IntellO2 vs Manual Control for Optimizing Oxygenation in Infants

Oxygen Titration in Preterm Infants to Manage Lung Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074774
• Other study ID #: RP-NIAE2014001Reg
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: January 2018

Study information

• Verified date: June 2018
• Source: Vapotherm, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Oxygen Titration in Preterm Infants to Manage Lung Disease
• Premature Birth

Intervention

Device:
• IntellO2
Automated FiO2 regulator that responds to pulse oximetry measures

Other:
• Manual control
Standard practice of manually titrating FiO2 as needed.

Locations

Country	Name	City	State
United Kingdom	Ashford and St. Peter's Hospitals NHS Trust	Chertsey	Surrey
United Kingdom	Oxford University Hospitals NHS Trust	Oxford	Oxfordshire

Sponsors (3)

Lead Sponsor	Collaborator
Vapotherm, Inc.	Ashford and St. Peter's Hospitals NHS Trust, Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent time in target range for oxygen saturation by pulse oximetry		24 hrs