NICU Automatic Oxygen Control With Parameter and Disturbance Estimation

Overview

This study uses a randomized crossover design to study the performance of an automatic oxygen control device compared to manual control by nurses. Inspired oxygen is controlled with the goal of maintaining the blood oxygen saturation in a desired range. Prematurely born infants in the hospital neonatal intensive care unit (NICU) will be included in the study.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2022

Detailed Description

This is a randomized crossover study to show that an automated oxygen control device performance is no worse than a NICU nurse in keeping a premature neonate's SPO2 within the prescribed range. Since subjects receive the device (automatic oxygen control) and the standard of care (manual control by a nurse), every subject serves as their own perfectly matched control. Performance measures include the average time it takes for the SpO2 to return to the desired range (primary endpoint) and the total amount of time that the SpO2 is within the desired range (secondary endpoint). The device will be applied to premature infants on respiratory support humidified high flow nasal cannula (HFNC) with oxygen controlled using a blend valve. Two groups include one that begins the study period with the device and one that begins the study period without the device. The two groups are switched between manual and automatic every 6 hours into the trial period and complete a total of 6 days. The target number of subjects is 48. We will analyze the study as a superiority trial if there is strong evidence of superiority.

Interventions

  • Device: Automatic control of inspired oxygen
    • A device will be used to automatically adjust the blend of oxygen and air with the ability to return to manual control as needed.

Arms, Groups and Cohorts

  • Experimental: Automatic Oxygen Control
    • In this arm, an automatic oxygen control device will be used to make adjustments to the blend of oxygen and air supplied to the subject.
  • No Intervention: Manual Oxygen Control
    • In this arm, a nurse will manually make adjustments to the blend of oxygen and air supplied to the subject as in the standard of care.

Clinical Trial Outcome Measures

Primary Measures

  • Nurse elapsed time to respond to SpO2 alarm.
    • Time Frame: Desaturation events occurring over the 12 6-hour manual study periods.
    • Mean elapsed time needed for the nurse to re- establish SpO2 within the desired range after an alarm. The alarms and alarm times are recorded directly from the bedside monitor and the responses are measured directly in terms of the blend valve position and SpO2 response measured by the pulse oximeter.
  • Device elapsed time to respond to SpO2 alarm.
    • Time Frame: Desaturation events occurring over the 12 6-hour manual study periods.
    • Mean elapsed time needed for the device to re- establish SpO2 within the desired range after an alarm. The alarms and alarm times are recorded directly from the bedside monitor and the responses are measured directly in terms of the blend valve position and SpO2 response measured by the pulse oximeter.

Secondary Measures

  • Time SpO2 is within the prescribed range for manual control by the nurse.
    • Time Frame: The 12 6-hour manual study periods.
    • Proportion of time SpO2 is within the prescribed range computed using an area-under-the-curve approach for data taken during manual control by the nurse.
  • Time SpO2 is within the prescribed range for automatic control by the device.
    • Time Frame: The 12 6-hour manual study periods.
    • Proportion of time SpO2 is within the prescribed range computed using an area-under-the-curve approach for data taken during automatic control using the device.

Participating in This Clinical Trial

Inclusion Criteria

  • Infants admitted to the NICU
  • Less than 34 weeks estimated gestational age or less than 1500 grams at birth
  • Currently on high flow nasal cannula

Exclusion Criteria

  • Infants admitted to the NICU with congenital heart disease
  • Infants admitted to the NICU whose pulse oximeter range is not set at the 87-95% range by their healthcare team.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Missouri-Columbia
  • Collaborator
    • Sacred Heart Health System
  • Provider of Information About this Clinical Study
    • Principal Investigator: Roger Fales, Associate Professor of Mechanical and Aerospace Engineering – University of Missouri-Columbia
  • Overall Official(s)
    • John A Pardalos, MD, Principal Investigator, University of Missouri-Columbia
  • Overall Contact(s)
    • John A Pardalos, MD, (573) 882-2272, Pardalosj@health.missouri.edu

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