Weaning Clinical Trial - Effect of NAVA on Weaning Duration in Difficult

Status Completed

Clinical Trial Summary

It has been showed that over assist and patient ventilator asynchrony often occur in mechanical ventilated patients, especially in patients who failed weaning, which are associated with a prolonged duration of mechanical ventilation.Neurally adjusted ventilatory assist (NAVA) improves patient-ventilator synchrony, prevents excessive assist induced diaphragm inactivation. So the aim of this study was to detect that whether NAVA compared with PSV has the ability to reduce the duration of weaning in difficult to wean patients.

Clinical Trial Description

Intubated patients who were deemed ready for weaning by the clinical team but failed the first spontaneous breathing trials (SBT) or weaning were screened for eligibility. After enrollment, nasogastric tube eligible patient was replaced with a modified EAdi catheter. Then the patients were switched to a Servo-i ventilator. According to a random digits table, eligible patients were allocated randomly to ventilation with NAVA or pressure support ventilation (PSV). In PSV group, ventilator settings were determined by the physicians who in charge of the patients, and EAdi signals were not available for ventilator settings. In NAVA group, a daily NAVA level titration was performed to select the NAVA level which got approximate 50% unload, if the patients can't tolerate PSV or NAVA, PCV should be used to insure the ventilation safety. If the patients were under PCV mode, screening should be done by the researchers every 3 hours to make sure whether they will tolerate PSV or NAVA. In both group, daily measurement of diaphragmatic function was performed (only preformed in the first 10 patients of each group), followed by a 30 minutes SBT with PSV 5-7 cmH2O. Patients who were able to tolerate the SBT were extubated. Patients who completed the SBT and remained extubated > 48 h were considered successfully extubated. Patients who failed SBT, or required noninvasive ventilation (NIV), or were re-intubated, or deceased within 48h post-extubation were considered extubation failure. Local sedation protocol including daily wakeup was performed during the research period. All continuous sedative infusions were discontinued at least 1 hour before the measurement of diaphragmatic function and SBT. Main end point was the duration of weaning, and second end point was extubation rate, diaphragmatic function and patient ventilator asynchrony. ;

Study Design

Related Conditions & MeSH terms

Weaning

Clinical Trial Details

NCT number	NCT01280773
Study type	Interventional
Source	Southeast University, China
Contact
Status	Completed
Phase	N/A
Start date	September 30, 2011
Completion date	October 1, 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of NAVA on Weaning Duration in Difficult to Wean Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms