Effects of NAVA and PSV to AECOPD Patients' Air Distribution and Dead Space
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
NAVA and PSV
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- AECOPD patients who need invasive mechanical ventilation
- Patients who can tolerate assist mechanical ventilation
- Patients who have signed ICF
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
neurally adjusted ventilatory assist
pressure support ventilation
Arm Description
Outcomes
Primary Outcome Measures
the ratio of physiologic dead space over tidal volume (VD/VT)
Secondary Outcome Measures
Full Information
NCT ID
NCT02289573
First Posted
October 16, 2014
Last Updated
November 12, 2014
Sponsor
Southeast University, China
1. Study Identification
Unique Protocol Identification Number
NCT02289573
Brief Title
Effects of NAVA and PSV to AECOPD Patients' Air Distribution and Dead Space
Official Title
Effects of NAVA and PSV to AECOPD Patients' Air Distribution and Dead Space
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
neurally adjusted ventilatory assist
Arm Type
Experimental
Arm Title
pressure support ventilation
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
NAVA and PSV
Intervention Description
change ventilation modes(NAVA and PSV) with different support levels
Primary Outcome Measure Information:
Title
the ratio of physiologic dead space over tidal volume (VD/VT)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
AECOPD patients who need invasive mechanical ventilation
Patients who can tolerate assist mechanical ventilation
Patients who have signed ICF
Exclusion Criteria:
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
28578708
Citation
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.
Results Reference
derived
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Effects of NAVA and PSV to AECOPD Patients' Air Distribution and Dead Space
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