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IntellO2 vs Manual Control for Optimizing Oxygenation in Infants

NCT02074774 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-06-27

No results posted yet for this study

Summary

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.

Conditions

  • Oxygen Titration in Preterm Infants to Manage Lung Disease

Interventions

DEVICE

IntellO2

Automated FiO2 regulator that responds to pulse oximetry measures

OTHER

Manual control

Standard practice of manually titrating FiO2 as needed.

Sponsors & Collaborators

  • Ashford and St. Peter's Hospitals NHS Trust

    collaborator OTHER

  • Oxford University Hospitals NHS Trust

    collaborator OTHER

  • Vapotherm, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter Reynolds, MB.BS PhD · Ashford and St. Peter's Hospitals NHS Trust

  • George C Dungan, MPhil · Vapotherm, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-12-31
Completion
2018-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02074774 on ClinicalTrials.gov