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NCT Number: NCT05219643

Effect of Nava on Weaning Outcome in Patients With Mechanical Ventilation

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.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yijishan Hospital, The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China

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About this study

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。

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

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.

Primary outcomes

  1. The 28-day ventilator-free days

    Time frame: From enrollment to days 28

    Days alive and free from mechanical ventilation from study drug administration to day 28.

Secondary outcomes

  1. Weaning Success Rate

    Time frame: From enrollment to days 28

    Respective groups weaning Success Rate

  2. Duration of Mechanical Ventilation

    Time frame: From enrollment to days 28.

    Duration of mechanical ventilation within 28 days after enrollment

  3. 28-ICU mortality

    Time frame: From enrollment to days 28.

    ICU mortality within 28 days after enrollment

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Collaborators

  • First Affiliated Hospital of Wannan Medical College

Registry information

Official study title

Effect of Neurally-Adjusted Ventilatory Assist (NAVA) on Weaning Outcome in Patients With Mechanical Ventilation: Multicenter, Single-blind, Parallel, Control, Randomized Clinical Trials

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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