Effect of Nava on Weaning Outcome in Patients With Mechanical Ventilation

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

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.

Study Overview

• Status: Recruiting
• Conditions: ARDS
• Intervention / Treatment: Device: NAVA; Device: PSV

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。

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liu Ling, MD; Phone Number: 86-25-83262552; Email: liulingdoctor@126.com
• Study Contact Backup: Name: Yang Yi, MD; Phone Number: 86-25-83262552; Email: yiyiyang2004@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital
      • Contact: Ling Liu, Dr; Phone Number: +8613851435472; Email: liulingdoctor@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NAVA; Received NAVA.	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.
Active Comparator: PSV; Received PSV.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weaning Success Rate	Respective groups weaning Success Rate	From enrollment to days 28
Duration of Mechanical Ventilation	Duration of mechanical ventilation within 28 days after enrollment	From enrollment to days 28.
28-ICU mortality	ICU mortality within 28 days after enrollment	From enrollment to days 28.

Collaborators and Investigators

• Sponsor: Southeast University, China
• Collaborators: First Affiliated Hospital of Wannan Medical College
• Investigators: Principal Investigator: Liu Ling, MD, Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): October 15, 2023

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Weaning; NAVA; Tracheotomy
• Other Study ID Numbers: NAVA2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No