Effect of NAVA on Weaning Duration in Difficult to Wean Patients

NCT01280773 | Completed DMC

• 1 other identifier: 437129518
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Weaning

Keywords

weaning, mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Duration of weaning

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

  48h after extubation

Secondary Outcomes (3)

• Extubation rate

  48h after extubation or 30 day after enrollment

• diaphragmatic function

  At 8 am daily before extubatiuon

• Patient ventilator asynchrony

  At 8 am daily until extubation

Other Outcomes (1)

• Mortality

  ICU or hospital discharge or 28day

Study Arms (2)

PSV weaning

NO INTERVENTION

Patinens in the PSV group will be weaned using PSV mode.

NAVA weaning

EXPERIMENTAL

Patients in NAVA group will eb weaned using NAVA mode.

Device: NAVA

Interventions

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.

NAVA weaning

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ling Liu: lead
• Unity Health Toronto: collaborator

Study Sites (1)

Nanjing Zhong-Da Hospital

Nanjing, Jiangsu, 210009, China

Location

Study Officials

• Haibo Qiu, PhD,MD

  Southeast University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: January 21, 2011
• Study Start: September 30, 2011
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

CN (1)