ARDSNCT05219643
Effect of Nava on Weaning Outcome in Patients With Mechanical Ventilation
A study testing NAVA and PSV in people with ARDS, run by Southeast University, China at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ARDS
- What is being tested?
- NAVA and PSV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesChina
- Study dates
- 26 Jan 2022to 27 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
2 sites in 1 country.
China2 sites
Zhongda Hospital
Nanjing, Jiangsu, 210009
Yijishan Hospital, The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001
About this study
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
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.
Read the 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。
- Conditions
- ARDS
- Being tested
- NAVA, PSV
- Keywords
- NAVA, Weaning, Tracheotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVADevice
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.
PSVDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| NAVA | Experimental | Received NAVA. Receives: Device: NAVA |
| PSV | Active comparator | Received PSV. Receives: Device: PSV |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 28-day ventilator-free days
Days alive and free from mechanical ventilation from study drug administration to day 28.
Measured: From enrollment to days 28
Secondary outcomes (3)
Weaning Success Rate
Respective groups weaning Success Rate
Measured: From enrollment to days 28
Duration of Mechanical Ventilation
Duration of mechanical ventilation within 28 days after enrollment
Measured: From enrollment to days 28.
28-ICU mortality
ICU mortality within 28 days after enrollment
Measured: From enrollment to days 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start26 Jan 2022
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Wannan Medical College
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- Liu Ling, MD, Principal investigator, Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219643
- Sponsor's protocol ID
- NAVA2021
- Status last verified
- Apr 2026
- First submitted
- 21 Jan 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05219643
- Acronym / sponsor ID
- NAVA2021
- Conditions
- ARDS
- Keywords
- NAVA, Weaning, Tracheotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Wannan Medical College
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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。
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAVA | Experimental | Device: NAVAReceived NAVA. |
| PSV | Active comparator | Device: PSVReceived PSV. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAVANava 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. | Device | NAVA |
| PSVAccording 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. | Device | PSV |
Primary outcome
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.
3 secondary outcomes
Weaning Success Rate
Time frame: From enrollment to days 28
Duration of Mechanical Ventilation
Time frame: From enrollment to days 28.
28-ICU mortality
Time frame: From enrollment to days 28.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liu Ling, MD principal investigator
Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVA and PSV in people with ARDS, run by Southeast University, China at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 28-day ventilator-free days (time frame: From enrollment to days 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.