Effect of Nava on Weaning Outcome in Patients With Mechanical Ventilation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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。
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NAVA Received NAVA. |
Device: NAVA
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.
|
| Active Comparator: PSV Received PSV. |
Device: PSV
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.
|
Outcome Measures
Primary Outcome Measures
- The 28-day ventilator-free days [From enrollment to days 28]
Days alive and free from mechanical ventilation from study drug administration to day 28.
Secondary Outcome Measures
- Weaning Success Rate [From enrollment to days 28]
Respective groups weaning Success Rate
- Duration of Mechanical Ventilation [From enrollment to days 28.]
Duration of mechanical ventilation within 28 days after enrollment
- 28-ICU mortality [From enrollment to days 28.]
ICU mortality within 28 days after enrollment
Eligibility Criteria
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;
-
Failing to sign the informed consent form;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongda Hospital | Nanjing | Jiangsu | China | 210009 |
Sponsors and Collaborators
- Southeast University, China
- First Affiliated Hospital of Wannan Medical College
Investigators
- Principal Investigator: Liu Ling, MD, Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NAVA2021