Effect of Neurally-Adjusted Ventilatory Assist (NAVA) on Weaning Outcome in Patients With Mechanical Ventilation: Multicenter, Single-blind, Parallel, Control, Randomized Clinical Trials
Overview
- Phase
- N/A
- Intervention
- NAVA
- Conditions
- ARDS
- Sponsor
- Southeast University, China
- Enrollment
- 130
- Locations
- 3
- Primary Endpoint
- The 28-day ventilator-free days
- Status
- Completed
- Last Updated
- 3 days ago
Overview
Brief Summary
This study intends to compare the effects of NAVA and PSV on weaning success rate and mechanical ventilation time in patients with tracheotomy patients through a randomized controlled study.
Detailed Description
For patients with difficult weaning, NAVA can shorten the time of mechanical ventilation, but there is no large-scale study to explore the effect of NAVA on the weaning success rate and mechanical ventilation time of patients with gas resection. Therefore, this study intends to compare the effects of NAVA and PSV on weaning success rate and mechanical ventilation time in patients with tracheotomy patients through a randomized controlled study. It is a prospective, multicenter, parallel group, single blind, randomized controlled tria。
Investigators
Ling Liu
professor
Southeast University, China
Eligibility Criteria
Inclusion Criteria
- •Tracheotomy and invasive mechanical ventilation is expected to be required for \> 48h;
- •When support pressure ≤ 15 cmH2O, it can withstand pressure support ventilation (PSV) time \> 1h;
Exclusion Criteria
- •Age \< 18 years or \> 85 years;
- •Deep sedation.
- •Severe hemodynamic instability (norepinephrine or equivalent converted dose of other vasoactive drugs \> 1ug / kg.min or map ≤ 65mmhg)
- •Severe respiratory center depression, high paraplegia, neuromuscular disease;
- •Esophageal obstruction, esophageal perforation, severe esophageal variceal bleeding, upper gastrointestinal surgery, diaphragmatic hernia and thoracic deformity;
- •Patients with chronic respiratory diseases requiring long-term home oxygen therapy;
- •Patients with severe coagulation dysfunction (INR \> 1.5, APTT \> 44s, history of leukemia);
- •Severe other organ dysfunction is expected to die in a short time (7 days) or palliative treatment.
- •The estimated survival time of advanced solid organ or hematological system tumors is \< 30 days
- •Participate in other clinical studies within 30 days;
Arms & Interventions
NAVA
Received NAVA.
Intervention: NAVA
PSV
Received PSV.
Intervention: PSV
Outcomes
Primary Outcomes
The 28-day ventilator-free days
Time Frame: From enrollment to days 28
Days alive and free from mechanical ventilation from study drug administration to day 28.
Secondary Outcomes
- 28-ICU mortality(From enrollment to days 28.)
- Duration of Mechanical Ventilation(From enrollment to days 28.)
- Weaning Success Rate(From enrollment to days 28)