Effect of Nava on Weaning Outcome in Patients With Mechanical Ventilation

Not Applicable

Completed

• Conditions: ARDS
• Interventions: Device: PSV; Device: NAVA

• Registration Number: NCT05219643
• Lead Sponsor: Southeast University, China

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。

Study Timeline

• Study Start: 2021-10-15
• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-02-02
• Primary Completion: 2025-02-27
• Study Completion: 2025-02-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. Tracheotomy and invasive mechanical ventilation is expected to be required for > 48h;
2. When support pressure ≤ 15 cmH2O, it can withstand pressure support ventilation (PSV) time > 1h;

Exclusion Criteria

1. Age < 18 years or > 85 years;
2. Deep sedation.
3. Severe hemodynamic instability (norepinephrine or equivalent converted dose of other vasoactive drugs > 1ug / kg.min or map ≤ 65mmhg)
4. Severe respiratory center depression, high paraplegia, neuromuscular disease;
5. Esophageal obstruction, esophageal perforation, severe esophageal variceal bleeding, upper gastrointestinal surgery, diaphragmatic hernia and thoracic deformity;
6. Patients with chronic respiratory diseases requiring long-term home oxygen therapy;
7. Patients with severe coagulation dysfunction (INR > 1.5, APTT > 44s, history of leukemia);
8. Severe other organ dysfunction is expected to die in a short time (7 days) or palliative treatment.
9. The estimated survival time of advanced solid organ or hematological system tumors is < 30 days
10. Participate in other clinical studies within 30 days;
11. Failing to sign the informed consent form;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PSV	PSV	Received PSV.
NAVA	NAVA	Received NAVA.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Weaning Success Rate	From enrollment to days 28	Respective groups weaning Success Rate
28-ICU mortality	From enrollment to days 28.	ICU mortality within 28 days after enrollment
Duration of Mechanical Ventilation	From enrollment to days 28.	Duration of mechanical ventilation within 28 days after enrollment

Trial Locations

Locations (1)

Zhongda Hospital; 🇨🇳 Nanjing, Jiangsu, China