Bronchopulmonary DysplasiaNCT04274192
Effect of Synchronized vs. Continuous HFNC Using NAVA on WOB in Infants With BPD
A study testing Synchronized HFNC at 6 liters per minute (LPM), Continuous HFNC at 6 liters per minute (LPM) and Synchronized HFNC at 8 liters per minute (LPM) in people with Bronchopulmonary Dysplasia, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 days to 1 year
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Synchronized HFNC at 6 liters per minute (LPM), Continuous HFNC at 6 liters per minute (LPM) and Synchronized HFNC at 8 liters per minute (LPM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2020to 28 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Major congenital anomalies of the heart and lungs
- Post menstrual age greater than 50 weeks 0 days
- Oxygen requirement greater than 40%
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
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
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.
Read the 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.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- 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)
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronized HFNC at 6 liters per minute (LPM)Other
HFNC given in synchrony with the subject's own respiratory effort using NAVA at 6 LPM
Continuous HFNC at 6 liters per minute (LPM)Other
Standard HFNC therapy at 6 LPM
Synchronized HFNC at 8 liters per minute (LPM)Other
HFNC given in synchrony with the subject's own respiratory effort using NAVA at 8 LPM
Continuous HFNC at 8 liters per minute (LPM)Other
Standard HFNC therapy at 8 LPM
| Study group | Role | What they receive |
|---|---|---|
| Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with synchronized) | Experimental | 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 Receives: Other: Synchronized HFNC at 6 liters per minute (LPM); Other: Continuous HFNC at 6 liters per minute (LPM); Other: Synchronized HFNC at 8 liters per minute (LPM); Other: Continuous HFNC at 8 liters per minute (LPM) |
| Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with continuous) | Active comparator | 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. Receives: Other: Synchronized HFNC at 6 liters per minute (LPM); Other: Continuous HFNC at 6 liters per minute (LPM); Other: Synchronized HFNC at 8 liters per minute (LPM); Other: Continuous HFNC at 8 liters per minute (LPM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work of Breathing
estimated using swing Edi
Measured: 15 minutes
Secondary outcomes (6)
Thoracoabdominal Asynchrony
estimated by phase angle calculated by data obtained from respiratory inductance plethysmography bands
Measured: 15 minutes
Uncalibrated Tidal Volume
as estimated using data from respiratory plethysmography bands
Measured: 15 minutes
FiO2 Requirement
the amount of oxygen patient requires during the study
Measured: 15 minutes
Oxygen Saturation
measured by pulse oximetry
Measured: 15 minutes
Transcutaneous Oxygen Level
using a transcutaneous oxygen monitor
Measured: 15 minutes
Transcutaneous Carbon Dioxide Level
using a transcutaneous carbon dioxide monitor
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start9 Dec 2020
- Primary completion28 Jan 2021
- Study completion28 Jan 2021
Why it stopped: PI left and study not feasible as written in the protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherry E Courtney, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274192
- Sponsor's protocol ID
- 239863
- Status last verified
- Apr 2022
- First submitted
- 29 Aug 2019
- Last updated
- 5 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04274192
- Acronym / sponsor ID
- 239863
- Conditions
- Bronchopulmonary Dysplasia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left and study not feasible as written in the protocol
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 28 Jan 2021 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Posted 8 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with synchronized) | Experimental | Other: Synchronized HFNC at 6 liters per minute (LPM), Other: Continuous HFNC at 6 liters per minute (LPM), Other: Synchronized HFNC at 8 liters per minute (LPM), Other: Continuous HFNC at 8 liters per minute (LPM)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 |
| Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with continuous) | Active comparator | Other: Synchronized HFNC at 6 liters per minute (LPM), Other: Continuous HFNC at 6 liters per minute (LPM), Other: Synchronized HFNC at 8 liters per minute (LPM), Other: Continuous HFNC at 8 liters per minute (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. |
Who may qualify
- Ages
- 28 days to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Major congenital anomalies of the heart and lungs
- Post menstrual age greater than 50 weeks 0 days
- Oxygen requirement greater than 40%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synchronized HFNC at 6 liters per minute (LPM)HFNC given in synchrony with the subject's own respiratory effort using NAVA at 6 LPM | Other | Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with continuous), Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with synchronized) |
| Continuous HFNC at 6 liters per minute (LPM)Standard HFNC therapy at 6 LPM | Other | Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with continuous), Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with synchronized) |
| Synchronized HFNC at 8 liters per minute (LPM)HFNC given in synchrony with the subject's own respiratory effort using NAVA at 8 LPM | Other | Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with continuous), Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with synchronized) |
| Continuous HFNC at 8 liters per minute (LPM)Standard HFNC therapy at 8 LPM | Other | Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with continuous), Alternating between Synchronized and Continuous HFNC at 6 and 8 LPM (starting with synchronized) |
Primary outcome
Work of Breathing
Time frame: 15 minutes
estimated using swing Edi
6 secondary outcomes
Thoracoabdominal Asynchrony
Time frame: 15 minutes
Uncalibrated Tidal Volume
Time frame: 15 minutes
FiO2 Requirement
Time frame: 15 minutes
Oxygen Saturation
Time frame: 15 minutes
Transcutaneous Oxygen Level
Time frame: 15 minutes
Transcutaneous Carbon Dioxide Level
Time frame: 15 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherry E Courtney, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synchronized HFNC at 6 liters per minute (LPM), Continuous HFNC at 6 liters per minute (LPM) and Synchronized HFNC at 8 liters per minute (LPM) in people with Bronchopulmonary Dysplasia, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work of Breathing (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.