Effect of Nava on Weaning Outcome in Patients With Mechanical Ventilation

NCT05219643 | Completed DMC

• 1 other identifier: NAVA2021
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

ARDS

Keywords

NAVA; Weaning; Tracheotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Weaning Success Rate

  From enrollment to days 28

• Duration of Mechanical Ventilation

  From enrollment to days 28.

• 28-ICU mortality

  From enrollment to days 28.

Study Arms (2)

NAVA

EXPERIMENTAL

Received NAVA.

Device: NAVA

PSV

ACTIVE COMPARATOR

Received PSV.

Device: PSV

Interventions

NAVA 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.

NAVA

PSV 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.

PSV

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Southeast University, China: lead
• First Affiliated Hospital of Wannan Medical College: collaborator

Study Sites (2)

Yijishan Hospital, The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, 241001, China

Location

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

Location

Study Officials

• Liu Ling, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: January 26, 2022
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)