Effects of NAVA and PSV to AECOPD Patients' Air Distribut... | NCT02289573

Studies
Effects of NAVA and PSV to AECOPD Patients' Air Distribution and Dead Space

NCT02289573

Sponsor

Southeast University, China

Status

Unknown status

Last Update Posted

Nov 13, 2014Estimated

Enrollment

15Estimated

Phase

Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

NAVA and PSV

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Jun 2015Estimated

Completion Date

Jun 2015Estimated

First Submitted Date

Oct 16, 2014

First Submission Date that Met QC Criteria

Nov 12, 2014

First Posted Date

Nov 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2014

Last Update Posted Date

Nov 13, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
neurally adjusted ventilatory assist	Experimental		Device: NAVA and PSV
pressure support ventilation	Sham Comparator		Device: NAVA and PSV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NAVA and PSV	Device	change ventilation modes(NAVA and PSV) with different support levels	neurally adjusted ventilatory assist pressure support ventilation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the ratio of physiologic dead space over tidal volume (VD/VT)		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28578708	Derived	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.

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease