Effect of Nava on Weaning Outcome in Patients With Mechanical Ventilation

ARDS Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05219643
• Other study ID #: NAVA2021
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: October 15, 2023

Study information

• Verified date: January 2022
• Source: Southeast University, China
• Contact: Liu Ling, MD
• Phone: 86-25-83262552
• Email: liulingdoctor[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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。

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: October 15, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• ARDS

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
China	Zhongda Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Southeast University, China	First Affiliated Hospital of Wannan Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weaning Success Rate	Respective groups weaning Success Rate	From enrollment to days 28
Secondary	Duration of Mechanical Ventilation	Duration of mechanical ventilation within 28 days after enrollment	From enrollment to days 28.
Secondary	28-ICU mortality	ICU mortality within 28 days after enrollment	From enrollment to days 28.