Not provided
Not provided
Not provided
Not provided
Very small percentage of enrolled patients needing non-invasive support and small chance of us reaching target enrollment within funding period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Pediatric patients often require prolonged mechanical ventilation after cardiac surgery which comes with many undesirable effects. As a result, neurally-adjusted ventilatory assist (NAVA) and biphasic positive airway pressure support (BiPAP) have been developed as non-invasive alternatives to providing respiratory support post-operatively. The investigators hypothesize that providing synchronized biphasic support with NAVA will be associated with shorter duration of non-invasive respiratory support, less sedation requirements, and reduced length of hospital stay. This is a prospective, randomized study. Subjects are randomized to receive either NAVA or BiPAP following their cardiothoracic surgery.
Mechanical ventilation is often very necessary in the care of critically ill pediatric patients. However, it comes with many different complications that include chronic lung disease, tissue damage, and ventilator-associated pneumonia. Over time, we have increased our understanding of how a child's physiology interacts with a ventilator and this has led to two different non-invasive forms of respiratory support: bilevel positive air pressure (BiPAP) and neurally adjusted ventilator assist (NAVA). While both modalities come with a lot of benefits such as improved gas exchange, decreased respiratory and heart rate and decreased inspiratory work of breathing, NAVA has the ability to provide synchronous ventilatory support due to the electrical activity of the diaphragm.
The purpose of this study is to compare clinical outcomes following use of NAVA versus BiPAP in patients undergoing cardiac surgery, Specifically, comparisons of non-invasive respiratory support, duration of sedation, and length of hospital stay. The investigators hypothesize that the use of NAVA will lead to a shorter duration of non-invasive respiratory support, less sedation requirements, and reduced length of hospital stay compared to the use of BiPAP.
This is a single-site, prospective randomized study. Subjects are randomized into two arms: those who receive NAVA and those who receive BiPAP post-operatively.
Subjects will be followed for up to 14 days post-operatively or until they are discharged, whichever comes first. Pain medication administered, FLACC (Face, Legs, Activity, Cry, Consolability), and SBS (State Behavioral Scale) scores are recorded daily for up to 14 days.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurally-Adjusted Ventilatory Assist (NAVA) | Experimental | Synchronized biphasic non-invasive respiratory support |
|
| Biphasic Positive Airway Pressure Support (BiPAP) | Active Comparator | Conventional non-invasive respiratory support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurally-Adusted Ventilatory Assist (NAVA) | Device | Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Post-operative Midazolam Dose | Up to 14 days post-operatively | |
| Post-operative Pain Scores-FLACC | FLACC (Face, Legs, Activity, Cry, Consolability) scale | Up to 14 days post-operatively |
| Post-operative Sedation Scores-SBS | SBS (State Behavioral Scale) | Up to 14 days post-operatively |
| Length of Intubation | Up to 14 days post-operatively | |
| Length of Non-Invasive Respiratory Support | Up to 14 days post-operatively | |
| Average Post-operative Morphine Dose | Up to 14 days post-operatively | |
| Average Post-operative Lorazepam Dose | Up to 14 days post-operatively | |
| Average Post-operative Dexmedetomidine Dose | Up to 14 days post-operatively | |
| Average Post-operative Total Fentanyl Dose | Up to 14 days post-operatively | |
| Average Post-operative PCA Fentanyl Dose | Up to 14 days post-operatively |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Documented airway malformation (congenital or acquired)
Documented ENT abnormality
Documented central apnea
Patients who are overly sedated, per provider discretion
Tracheostomy in place at time of cardiac surgery
Documented phrenic nerve paralysis (Note: Vocal cord paresis and paralysis will not be an exclusion)
Other chromosomal abnormality (non-Down syndrome)
Chronic lung disease
Pre-operative non-invasive respiratory support
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gretchen A McGuire, RN, MSN, CPNP-AC | Children's Hospitals and Clinics of Minnesota | Principal Investigator |
| Robert Horvath-Csongradi, MD | Children's Hospitals and Clinics of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota | 55404 | United States |
Informed consent was obtained for 15 participants. However, the reason there are only 2 participants listed under "total started in participant flow" is because these were the only participants who were actually randomized. The other 13 participants were extubated and did not need BiPAP/NAVA. They were not randomized and were excluded.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Neurally-Adjusted Ventilatory Assist (NAVA) | Synchronized biphasic non-invasive respiratory support Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Jan 10, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Biphasic Positive Airway Pressure Support (BiPAP) | Device | Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion. |
|
| FG001 | Biphasic Positive Airway Pressure Support (BiPAP) | Conventional non-invasive respiratory support Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion. |
| COMPLETED |
|
| NOT COMPLETED |
|
No patients who were enrolled in the study and needed non-invasive respiratory support post-cardiac surgery were randomized to NAVA, only BiPAP.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Neurally-Adjusted Ventilatory Assist (NAVA) | Synchronized biphasic non-invasive respiratory support Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient. |
| BG001 | Biphasic Positive Airway Pressure Support (BiPAP) | Conventional non-invasive respiratory support Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion. |
| 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 | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Average Post-operative Midazolam Dose | All patients who were randomized ended up in the BiPAP group and not the NAVA group. | Posted | Mean | Standard Deviation | mg/kg | Up to 14 days post-operatively |
|
|
| |||||||||||||||||||||||||||||
| Primary | Post-operative Pain Scores-FLACC | FLACC (Face, Legs, Activity, Cry, Consolability) scale | There were no FLACC scores in the electronic medical record for either of these 2 participants so this is why there are no results reported. | Posted | Up to 14 days post-operatively |
|
| ||||||||||||||||||||||||||||||||
| Primary | Post-operative Sedation Scores-SBS | SBS (State Behavioral Scale) | There were no SBS scores in the electronic medical record for either of these 2 participants so this is why results were not reported. | Posted | Up to 14 days post-operatively |
|
| ||||||||||||||||||||||||||||||||
| Primary | Length of Intubation | All patients who were randomized ended up in the BiPAP group and not the NAVA group. | Posted | Mean | Standard Deviation | hours | Up to 14 days post-operatively |
|
| ||||||||||||||||||||||||||||||
| Primary | Length of Non-Invasive Respiratory Support | For this outcome, data for only one participant is available | Posted | Number | hours | Up to 14 days post-operatively |
|
| |||||||||||||||||||||||||||||||
| Primary | Average Post-operative Morphine Dose | All patients who were randomized ended up in the BiPAP group and not the NAVA group. | Posted | Mean | Standard Deviation | mg/kg | Up to 14 days post-operatively |
|
| ||||||||||||||||||||||||||||||
| Primary | Average Post-operative Lorazepam Dose | All patients who were randomized ended up in the BiPAP group and not the NAVA group. | Posted | Mean | Standard Deviation | mg/kg | Up to 14 days post-operatively |
|
| ||||||||||||||||||||||||||||||
| Primary | Average Post-operative Dexmedetomidine Dose | All patients who were randomized ended up in the BiPAP group and not the NAVA group. | Posted | Mean | Standard Deviation | mcg/kg | Up to 14 days post-operatively |
|
| ||||||||||||||||||||||||||||||
| Primary | Average Post-operative Total Fentanyl Dose | All patients who were randomized ended up in the BiPAP group and not the NAVA group. | Posted | Mean | Standard Deviation | mcg/kg | Up to 14 days post-operatively |
|
| ||||||||||||||||||||||||||||||
| Primary | Average Post-operative PCA Fentanyl Dose | All patients who were randomized ended up in the BiPAP group and not the NAVA group. | Posted | Mean | Standard Deviation | boluses | Up to 14 days post-operatively |
|
|
Adverse event data was collected over the span of the patient's hospital stay, specifically up to 14 days post-cardiac surgery.
Adverse events were assessed via review of daily progress notes by both cardiology and cardiac intensive care providers within the electronic medical record (EMR).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neurally-Adjusted Ventilatory Assist (NAVA) | Synchronized biphasic non-invasive respiratory support Neurally-Adusted Ventilatory Assist (NAVA): Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Biphasic Positive Airway Pressure Support (BiPAP) | Conventional non-invasive respiratory support Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion. | 0 | 2 | 1 | 2 | 0 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Re-intubation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Patient had desaturation episode to 29% and was subsequently re-intubated on post-operative day #2. |
|
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Lo Galbo, MPH, CCRP | Children's Hospitals and Clinics of Minnesota | (612)-813-7828 | mark.logalbo@childrensmn.org |
| Aug 15, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|