Text Size

Effect of NAVA on Duration of Weaning in Difficult to Wean Patients

This study is currently recruiting participants.
Verified August 2012 by Southeast University, China
Sponsor:
Collaborator:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Ling Liu, Southeast University, China
ClinicalTrials.gov Identifier:
NCT01280773
First received: December 28, 2010
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  Purpose

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. 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 Intervention
Weaning
 Device: Neurally adjusted ventilatory assist

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Critical Care
U.S. FDA Resources

Further study details as provided by Southeast University, China:

Primary Outcome Measures:
  • Duration of weaning [ Time Frame: 48h after extubation ] [ Designated as safety issue: No ]
    duration of weaning was defined as time from study enrollment to extubation.


Secondary Outcome Measures:
  • Extubation rate [ Time Frame: 48h after extubation or 30 day after enrollment ] [ Designated as safety issue: No ]
    Extubation rate was defined as the percentage of patients with successful weaning.

  • diaphragmatic function [ Time Frame: At 8 am daily before extubatiuon ] [ Designated as safety issue: No ]
    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.

  • Patient ventilator asynchrony [ Time Frame: At 8 am daily until extubation ] [ Designated as safety issue: No ]
    Time delay between neuro inspiration and ventilator delivery. Time delay between neuro expiration and ventilator cycle-off.


Estimated Enrollment: 50
Study Start Date: December 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Neurally adjusted ventilatory assist
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.
Other Name: NAVA

Detailed Description:

Intubated patients who were deemed ready for extubation 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 ( neurally adjusted ventilatory assist) 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. in both group, 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 frist 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 reintubated, 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 hrs before the measurement of diaphragmatic function and SBT. Main end point wast the duration of weaning, and second end point was extubation rate, diaphragmatic function and patient ventilator asynchrony.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Intubated patients who were deemed ready for extubation 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280773

Locations
China, Jiangsu
Nanjing Zhong-Da Hospital Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Ling Liu, MD.     86-25-83272201     liuling6600@yahoo.com.cn    
Contact: Haibo Qiu, PhD.,MD.     86-25-83272200     haiboq2000@yahoo.com.cn    
Principal Investigator: Ling Liu, MD.            
Principal Investigator: Lanqi Guo, MD.            
Sponsors and Collaborators
Ling Liu
St. Michael's Hospital, Toronto
Investigators
Study Director: Haibo Qiu, PhD,MD Southeast University
  More Information

No publications provided

Responsible Party: Ling Liu, professor, Southeast University, China
ClinicalTrials.gov Identifier: NCT01280773     History of Changes
Other Study ID Numbers: 437129518
Study First Received: December 28, 2010
Last Updated: August 9, 2012
Health Authority: China: Ethics Committee

Keywords provided by Southeast University, China:
weaning, mechanical ventilation

ClinicalTrials.gov processed this record on May 19, 2013