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| Name | Class |
|---|---|
| Hospital Universitario de Gran Canaria Doctor Negrín | OTHER |
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The purpose of this study is to compare a specific mode of artificial ventilation (help from a breathing machine) with other modes. This specific mode is called Neurally Adjusted Ventilatory Assist (NAVA) and is different from other modes as it uses direct signals from the diaphragm (breathing muscle) to help patients breathe. The investigators believe that using these signals, NAVA can determine the exact timing for patients' spontaneous breathing effort and delivers the artificial breath at the same time (in synchrony) with their own breath. Other modes (breathing methods) may cause asynchrony between the patient and the ventilator while delivering artificial breaths because of the way they operate. Asyncrony between patient and ventilator is a risk factor for increasing the length of artificial ventilation and number of related complications. The investigators would like to find out if NAVA performs better in establishing synchrony between patient and ventilator and as a result decreasing time for artificial ventilation and increasing better outcomes.
Study Goal To compare the ability of NAVA vs. conventional lung protective ventilation in a multicenter, unblinded, randomized, controlled fashion to provide invasive ventilatory support during acute respiratory failure in adults who are expected to require ventilatory support for greater than 72 hours.
Hypothesis It is hypothesized that the use of NAVA compared to conventional lung protective ventilation will result in a decrease in the number of days of mechanical ventilation. It is further hypothesized that NAVA compared to conventional lung protective ventilation will result in a decrease in the length of weaning, the length of ICU and hospital stay, and mortality.
Primary Outcome
• Number of invasive ventilator free days.
Secondary Outcome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Lung Protective Ventilation | Other | In this group, patients will be ventilated in either volume A/C, pressure A/C, pressure support, pressure regulated volume control or volume support based on the discretion of the medical team with TV 4-8 ml/kg PBW range and PP or pressure (control or support) level <30 cmH2O. |
|
| NAVA Ventilation Group | Other | In the NAVA group, NAVA level will be set initially at zero, then the maximum Edi will be determined as the average level over the next 3 to 5 breaths without ventilatory support or PEEP. The actual NAVA level will then be titrated by the clinician to achieve the following: 1) an Edi equal to approximately 50% of the maximum Edi, 2) an average tidal volume of between 4 to 8 ml/kg predicted body weight (PBW), and 3) an average respiratory rate between about 15 and 40 per minute. In addition, the trigger sensitivity should be set as sensitive as possible without causing auto-triggering and the maximum pressure limit in NAVA should be set at 40 cm H2O. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAVA ventilation | Other | Neurally adjusted ventilatory assist |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of invasive ventilator free days. | Number of days without mechanical ventilation, within the first 28 days of the study. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total length of mechanical ventilation in survivors (invasive plus noninvasive) | Total number of days of mechanical ventilation in ICU survivors. | 90 days |
| ICU and hospital Mortality | Mortality during patient stay in the ICU and after being discharged from ICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert M Kacmarek, PhD | Massachusetts General Hospital | Principal Investigator |
| Jesus Villar, MD, PhD | Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Zhongda Hospital Southeast University | Nanjing | China | ||||
| Hospital Universitario NS de Candelaria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27737690 | Derived | Villar J, Belda J, Blanco J, Suarez-Sipmann F, Anon JM, Perez-Mendez L, Ferrando C, Parrilla D, Montiel R, Corpas R, Gonzalez-Higueras E, Pestana D, Martinez D, Fernandez L, Soro M, Garcia-Bello MA, Fernandez RL, Kacmarek RM; NAVa In Acute respiraTORy failure (NAVIATOR) Network. Neurally adjusted ventilatory assist in patients with acute respiratory failure: study protocol for a randomized controlled trial. Trials. 2016 Oct 13;17(1):500. doi: 10.1186/s13063-016-1625-5. |
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| Conventional Lung Protective Ventilation |
| Other |
conventional protective mechanical ventilation |
|
| 90 days |
| Incidence of barotrauma | Number of diagnosed pneumothorax | 60 Days |
| Ventilator associated pneumonia | Number of diagnosed Ventilator Associated Pneumonia | 60 Days |
| Development of Acute respiratory distress syndrome (ARDS) | Number of patients developing ARDS | 60 Days |
| Length of ICU stay | Total number of days of ICU stay. | 90 Days |
| Length of hospital stay | Total number of days of Hospital stay. | 90 Days |
| Santa Cruz de Tenerife |
| Tenerife |
| 38010 |
| Spain |
| Hospital NS del Prado | Talavera de la Reina | Toledo | 45600 | Spain |
| Complejo Hospitalario Universitario de Albacete | Albacete | 02006 | Spain |
| Hospital Virgen de la Luz | Cuenca | 16002 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Morales Meseguer | Murcia | 30008 | Spain |
| Hospital Universitario Virgen de Arrixaca | Murcia | 30120 | Spain |
| Hospital Virgen de la Salud | Toledo | 45004 | Spain |
| Hospital Clinico de Valencia | Valencia | Spain |
| Hospital Universitario Rio Hortega | Valladolid | 47012 | Spain |
| Hospital Txagorritxu | Vitoria-Gasteiz | Álava | 01007 | Spain |