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PI left and study not feasible as written in the protocol
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Work of Breathing | estimated using swing Edi | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Thoracoabdominal Asynchrony | estimated by phase angle calculated by data obtained from respiratory inductance plethysmography bands | 15 minutes |
| Uncalibrated Tidal Volume | as estimated using data from respiratory plethysmography bands |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherry E Courtney, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States |
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Only one participant was enrolled. The study was subsequently stopped.
Reasons:
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| ID | Title | Description |
|---|---|---|
| FG000 | Synchronized HFNC First | 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 |
| FG001 | Continuous HFNC First |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2021 |
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| 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 |
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| Continuous HFNC at 8 liters per minute (LPM) | Other | Standard HFNC therapy at 8 LPM |
|
| 15 minutes |
| FiO2 Requirement | the amount of oxygen patient requires during the study | 15 minutes |
| Oxygen Saturation | measured by pulse oximetry | 15 minutes |
| Transcutaneous Oxygen Level | using a transcutaneous oxygen monitor | 15 minutes |
| Transcutaneous Carbon Dioxide Level | using a transcutaneous carbon dioxide monitor | 15 minutes |
Subjects will first receive continuous HFNC at 6 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 6 LPM and then continuous HFNC at 8 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 8 LPM. |
| COMPLETED | Using the equipment available, we were unable to administer the 6 LPM (per the protocol), so this subject did not receive all of the interventions and therefore did not complete the study. We subsequently terminated the study due to lack of protocol feasibility and the departure of the original PI. |
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| NOT COMPLETED |
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|
Using the equipment available, we were unable to administer the 6 LPM (per the protocol), so this subject could not receive all of the interventions described in the protocol and therefore did not complete the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Synchronized HFNC First | 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 |
| BG001 | Continuous HFNC First | Subjects will first receive continuous HFNC at 6 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 6 LPM and then continuous HFNC at 8 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 8 LPM. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | days |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Patient was caucasian. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Work of Breathing | estimated using swing Edi | Only one patient was enrolled, but that subject did not complete the study due to a protocol violation related to a lack of protocol feasibility with the equipment available. Therefore, there are no outcome data. | Posted | 15 minutes |
|
| ||||||||||||||||||||||
| Secondary | Thoracoabdominal Asynchrony | estimated by phase angle calculated by data obtained from respiratory inductance plethysmography bands | Only one patient was enrolled, but that subject did not complete the study due to a protocol violation related to a lack of protocol feasibility with the equipment available. Therefore, there are no outcome data. | Posted | 15 minutes |
|
| ||||||||||||||||||||||
| Secondary | Uncalibrated Tidal Volume | as estimated using data from respiratory plethysmography bands | Only one patient was enrolled, but that subject did not complete the study due to a protocol violation related to a lack of protocol feasibility with the equipment available. Therefore, there are no outcome data. | Posted | 15 minutes |
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| ||||||||||||||||||||||
| Secondary | FiO2 Requirement | the amount of oxygen patient requires during the study | Only one patient was enrolled, but that subject did not complete the study due to a protocol violation related to a lack of protocol feasibility with the equipment available. Therefore, there are no outcome data. | Posted | 15 minutes |
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| ||||||||||||||||||||||
| Secondary | Oxygen Saturation | measured by pulse oximetry | Only one patient was enrolled, but that subject did not complete the study due to a protocol violation related to a lack of protocol feasibility with the equipment available. Therefore, there are no outcome data. | Posted | 15 minutes |
|
| ||||||||||||||||||||||
| Secondary | Transcutaneous Oxygen Level | using a transcutaneous oxygen monitor | Only one patient was enrolled, but that subject did not complete the study due to a protocol violation related to a lack of protocol feasibility with the equipment available. Therefore, there are no outcome data. | Posted | 15 minutes |
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| ||||||||||||||||||||||
| Secondary | Transcutaneous Carbon Dioxide Level | using a transcutaneous carbon dioxide monitor | Only one patient was enrolled, but that subject did not complete the study due to a protocol violation related to a lack of protocol feasibility with the equipment available. Therefore, there are no outcome data. | Posted | 15 minutes |
|
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Until the end of the treatment, approximately 1 day per subject
0 subjects were enrolled in the "continuous HFNC" arm, therefore 0 were at risk for SAEs, All-cause mortality, or Other AEs
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Synchronized HFNC First | 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 | 0 | 1 | 0 | 1 | 1 | 1 |
| EG001 | Continuous HFNC First | Subjects will first receive continuous HFNC at 6 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 6 LPM and then continuous HFNC at 8 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 8 LPM. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Study team error | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Nothing adverse occurred and the event was a result of a safety precaution we were not aware of on the ventilator, which did not permit pressure recording low enough for 6LPM during the NAVA data collection. |
|
Using the equipment available, we were unable to administer the 6 LPM (per the protocol), so this subject did not receive all of the interventions and therefore did not complete the study.
We subsequently terminated the study due to lack of protocol feasibility and the departure of the original PI.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sherry Courtney | University of Arkansas for Medical Sciences | 501-364-1028 | SECourtney@uams.edu |
| Nov 29, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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