Effect of Nava on Weaning Outcome in Patients With Mechanical Ventilation

Southeast University, China

Status: Completed

Conditions: ARDS

Treatments: Device: PSV; Device: NAVA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05219643

NAVA2021

Details and patient eligibility

About

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.

Full 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。

Enrollment: 130 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

NAVA

Experimental group

Description:

Received NAVA.

Treatment:

Device: NAVA

PSV

Active Comparator group

Description:

Received PSV.

Treatment:

Device: PSV