Chronic Obstructive Pulmonary DiseasePhase 3NCT02289573
Effects of NAVA and PSV to AECOPD Patients' Air Distribution and Dead Space
A Phase 3 study testing NAVA and PSV in people with Chronic Obstructive Pulmonary Disease, run by Southeast University, China.
Trial summary
Chronic obstructive pulmonary disease(COPD) is a common disease among people. Acute exacerbation of chronic obstructive pulmonary disease(AECOPD) is the acute and aggravating phase of COPD which may lead to respiratory failure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- NAVA and PSV
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jun 2015
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AECOPD patients who need invasive mechanical ventilation
- Patients who can tolerate assist mechanical ventilation
- Patients who have signed ICF
Who cannot join
- Patients who are younger than 18 years old or older than 75 years old
- Patients whose respiratory center is severely inhibited
- Patients who can not stand NAVA gastric tube
- Patients who have coagulation disorders
- Patients whose vital signs are unstable
- Patients who are in other clinical trails
About this study
Chronic obstructive pulmonary disease(COPD) is a common disease among people. Acute exacerbation of chronic obstructive pulmonary disease(AECOPD) is the acute and aggravating phase of COPD which may lead to respiratory failure. Mechanical ventilation is a very important therapy for those patients,but traditional ventilation modes have some defects, so investigators need to find new modes to solve these problems. In this study, the investigators compare neurally adjusted ventilatory assist (NAVA) and PSV to observe the effects on AECOPD patients' air distribution and dead space to determine if NAVA is a more appropriate ventilation mode for AECOPD patients.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- NAVA and PSV
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVA and PSVDevice
change ventilation modes(NAVA and PSV) with different support levels
| Study group | Role | What they receive |
|---|---|---|
| neurally adjusted ventilatory assist | Experimental | Not described Receives: Device: NAVA and PSV |
| pressure support ventilation | Sham comparator | Not described Receives: Device: NAVA and PSV |
What is being measured
The primary outcome is the main question the study is designed to answer.
the ratio of physiologic dead space over tidal volume (VD/VT)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Xie, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289573
- Sponsor's protocol ID
- 2014ZDSYLL086.0
- Status last verified
- Oct 2014
- First submitted
- 16 Oct 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sun Q, Liu L, Pan C, Zhao Z, Xu J, Liu A, Qiu H. Effects of neurally adjusted ventilatory assist on air distribution and dead space in patients with acute exacerbation of chronic obstructive pulmonary disease. Crit Care. 2017 Jun 2;21(1):126. doi: 10.1186/s13054-017-1714-1.
PubMed 28578708
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of NAVA and PSV to AECOPD Patients' Air Distribution and Dead Space
- ClinicalTrials.gov ID
- NCT02289573
- Acronym / sponsor ID
- 2014ZDSYLL086.0
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 13 Nov 2014 (estimated)
- 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.
Chronic obstructive pulmonary disease(COPD) is a common disease among people. Acute exacerbation of chronic obstructive pulmonary disease(AECOPD) is the acute and aggravating phase of COPD which may lead to respiratory failure. Mechanical ventilation is a very important therapy for those patients,but traditional ventilation modes have some defects, so investigators need to find new modes to solve these problems. In this study, the investigators compare neurally adjusted ventilatory assist (NAVA) and PSV to observe the effects on AECOPD patients' air distribution and dead space to determine if NAVA is a more appropriate ventilation mode for AECOPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neurally adjusted ventilatory assist | Experimental | Device: NAVA and PSV |
| pressure support ventilation | Sham comparator | Device: NAVA and PSV |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AECOPD patients who need invasive mechanical ventilation
- Patients who can tolerate assist mechanical ventilation
- Patients who have signed ICF
Key exclusion criteria (6 listed)
- Patients who are younger than 18 years old or older than 75 years old
- Patients whose respiratory center is severely inhibited
- Patients who can not stand NAVA gastric tube
- Patients who have coagulation disorders
- Patients whose vital signs are unstable
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 |
|---|---|---|
| NAVA and PSVchange ventilation modes(NAVA and PSV) with different support levels | Device | neurally adjusted ventilatory assist, pressure support ventilation |
Primary outcome
the ratio of physiologic dead space over tidal volume (VD/VT)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Derived from this study: PubMed 28578708Sun Q, Liu L, Pan C, Zhao Z, Xu J, Liu A, Qiu H. Effects of neurally adjusted ventilatory assist on air distribution and dead space in patients with acute exacerbation of chronic obstructive pulmonary disease. Crit Care. 2017 Jun 2;21(1):126. doi: 10.1186/s13054-017-1714-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NAVA and PSV in people with Chronic Obstructive Pulmonary Disease, run by Southeast University, 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 ratio of physiologic dead space over tidal volume (VD/VT) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02289573, which also lists 1 linked publication.
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 13 Nov 2014; AzTrials last refreshed its copy on 8 Nov 2026.