Back to resultsEffect of Nava on Weaning Outcome in Patients With Mechanical Ventilation
Primary Purpose
ARDS
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NAVA
PSV
Sponsored by
About this trial
This is an interventional treatment trial for ARDS focused on measuring NAVA, Weaning, Tracheotomy
Eligibility Criteria
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;
Sites / Locations
- Zhongda HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NAVA
PSV
Arm Description
Received NAVA.
Received PSV.
Outcomes
Primary Outcome Measures
The 28-day ventilator-free days
Days alive and free from mechanical ventilation from study drug administration to day 28.
Secondary Outcome Measures
Weaning Success Rate
Respective groups weaning Success Rate
Duration of Mechanical Ventilation
Duration of mechanical ventilation within 28 days after enrollment
28-ICU mortality
ICU mortality within 28 days after enrollment
Full Information
NCT ID
NCT05219643
First Posted
January 21, 2022
Last Updated
January 21, 2022
Sponsor
Southeast University, China
Collaborators
First Affiliated Hospital of Wannan Medical College
1. Study Identification
Unique Protocol Identification Number
NCT05219643
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
Collaborators
First Affiliated Hospital of Wannan Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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。
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS
Keywords
NAVA, Weaning, Tracheotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NAVA
Arm Type
Experimental
Arm Description
Received NAVA.
Arm Title
PSV
Arm Type
Active Comparator
Arm Description
Received PSV.
Intervention Type
Device
Intervention Name(s)
NAVA
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PSV
Intervention Description
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 Outcome Measure Information:
Title
The 28-day ventilator-free days
Description
Days alive and free from mechanical ventilation from study drug administration to day 28.
Time Frame
From enrollment to days 28
Secondary Outcome Measure Information:
Title
Weaning Success Rate
Description
Respective groups weaning Success Rate
Time Frame
From enrollment to days 28
Title
Duration of Mechanical Ventilation
Description
Duration of mechanical ventilation within 28 days after enrollment
Time Frame
From enrollment to days 28.
Title
28-ICU mortality
Description
ICU mortality within 28 days after enrollment
Time Frame
From enrollment to days 28.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Ling, MD
Phone
86-25-83262552
Email
liulingdoctor@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Yi, MD
Phone
86-25-83262552
Email
yiyiyang2004@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Ling, MD
Organizational Affiliation
Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongda Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Liu, Dr
Phone
+8613851435472
Email
liulingdoctor@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Nava on Weaning Outcome in Patients With Mechanical Ventilation
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