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NICU Oxygen Control Study

Primary Purpose

Hyperoxia, Hypoxia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automatic control of inspired oxygen
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperoxia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infants admitted to the NICU
  • Less than 31 weeks estimated gestational age or less than 1500 grams at birth
  • Currently on high flow nasal cannulaor bubble CPAP

Exclusion Criteria:

  • Infants admitted to the NICU with congenital heart disease

Sites / Locations

  • Studer Family Children's Hospital at Sacred HeartRecruiting
  • University of MissouriRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Automatic Oxygen Control

Manual Oxygen Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Nurse elapsed time to respond to SpO2 alarm.
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.
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 Outcome Measures

Time SpO2 is within the prescribed range for manual control by the nurse.
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.
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.

Full Information

First Posted
February 11, 2020
Last Updated
May 19, 2023
Sponsor
University of Missouri-Columbia
Collaborators
Sacred Heart Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04269161
Brief Title
NICU Oxygen Control Study
Official Title
NICU Oxygen Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
May 17, 2024 (Anticipated)
Study Completion Date
May 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
Sacred Heart Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prematurely born infants in the hospital neonatal intensive care unit (NICU) will be included in the study. This clinical trial is a randomized crossover study to show that our 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 60. We will analyze the study as a superiority trial if there is strong evidence of superiority.
Detailed Description
We intend to enroll between 20-30 subjects at each of two separate institutions (University of Missouri Women's and Children's Hospital and Studer Family Children's Hospital in Pensacola, FL). The subjects will be premature infants <34 weeks post conceptual age (PCA) requiring respiratory support. This randomized clinical trial will utilize a 24 period 2 treatment crossover design to show that the device performs no worse than (non-inferiority trial) an NICU nurse in keeping a premature neonate's SpO2 within the prescribed range while the infant is on respiratory support. Due to the nature of the study, any masking of the intervention is not possible. Upon enrollment, the subjects will be randomized into enrollment in two groups (A and B). The primary endpoint will be the mean time required to re-establish SpO2 within the prescribed range, as measured from the time an out-of-range alarm is triggered. A secondary endpoint will be proportion of time SpO2 is within the prescribed range, using an area-under-the-curve approach (with a discrete state) to account for varying time-on-test. These outcome measures are complementary because the former doesn't account for the number of alarms, while the latter does. This is important because the oxygen control device operates continuously in a proactive manner, rather than only reacting due alarms, so it is doing more than mimicking the nurse -- the second measure allows us to capture that. Group A will initially have the automatic device interface with HFNC for 6 hours. The device will have the target SpO2 parameters ordered by the treating physician input into the device. A study laptop will interface with the device, cardiopulmonary monitor, and pulse oximeter to record the data for the study. Sensors will be used to record all adjustments to the device/respiratory support equipment (i.e. blend valve and flow valve used in HFNC). These sensors will continuously record the data for later analysis. The device will constantly evaluate data sent to it from the pulse oximeter and bedside monitor recording all of the data and alarms. In response to alarms, displayed data, doctor's orders, etc., nurses will continue to apply manual inputs to make adjustments to flow and provide tactile stimulus to the subject but not adjust FiO2 unless manual mode is selected. Recorded sensor measurements and manual inputs by the nurse will be used to refine the existing models as well as new models of response in HR, RR, and SpO2 to flow adjustments and tactile stimulus. After the first 6 hours, the device will be switched to manual mode for the subject (nurse makes all adjustments for FiO2), but the laptop and sensor data logging system will continue to record data from the patient and the respiratory support equipment. This will record the information for the nurse intervention/baseline care part of the study, which continue for 6 hours. During the entire process, the bedside nurse will keep a diary of any events/interventions using the time prominently displayed on the monitoring laptop. This "time-stamped" diary system will allow for easier retrieval of and comparison to the data from the device and monitoring laptop. Also, the monitoring laptop will have a record of all the data, including alarms from the pulse oximeter as well as the bedside monitor to allow for easier retrieval of data related to alarm events and interventions. The laptop will also record any interventions made by the device to allow for easier retrieval of data related to device interventions. The treatment will then alternate periods of each treatment for a total of 6 days (24 6-hour periods). Group B will have the exact opposite order as group A. Group B infants will initially have the laptop interface with all of the monitors and sensor measurements. However, the nurse intervention/baseline care stage of the study will take place for the first 6 hours. Next, group B will have the device interface with their respiratory equipment, and the data will be recorded as described above for the next 6 hours of the study. The the treatment will alternate every 6 hours for a total of 6 days. This design was chosen because the premature infants should have fewer events as they grow older each day, and it will help take into account this potential bias. Also, the subjects will be randomized to group A or B in sets of 8 (i.e. in each group of 8 envelopes, 4 will be group A and 4 will be group B). During the entire study process the infants will receive normal NICU care and the parameters for the SpO2 range will be set by the physician caring for the infant. There are also built in manual overrides for the device which allow the NICU to make changes while the subject is on the device phase of the study. The device will be able to record these changes and the staff will record their manual interventions in the study diary. We have planned our sample size using a non-inferiority test for a cross-over design, based on our primary endpoint, t_delta. For a given patient, define t_delta = (mean elapsed time needed for device to re-establish SpO2 after alarm) - (mean elapsed time needed for nurse to re-establish SpO2 after alarm). The margin of non- inferiority will be chosen as t_delta > -10 sec, so that a device which is no worse than 10 sec, on average, than a nurse will be considered non-inferior. Assuming the standard deviation of t_delta =12 and the true mean difference is zero under the alternate hypothesis, a sample size of 48 achieves 88% with alpha=0.05. If there is 16% patient drop-out before crossover, so that the final n=40, the power drops to 82%. In all analysis, a (paired) t-test will be used. Our secondary endpoint is secondary endpoint is the proportion of time SpO2 is within the prescribed range, using an area-under-the-curve approach (with a discrete state) to account for varying time-on-test. Our secondary endpoint will be analyzed in a similar manner. We will plan for one interim analysis to determine if the trial should be stoopped early due to futility (strong evidence of inferiority, where a confidence interval for t_delta lies entirely to the left of -10 and doesn't intersect -10) or for efficacy (strong evidence of superiority with margin > +20 sec). This will be carried out when n=32 (16 subjects per site) is attained and stopping decisions will be based on O'Brien-Fleming stopping principles. The interim analysis will be carried out by an independent statistician on the University of Missouri's Data Safety and Monitoring Committee, which is also available to monitor the study for adverse events if requested by the IRB. In the event that the patient drop-out is greater than 16% before crossover, then a more complicated estimation procedure will be employed using mixed effects models; otherwise, complete cases will be used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperoxia, Hypoxia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Automatic Oxygen Control
Arm Type
Experimental
Arm Description
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.
Arm Title
Manual Oxygen Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Automatic control of inspired oxygen
Intervention Description
A device will be used to automatically adjust the blend of oxygen and air with the ability to return to manual control as needed.
Primary Outcome Measure Information:
Title
Nurse elapsed time to respond to SpO2 alarm.
Description
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.
Time Frame
Desaturation events occurring over the 12 6-hour manual study periods.
Title
Device elapsed time to respond to SpO2 alarm.
Description
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.
Time Frame
Desaturation events occurring over the 12 6-hour manual study periods.
Secondary Outcome Measure Information:
Title
Time SpO2 is within the prescribed range for manual control by the nurse.
Description
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 Frame
The 12 6-hour manual study periods.
Title
Time SpO2 is within the prescribed range for automatic control by the device.
Description
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.
Time Frame
The 12 6-hour manual study periods.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants admitted to the NICU Less than 31 weeks estimated gestational age or less than 1500 grams at birth Currently on high flow nasal cannula or bubble CPAP Require at least 2 adjustments to the FiO2 per shift and/or have at least 2 desaturation events per shift Exclusion Criteria: Infants admitted to the NICU with congenital heart disease. Infants who are set on a minimum FiO2 set point by their healthcare provider
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John A Pardalos, MD
Phone
(573) 882-2272
Email
Pardalosj@health.missouri.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Pardalos, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Studer Family Children's Hospital at Sacred Heart
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32513-2700
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramak R Amjad, MD
Phone
850-416-7000
First Name & Middle Initial & Last Name & Degree
Ramak R Amjad, MD
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John A Pardalos, MD
Phone
573-882-2272
Email
Pardalosj@health.missouri.edu
First Name & Middle Initial & Last Name & Degree
John A Pardalos, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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NICU Oxygen Control Study

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