Back to resultsIntellO2 vs Manual Control for Optimizing Oxygenation in Infants
Primary Purpose
Oxygen Titration in Preterm Infants to Manage Lung Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
IntellO2
Manual control
Sponsored by
About this trial
This is an interventional supportive care trial for Oxygen Titration in Preterm Infants to Manage Lung Disease focused on measuring nasal cannula, high flow oxygen therapy, pulse oximetry
Eligibility Criteria
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
Sites / Locations
- Oxford University Hospitals NHS Trust
- Ashford and St. Peter's Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IntellO2
Manual
Arm Description
Automated control of FiO2
Manual control of FiO2
Outcomes
Primary Outcome Measures
Percent time in target range for oxygen saturation by pulse oximetry
Secondary Outcome Measures
Full Information
NCT ID
NCT02074774
First Posted
February 26, 2014
Last Updated
June 25, 2018
Sponsor
Vapotherm, Inc.
Collaborators
Ashford and St. Peter's Hospitals NHS Trust, Oxford University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02074774
Brief Title
IntellO2 vs Manual Control for Optimizing Oxygenation in Infants
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vapotherm, Inc.
Collaborators
Ashford and St. Peter's Hospitals NHS Trust, Oxford University Hospitals NHS Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxygen Titration in Preterm Infants to Manage Lung Disease
Keywords
nasal cannula, high flow oxygen therapy, pulse oximetry
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IntellO2
Arm Type
Experimental
Arm Description
Automated control of FiO2
Arm Title
Manual
Arm Type
Active Comparator
Arm Description
Manual control of FiO2
Intervention Type
Device
Intervention Name(s)
IntellO2
Intervention Description
Automated FiO2 regulator that responds to pulse oximetry measures
Intervention Type
Other
Intervention Name(s)
Manual control
Intervention Description
Standard practice of manually titrating FiO2 as needed.
Primary Outcome Measure Information:
Title
Percent time in target range for oxygen saturation by pulse oximetry
Time Frame
24 hrs
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Reynolds, MB.BS PhD
Organizational Affiliation
Ashford and St. Peter's Hospitals NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George C Dungan, MPhil
Organizational Affiliation
Vapotherm, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Oxford University Hospitals NHS Trust
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Ashford and St. Peter's Hospitals NHS Trust
City
Chertsey
State/Province
Surrey
ZIP/Postal Code
KT16 0QA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
30464005
Citation
Reynolds PR, Miller TL, Volakis LI, Holland N, Dungan GC, Roehr CC, Ives K. Randomised cross-over study of automated oxygen control for preterm infants receiving nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F366-F371. doi: 10.1136/archdischild-2018-315342. Epub 2018 Nov 21.
Results Reference
derived
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IntellO2 vs Manual Control for Optimizing Oxygenation in Infants
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