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Effect of NAVA on Weaning Duration in Difficult to Wean Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01280773
Recruitment Status : Completed
First Posted : January 21, 2011
Last Update Posted : October 16, 2018
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Ling Liu, Southeast University, China

Brief 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.

Condition or disease Intervention/treatment Phase
Weaning Device: NAVA Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine, China; Department of Critical Care Medicine St. Michaels's Hospital, University of Toronto, Canada
Actual Study Start Date : September 30, 2011
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : October 1, 2018

Arm Intervention/treatment
No Intervention: PSV weaning
Patinens in the PSV group will be weaned using PSV mode.
Experimental: NAVA weaning
Patients in NAVA group will eb weaned using NAVA mode.
Device: NAVA
Neurally adjusted ventilatory assist (NAVA) was delivered by a SVi ventilator. NAVA utilizes EAdi, a reflection of the neural respiratory output to diaphragm, as its primary source to trigger and cycle-off assist in synchrony with neural inspiratory efforts.

Primary Outcome Measures :
  1. Duration of weaning [ Time Frame: 48h after extubation ]
    Duration of weaning was defined as time from study enrollment to extubation.

Secondary Outcome Measures :
  1. Extubation rate [ Time Frame: 48h after extubation or 30 day after enrollment ]
    Extubation rate was defined as the percentage of patients with successful weaning

  2. diaphragmatic function [ Time Frame: At 8 am daily before extubatiuon ]
    Diaphragmatic function was measured by neuro-ventilatory efficiency (NVE), a ratio of tidal volume to diaphragm electrical activity (Vt/EAdi), and neuro-mechanical efficiency (NME), a ratio of airway pressure to EAdi(Paw/EAdi) during airway occlusion. diaphragmatic function

  3. Patient ventilator asynchrony [ Time Frame: At 8 am daily until extubation ]
    Time delay between neuro inspiration and ventilator delivery. Time delay between neuro expiration and ventilator cycle-off.

Other Outcome Measures:
  1. Mortality [ Time Frame: ICU or hospital discharge or 28day ]
    ICU, 28 day and hospital mortality

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Intubated patients who were deemed ready for weaning by the clinical team but failed the first spontaneous breathing trials (SBT) or weaning

Exclusion Criteria:

  1. age <18 or >80 years,
  2. tracheostomy
  3. treatment abandonment
  4. history of esophageal varices
  5. gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 30 days
  6. coagulation disorders (INR ratio>1.5 and APTT>44 s)
  7. history of acute central or peripheral nervous system disorder or severe neuromuscular disease
  8. history of leukemia, severe chronic liver or chronic cardiac disease
  9. solid organ transplantation
  10. malignant tumor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01280773

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China, Jiangsu
Nanjing Zhong-Da Hospital
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Ling Liu
St. Michael's Hospital, Toronto
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Study Director: Haibo Qiu, PhD,MD Southeast University
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Responsible Party: Ling Liu, professor, Southeast University, China Identifier: NCT01280773    
Other Study ID Numbers: 437129518
First Posted: January 21, 2011    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Keywords provided by Ling Liu, Southeast University, China:
weaning, mechanical ventilation