IntellO2 vs Manual Control for Optimizing Oxygenation in Infants

Not Applicable

Completed

• Conditions: Oxygen Titration in Preterm Infants to Manage Lung Disease
• Interventions: Device: IntellO2; Other: Manual control

• Registration Number: NCT02074774
• Lead Sponsor: Vapotherm, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-02-28
• Study Start: 2016-12
• Primary Completion: 2017-12
• Study Completion: 2018-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-25
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IntellO2	IntellO2	Automated control of FiO2
Manual	Manual control	Manual control of FiO2

Primary Outcome Measures

Name	Time	Method
Percent time in target range for oxygen saturation by pulse oximetry	24 hrs

Trial Locations

Locations (2)

Oxford University Hospitals NHS Trust; 🇬🇧 Oxford, Oxfordshire, United Kingdom

Ashford and St. Peter's Hospitals NHS Trust; 🇬🇧 Chertsey, Surrey, United Kingdom