Skip to main content
OpenTrials
Completed

NCT Number: NCT01280773

Effect of NAVA on Weaning Duration in Difficult to Wean Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Zhong-Da Hospital

Nanjing, Jiangsu, 210009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

NAVA

Device

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 outcomes

  1. Duration of weaning

    Time frame: 48h after extubation

    Duration of weaning was defined as time from study enrollment to extubation.

Secondary outcomes

  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 outcomes

  1. Mortality

    Time frame: ICU or hospital discharge or 28day

    ICU, 28 day and hospital mortality

Sponsors and collaborators

Lead sponsor

Ling Liu

Other

Collaborators

  • Unity Health Toronto

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
Jan 21, 2011
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.