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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00717-38 | Other Identifier | ANSM |
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The NAVA, by its more physiological aspect and a better adaptation of the patient to the ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration of weaning and so decrease the duration of invasive mechanical ventilation and the morbi-mortality. The objective of this study is to compare the neurally adjusted ventilatory assist versus the usual management of weaning from mechanical ventilation, in term of duration of weaning, at the patients in period of difficult weaning from the invasive mechanical ventilation.
- Background: The NAVA is a new mode of ventilation which works from the continuous recording of the electromyogram of the diaphragm. In theory, the NAVA delivred a proportional and synchronous assistance, to respiratory efforts allowing a more adequate ventilatory support. However, no study estimates the NAVA in the weaning from mechanical ventilation.
- Purpose: The NAVA, by its more physiological aspect and a better adaptation of the patient to the ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration of weaning and so decrease the duration of invasive mechanical ventilation and the morbi-mortality. The objective of this study is to compare the neurally adjusted ventilatory assist versus the usual management of weaning from mechanical ventilation, in term of duration of weaning, at the patients in period of difficult weaning from the invasive mechanical ventilation.
- Detailed description: Approximately 20 to 25 % of the patients under mechanical ventilation who have the general criteria of weaning will not pass a first SBT (Spontaneous Breathing Trial). At this moment, the management of the weaning ventilatoire are made with PSV. The NAVA is proportional assistance and depends on the intensity of the electric diaphragmatic signal (Edi). The respiratory effort of the patient is directly detected from the Edi signal. In theory, the NAVA is a proportional and synchronous respiratory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAVA group | Experimental | Management of the difficult weaning from mechanical ventilation by the NAVA. |
|
| Control group | Active Comparator | Conventional management of the difficult weaning from mechanical ventilation, with the pressure ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurally adjusted ventilatory assist | Device | In the NAVA group, the level of NAVA is daily adjusted to obtain Eadimax corresponding to 60 % of Eadimax of the patient during the SBT to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of weaning from the mechanical invasive ventilation. | This duration is defined by the period between the first failure of the spontaneous breathing trial (SBT) and 48 hours after the extubation. | 48 hours after the extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Duration between the inclusion and the success of the SBT | 28th day | |
| Duration of invasive mechanical ventilation | 28th day | |
| Rate of failure of SBT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul PEREZ, Doctor | University Hospital, Bordeaux | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux Hôpital Pellegrin | Bordeaux | Aquitaine | 33000 | France |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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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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| Noninvasive pressure support ventilation | Device | In the control group, the PSV is decreased of 2cmH2O daily or several times a day to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg. |
|
| 28th day |
| Rate of success of SBT | 28th day |
| Rate of ventilator-associated pneumonia | 28th day |
| Length of intensive care unit stay | 28th day |
| Duration of hospitalization | 28th day |