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OpenTrials
Completed

NCT Number: NCT02074774

IntellO2 vs Manual Control for Optimizing Oxygenation in Infants

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.

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Key information

Conditions

Oxygen Titration in Preterm Infants to Manage Lung Disease

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oxford University Hospitals NHS Trust, Oxford, Oxfordshire, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preterm infants being treated with high flow nasal cannula therapy
  • A need for supplemental oxygen as demonstrated by an required FiO2 > 0.25 at enrollment
  • 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

  • Major congenital abnormalities
  • Hemodynamic instability, defined as being outside of a normotensive range based on each infant's individual characteristics
  • Seizures
  • Ongoing sepsis
  • Meningitis
  • Clinician's concern regarding stability of the infant

Treatment and study plan

IntellO2

Device

Automated FiO2 regulator that responds to pulse oximetry measures

Manual control

Other

Standard practice of manually titrating FiO2 as needed.

Primary outcomes

  1. Percent time in target range for oxygen saturation by pulse oximetry

    Time frame: 24 hrs

Sponsors and collaborators

Lead sponsor

Vapotherm, Inc.

Industry

Collaborators

  • Ashford and St. Peter's Hospitals NHS Trust
  • Oxford University Hospitals NHS Trust

Registry information

Official study title

Comparison of the IntellO2 - Precision Flow Automatic FiO2 Controller to Manual Control for Optimizing Oxygenation in Preterm Infants Receiving High Flow Nasal Cannula Therapy

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 28, 2014
Registry last updated
Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.