Effect of Nava on Weaning Outcome in Patients With Mechanical Ventilation

NCT ID: NCT05219643

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-15
• Study Completion Date: 2025-02-27

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。

Conditions

ARDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NAVA

Received NAVA.

Group Type: EXPERIMENTAL

NAVA

Intervention Type: DEVICE

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.

PSV

Received PSV.

Group Type: ACTIVE_COMPARATOR

PSV

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Wannan Medical College

OTHER

Sponsor Role: collaborator

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Ling Liu

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liu Ling, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University

Locations

Zhongda Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

NAVA2021

Identifier Type: -

Identifier Source: org_study_id