comparator: Manual
    • Manual control of FiO2

Clinical Trial Outcome Measures

Primary Measures

  • Percent time in target range for oxygen saturation by pulse oximetry
    • Time Frame: 24 hrs

Participating in This Clinical Trial

Inclusion Criteria

1. Preterm infants being treated with high flow nasal cannula therapy 2. A need for supplemental oxygen as demonstrated by an required FiO2 > 0.25 at enrollment 3. Requiring a flow rate of greater than 2 L/min such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of HFNC). Exclusion Criteria:

1. Major congenital abnormalities 2. Hemodynamic instability, defined as being outside of a normotensive range based on each infant's individual characteristics 3. Seizures 4. Ongoing sepsis 5. Meningitis 6. Clinician's concern regarding stability of the infant

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vapotherm, Inc.
  • Collaborator
    • Ashford and St. Peter’s Hospitals NHS Trust
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peter Reynolds, MB.BS PhD, Principal Investigator, Ashford and St. Peter’s Hospitals NHS Trust
    • George C Dungan, MPhil, Study Director, Vapotherm, Inc.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.