Clinical trial NCT05219643: Effect of Nava on Weaning Outcome in Patients With Mechanical Ventilation
Official title: Effect of Neurally-Adjusted Ventilatory Assist (NAVA) on Weaning Outcome in Patients With Mechanical Ventilation: Multicenter, Single-blind, Parallel, Control, Randomized Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS
Keywords: NAVA
Weaning
Tracheotomy
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Wannan Medical College
First posted: 2022-02-02
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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。

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;

Primary outcomes:
measure: The 28-day ventilator-free days
timeFrame: From enrollment to days 28
Secondary outcomes:
measure: Weaning Success Rate
timeFrame: From enrollment to days 28
measure: Duration of Mechanical Ventilation
timeFrame: From enrollment to days 28.
measure: 28-ICU mortality
timeFrame: From enrollment to days 28.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
name: Liu Ling, MD
role: PRINCIPAL_INVESTIGATOR
References: