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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02289573
• Other study ID #: 2014ZDSYLL086.0
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 16, 2014
• Last updated: November 12, 2014
• Start date: November 2014
• Est. completion date: June 2015

Study information

• Verified date: October 2014
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• NAVA and PSV
change ventilation modes(NAVA and PSV) with different support levels

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the ratio of physiologic dead space over tidal volume (VD/VT)		1 year	Yes