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The purpose of this study is
Two sessions will be recorded, one in PSV, one with NAVA, delivered in a random order after being sure the infant is calm and comfortable, according to his parents and/or the nurse in charge.
Criteria for initiating non-invasive ventilation will follow the usual practice guidelines of the unit.
Ventilation parameters in Non-invasive-Pressure Support will be adjusted by the clinician in charge of the patient, as usual based on clinical observation. Investigators will not interfere with ventilator settings. Ventilation will be applied via an endotracheal tube, uncuffed for the majority (if infant < 5 years), according to commonly applied guidelines in this unit.
One 15 minutes session will be recorded, after being sure the infant is calm and comfortable according to the parents and/or the nurse in charge. Then the clinician in charge of the patient will modify the ETS, first decreasing it of 15% (absolute value)below the initial set value, and will be recorded the following 5 minutes after stabilization and secondly increasing it of 15% (absolute value)above the initial set value, and will be recorded the following 5 minutes after stabilization.
NAVA will be set to deliver initially the same peak pressure (comparable level of assist) than during the initial PS period. Same PEEP will be delivered in both modes. This is possible with a pre-visualization window, allowing adjustments before switching to the NAVA mode. Nava non-invasive-ventilation will be recorded during 20 minutes.
The 2 sessions, Pressure support and Nava, will be recorded consecutively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Invasive Pressure support | Active Comparator | in this arm, non-invasive pressure support will be recorded under 3 conditions: with the initial Expiratory Trigger Setting (ETS) with ETS +15% with ETS -15% |
|
| NAVA | Active Comparator | Neurally Adjusted ventilatory Assist is a ventilation mode where the ventilator is piloted by the electrical activity of the diaphragm. Ventilation is triggered and cycled off by the electrical activity of the diaphragm, the pressure delivered being proportional to this activity. The proportion named gain is chosen to obtain under NAVA the same peak pressure than during Presure Support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive Ventilation under Pressure Support | Other | Non-invasive Ventilation under Pressure Support: 15 min with initial settings, 5 min with ETS-%%, 5 min with ETS+10%, in random order |
| Measure | Description | Time Frame |
|---|---|---|
| asynchronies | Asynchronies during mechanical ventilation are the following: Auto triggering, double triggering, late cycling, premature cycling and ineffective effort. all ventilatory parameters are recorded under non-invasive-Pressure support (3 phases: 3 levels of expiratory trigger setting, initial, +15% and -15%, 15 min, 5 min and 5 min respectively) and NAVA (1 phase, 20 min). Asynchronies will be determined by measuring each ventilatory cycle of all recordings. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Rimensberger, MD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital of Geneva | Geneva | Canton of Geneva | 1211 | Switzerland |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 2, 2018 | |
| Reset | Nov 30, 2018 |
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| Non-Invasive ventilation under NAVA | Other | 20 min session under non-invasive ventilation with NAVA |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 2, 2018 | Nov 30, 2018 |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059725 | Interactive Ventilatory Support |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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