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Effect of Synchronized vs. Continuous HFNC Using NAVA on WOB in Infants With BPD

Primary Purpose

Bronchopulmonary Dysplasia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Synchronized HFNC at 6 liters per minute (LPM)
Continuous HFNC at 6 liters per minute (LPM)
Synchronized HFNC at 8 liters per minute (LPM)
Continuous HFNC at 8 liters per minute (LPM)
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchopulmonary Dysplasia

Eligibility Criteria

28 Days - 1 Year (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronological age greater than 28 days
  • Gestational age at birth less than 32 weeks and 6 days
  • Diagnosis of BPD (supplemental oxygen requirement for greater than or equal to 28 days)
  • Currently receiving noninvasive ventilation support (NIV NAVA, NIPPV, nCPAP, HFNC)

Exclusion Criteria:

  • Major congenital anomalies of the heart and lungs
  • Post menstrual age greater than 50 weeks 0 days
  • Oxygen requirement greater than 40%

Sites / Locations

  • Arkansas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with synchronized)

Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with continuous)

Arm Description

Subjects will first receive HFNC synchronized to his/her own efforts via NAVA at 6 LPM followed by continuous HFNC at 6 LPM and then HFNC synchronized to his/her own efforts via NAVA at 8 LPM followed by continuous HFNC at 8 LPM

Subjects will first receive continuous HFNC at 6 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 6 LPM. Next, subjects will receive continuous HFNC at 8 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 8 LPM.

Outcomes

Primary Outcome Measures

Work of Breathing
estimated using swing Edi

Secondary Outcome Measures

Thoracoabdominal Asynchrony
estimated by phase angle calculated by data obtained from respiratory inductance plethysmography bands
Uncalibrated Tidal Volume
as estimated using data from respiratory plethysmography bands
FiO2 Requirement
the amount of oxygen patient requires during the study
Oxygen Saturation
measured by pulse oximetry
Transcutaneous Oxygen Level
using a transcutaneous oxygen monitor
Transcutaneous Carbon Dioxide Level
using a transcutaneous carbon dioxide monitor

Full Information

First Posted
August 29, 2019
Last Updated
April 8, 2022
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT04274192
Brief Title
Effect of Synchronized vs. Continuous HFNC Using NAVA on WOB in Infants With BPD
Official Title
Effect of Synchronized vs. Continuous High Flow Nasal Cannula Using Neurally Adjusted Ventilatory Assist on Work of Breathing in Infants With Bronchopulmonary Dysplasia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
PI left and study not feasible as written in the protocol
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
January 28, 2021 (Actual)
Study Completion Date
January 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients will be randomized to begin the study with either NAVA-synchronized or continuous HFNC. Each patient will receive two 15-minute trials at different levels of continuous HFNC and two 15-minute trials at corresponding levels of synchronized HFNC. In synchronized HFNC, using the NIV NAVA mode on the ventilator each subject will receive a constant minimum flow, but with each neurally triggered breath (as measured with an Edi catheter), an additional flow will be given to the patient. This differs from continuous HFNC in which the subject receives a constant flow without variation. Subjects will be observed during the entirety of these trials. Values for the primary and secondary outcomes will be monitored, recorded, and calculated.
Detailed Description
Prior to the study period each subject will have the following monitoring equipment placed (if not already present): Edi catheter, transcutaneous monitor (TCM4, Radiometer, Brea, CA, USA) to measure CO2 and O2 levels, pulse oximeter probe (MasimoSET, Irvine, CA, USA) to measure oxygen saturations and heart rate, and RIP bands (SleepSense, MFI Medical, San Diego, CA, USA) around the chest and abdomen to measure breathing movements and relative tidal volume. Each subject will be randomized on the day the study is to occur to begin with either NAVA-synchronized or continuous HFNC before crossing over to the other mode to serve as his/her own control. The same RAM cannula will be used in both study arms and will provide a leak of 60-80% as recommended by the product manual. The delivery of high flow during both synchronized and continuous HFNC will be given at two commonly provided levels of high flow: 6 LPM and 8 LPM, given in the same order in each mode (6 LPM then 8 LPM). Each subject will receive 15-minute trials of each mode-level combination, for a total of four trials. During each trial, the first 10 minutes will be used for stabilization, and the last 5 minutes will be used for data collection, as has been done in previous trials. Thus, the mode-level combinations of the trials will be as follows: for infants randomized to begin with synchronized support: synchronized-6 LPM, synchronized-8 LPM, unsynchronized-6 LPM, unsynchronized-8 LPM. For infants randomized to begin with unsynchronized support: unsynchronized-6 LPM, unsynchronized-8 LPM, synchronized-6 LPM, unsynchronized-8 LPM. The flows described in the NAVA-synchronized trials refer to the peak flow provided during inspiration. A baseline flow rate of 2 LPM will be provided expiration in these trials (using the PEEP setting corresponding to the appropriate flow rate). During the unsynchronized trials, the continuous high flow rate will be provided (as is common practice with the use of HFNC). During the NAVA-synchronized HFNC trials, the Edi trigger will be set to 0.5 microvolts, apnea time to 5 seconds, back up rate to 10 breaths per minute, and backup pressure settings will be set to provide an estimated peak flow of 6 or 8 LPM according to the designated trial (again, using the pressure setting corresponding to the appropriate flow rate). During NAVA-synchronized HFNC, the NIV NAVA mode will be set in such a way that synchronized HFNC will be provided. A minimal end-expiratory flow of 2 LPM will be provided using the positive end expiratory pressure (PEEP) setting in the NIV NAVA mode on the ventilator. The PEEP setting corresponding to 2 LPM via the pneumotachograph will be used. In order to deliver the desired peak flow rate with each neurally-triggered breath, a NAVA level of 15 cmH2O/μV will be set, then the maximum pressure setting that corresponds to the desired flow rate using the pneumotachograph will be used for the study. The subject will thus be provided with "synchronized HFNC". This contrasts with the constant-flow trials when subjects will receive a constant and non-synchronized flow using the HFNC software on the ventilator. Servo-u ventilators and Servo Tracker Software (Maquet Critical Care, Solna, Sweden) will be used in order to track Edi signal. The MP100 Biopac data acquisition (Biopac Systems Inc., Goleta, CA, USA) will be used to collect data from the monitoring devices. HFNC will be delivered using appropriately sized RAM cannula to allow for air leak around the subject's nares. Persistent bradycardia (less than 100 beats per minutes), desaturation (<85%), or hypercarbia (transcutaneous CO2 >70) will result in cessation of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with synchronized)
Arm Type
Experimental
Arm Description
Subjects will first receive HFNC synchronized to his/her own efforts via NAVA at 6 LPM followed by continuous HFNC at 6 LPM and then HFNC synchronized to his/her own efforts via NAVA at 8 LPM followed by continuous HFNC at 8 LPM
Arm Title
Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with continuous)
Arm Type
Active Comparator
Arm Description
Subjects will first receive continuous HFNC at 6 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 6 LPM. Next, subjects will receive continuous HFNC at 8 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 8 LPM.
Intervention Type
Other
Intervention Name(s)
Synchronized HFNC at 6 liters per minute (LPM)
Intervention Description
HFNC given in synchrony with the subject's own respiratory effort using NAVA at 6 LPM
Intervention Type
Other
Intervention Name(s)
Continuous HFNC at 6 liters per minute (LPM)
Intervention Description
Standard HFNC therapy at 6 LPM
Intervention Type
Other
Intervention Name(s)
Synchronized HFNC at 8 liters per minute (LPM)
Intervention Description
HFNC given in synchrony with the subject's own respiratory effort using NAVA at 8 LPM
Intervention Type
Other
Intervention Name(s)
Continuous HFNC at 8 liters per minute (LPM)
Intervention Description
Standard HFNC therapy at 8 LPM
Primary Outcome Measure Information:
Title
Work of Breathing
Description
estimated using swing Edi
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Thoracoabdominal Asynchrony
Description
estimated by phase angle calculated by data obtained from respiratory inductance plethysmography bands
Time Frame
15 minutes
Title
Uncalibrated Tidal Volume
Description
as estimated using data from respiratory plethysmography bands
Time Frame
15 minutes
Title
FiO2 Requirement
Description
the amount of oxygen patient requires during the study
Time Frame
15 minutes
Title
Oxygen Saturation
Description
measured by pulse oximetry
Time Frame
15 minutes
Title
Transcutaneous Oxygen Level
Description
using a transcutaneous oxygen monitor
Time Frame
15 minutes
Title
Transcutaneous Carbon Dioxide Level
Description
using a transcutaneous carbon dioxide monitor
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronological age greater than 28 days Gestational age at birth less than 32 weeks and 6 days Diagnosis of BPD (supplemental oxygen requirement for greater than or equal to 28 days) Currently receiving noninvasive ventilation support (NIV NAVA, NIPPV, nCPAP, HFNC) Exclusion Criteria: Major congenital anomalies of the heart and lungs Post menstrual age greater than 50 weeks 0 days Oxygen requirement greater than 40%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherry E Courtney, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Synchronized vs. Continuous HFNC Using NAVA on WOB in Infants With BPD

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