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| Name | Class |
|---|---|
| Maquet Cardiovascular | INDUSTRY |
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There is currently a consensus that non-invasive ventilation (NIV) in preterm infants is preferred over intubation. There are two ways of delivering NIV in preterm infants, nasal continuous positive airway pressure (CPAP) or nasal intermittent positive pressure ventilation (NIPPV), where ventilator inflations are delivered intermittently over a fixed end-expiratory pressure. The synchronization in conventional mode is very difficult to obtain in premature infants. In all ventilation modes PEEP (end-expiratory pressure) is fixed. Considering that preterm infants are more likely to develop atelectasis, an active and ongoing management of the PEEP is very important to prevent de-recruitment.
A new respiratory support system (NeuroPAP) was developed to address these issues (synchronization problems and control the PEEP). It uses the electrical activity of the diaphragm (EDI) to control the ventilator assist continuously, both during inspiration (principle of NAVA mode) and also during expiration (based on tonic Edi level).
The mode NeuroPAP will work with the continuous Edi-level and deliver pressures according to the Edi-signal x set NeuroPAP-level, over the whole breath (inspiration and expiration). The NeuroPAP will work between two pressure levels set by the user and named higher Pressure limit (Plimit) and minimum Pressure (Pmin).
A safety upper pressure limit (UPL) will also be set. A backup ventilation will be possible.
A specific gastric tube equipped with an array of microelectrodes (Edi catheter, Maquet, Solna, Sweden) will be installed after inclusion, by the same oral or nasal route as the tube previously in place. Patients will then be ventilated in the 5 aforementioned conditions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeuroBox to deliver the NeuroPAP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroBox to deliver the NeuroPAP | Device | The patients will be studied during the following conditions:
|
| Measure | Description | Time Frame |
|---|---|---|
| Time effectively spent with NeuroPAP mode activated during the NeuroPAP period | Percentage | up to 30 minutes after reinstitution of the conventional NIPPV |
| Number of interruption of NeuroPAP during the NeuroPAP period | Number of interruption per patients | up to 30 minutes after reinstitution of the conventional NIPPV |
| Change in respiratory rates between standard NIV andNeuroPAP | % of change | up to 30 minutes after reinstitution of the conventional NIPPV |
| Change in cardiac rates between standard NIV andNeuroPAP | % of change | up to 30 minutes after reinstitution of the conventional NIPPV |
| Change in blood pressure between standard NIV andNeuroPAP | % of change | up to 30 minutes after reinstitution of the conventional NIPPV |
| Change in SpO2 between standard NIV andNeuroPAP | % of change | up to 30 minutes after reinstitution of the conventional NIPPV |
| Change in TcPCO2 between standard NIV andNeuroPAP | % of change | up to 30 minutes after reinstitution of the conventional NIPPV |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent in asynchrony between standard NIV and NeuroPAP | % of time | up to 30 minutes after reinstitution of the conventional NIPPV |
| Change in trigger delays (ms) between standard NIV andNeuroPAP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume Emeriaud, MD, PhD | St. Justine's Hospital | Principal Investigator |
| Gregory Lodygensky, MD, PhD | St. Justine's Hospital | Principal Investigator |
| Jennifer Beck, PhD | Li Ka Shing Knowledge Institute. St. Michael's Hospital | Principal Investigator |
| Christer Sinderby, PhD | Li Ka Shing Knowledge Institute. St. Michael's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Justine's Hospital | Montreal | Quebec | H3T 1C5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32269148 | Derived | Rochon ME, Lodygensky G, Tabone L, Essouri S, Morneau S, Sinderby C, Beck J, Emeriaud G. Continuous neurally adjusted ventilation: a feasibility study in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2020 Nov;105(6):640-645. doi: 10.1136/archdischild-2019-318660. Epub 2020 Apr 8. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| up to 30 minutes after reinstitution of the conventional NIPPV |
| Change in non assisted breaths (wasted efforts) between standard NIV andNeuroPAP | % of change | up to 30 minutes after reinstitution of the conventional NIPPV |
| Change in autotriggered breaths between standard NIV and NeuroPAP | Percentage | up to 30 minutes after reinstitution of the conventional NIPPV |
| Change in Mean Airway pressure (cmH2O) between standard NIV and NeuroPAP | up to 30 minutes after reinstitution of the conventional NIPPV |
| Change in End expiratory pressure (PEEP, cmH2O) between standard NIV and NeuroPAP | up to 30 minutes after reinstitution of the conventional NIPPV |
| Change in Mean Electrical activity of diaphragm (Edi, mcV) between standard NIV and NeuroPAP | up to 30 minutes after reinstitution of the conventional NIPPV |
| Change in Peak Electrical activity of diaphragm (Edi, mcV) between standard NIV and NeuroPAP | up to 30 minutes after reinstitution of the conventional NIPPV |
| Change in Tonic Electrical activity of diaphragm (Edi, mcV) between standard NIV and NeuroPAP | up to 30 minutes after reinstitution of the conventional NIPPV |