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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00559-32 | Other Identifier | ANSM |
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This is a multicenter, prospective, randomized, open-label study which compared two ventilation modes: spontaneous NAVA mode and spontaneous breathing with IPS mode (the latter is considered as the reference ventilatory mode) in patients admitted to the ICU for acute respiratory failure and ventilated with an endotracheal tube. NAVA mode allows to minimize patient-ventilator disharmony with acceptable tolerance and to preserve spontaneous ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| spontaneous NAVA mode | Experimental |
| |
| Inspiratory pressure support (IPS) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAVA endotracheal tube | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the benefit of NAVA mode as compared to IPS mode in terms of duration of spontaneous ventilation 48 hours after inclusion. | The time spent in different modes of spontaneous ventilation (NAVA, IPS) and controlled ventilation (VAC controlled pressure) will be measured. The primary endpoint will be the proportion of patients remaining in spontaneous ventilation after the first 48 hours. | Continuous recording during 48 hours following the intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of patient / ventilator disharmony, measured during the first 48 hours with the disharmony index | Continuous recording during the first 48 hours | |
| Real-time spent in NAVA mode and frequency of returns in a controlled mode (controlled ventilation VAC). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of implementation failure of the NAVA endotracheal tube. | For each patient, the success or failure of the endotracheal tube implementation will be evaluated, this for the entire duration of the study estimated to 18 months | |
| Number and duration of automatic switch into IPS mode |
Inclusion Criteria:
Patient ventilated with endotracheal tube for more than 24 hours
Return for at least 30 minutes to spontaneous ventilation allowing IPS with a level of pressure support <30 cm H2O;
Level of sedation =< 4 on the Ramsay scale in the absence of medical decision to increase the level of sedation;
Fraction of inspired oxygen (FiO 2) =< 50% with a positive end-expiratory pressure (PEEP) =< 8 cm H2O;
Absence of administration of high-dose vasopressor therapy defined by:
Estimated duration of mechanical ventilation > 48h00
Exclusion Criteria:
Contraindication to the implementation of the NAVA endotracheal tube, ie any contraindication to the implementation of a gastric tube or to the repositioning of a tube already in place:
Therapeutic limitation or active treatment discontinuation;
Pregnant women;
Minors;
Protected adults;
Patient already included in the study;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital L'Archet 1 | Nice | Alpes Maritimes | 06202 | France | ||
| Hopital de la CROIX ROUSSE |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27686347 | Derived | Demoule A, Clavel M, Rolland-Debord C, Perbet S, Terzi N, Kouatchet A, Wallet F, Roze H, Vargas F, Guerin C, Dellamonica J, Jaber S, Brochard L, Similowski T. Neurally adjusted ventilatory assist as an alternative to pressure support ventilation in adults: a French multicentre randomized trial. Intensive Care Med. 2016 Nov;42(11):1723-1732. doi: 10.1007/s00134-016-4447-8. Epub 2016 Sep 30. |
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Feasibility of the initiation of mechanical ventilation in NAVA mode and feasibility of prolonged mechanical ventilation in NAVA mode
| Continuous recording during the first 48 hours |
| Earnings on the "breathing comfort" | Continuous recording during the first 48 hours |
| Earnings on sleep architecture | Total sleep time; Number of arousals per hour; Duration of stage IV sleep ; Duration of Rapid Eye Movement (REM) sleep. | Continuous recording during the first 48 hours |
| Tolerance |
| Continuous for the duration of ICU stay, an expected maximum of 14 days |
| Continuous recording until extubation or D14 maximum |
| Number of Permanent discontinuation of NAVA ventilation mode | Continuous recording during the first 48 hours |
| Comfort of the device measured by a visual analog scale. | Tolerance of the device | At the extubation or at D14 maximum |
| Side effects associated with the use of the system | Device movements Endotracheal tube obstruction Lesion of the oral or nasal mucosa | Continuous for the duration of ICU stay, an expected maximum of 14 days |
| Lyon |
| Auvergne-Rhône-Alpes |
| 69004 |
| France |
| Centre Hospitalier Lyon Sud | Lyon | Auvergne-Rhône-Alpes | 69495 | France |
| Hopital PELLEGRIN | Bordeaux | Gironde | 33076 | France |
| Groupe Hospitalier Sud - Hôpital Haut-Leveque - Maison du Haut-Leveque | Pessac | Gironde | 33604 | France |
| Hôpital Dupuytren | Limoges | Haute Vienne | 87042 | France |
| Hopital Saint-Eloi - CHU MONTPELLIER | Montpellier | Herault | 34295 | France |
| Hopital Larrey- CHU D'ANGERS | Angers | Maine Et Loire | 49933 | France |
| Hopital de la Cote de Nacre - CHU de CAEN | Caen | Normandy | 14000 | France |
| Hopital d'Estaing | Clermont-Ferrand | Puy de Dome | 63100 | France |
| Hôpital de la Pitié Salpetrière | Paris | Île-de-France Region | 75651 | France |