Effect of Nava on Weaning Outcome in Patients With Mechanical Ventilation

Study Overview
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Brief Summary
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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
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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。

Official Title
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Effect of Neurally-Adjusted Ventilatory Assist (NAVA) on Weaning Outcome in Patients With Mechanical Ventilation: Multicenter, Single-blind, Parallel, Control, Randomized Clinical Trials

Conditions
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ARDS

Intervention / Treatment
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* Device: NAVA
* Device: PSV


Participation Criteria
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Eligibility Criteria
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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; Failing to sign the informed consent form;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAVA<br>Received NAVA. | Device: NAVA<br>* Nava level is set to maintain the target tidal volume: 6-10ml / kg (pbw). The trigger sensitivity is 0.5uv. The expiratory trigger sensitivity: the built-in software of the ventilator is set to 70% of the peak value of diaphragm electrical activity.<br>|
| Active Comparator: PSV<br>Received PSV. | Device: PSV<br>* According to the doctor's experience, maintain the target tidal volume: 6-10ml / kg (pbw); trigger sensitivity: 1.5-2l/min, expiratory trigger sensitivity: 30% inspiratory peak flow rate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 28-day ventilator-free days | Days alive and free from mechanical ventilation from study drug administration to day 28. | From enrollment to days 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaning Success Rate | Respective groups weaning Success Rate | From enrollment to days 28 | 
| Duration of Mechanical Ventilation | Duration of mechanical ventilation within 28 days after enrollment | From enrollment to days 28. | 
| 28-ICU mortality | ICU mortality within 28 days after enrollment | From enrollment to days 28. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAVA, Weaning, Tracheotomy