NCT02289573

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_3 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_3 chronic-obstructive-pulmonary-disease

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2014

Completed
16 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 13, 2014

Status Verified

October 1, 2014

Enrollment Period

7 months

First QC Date

October 16, 2014

Last Update Submit

November 12, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • the ratio of physiologic dead space over tidal volume (VD/VT)

    1 year

Study Arms (2)

neurally adjusted ventilatory assist

EXPERIMENTAL
Device: NAVA and PSV

pressure support ventilation

SHAM COMPARATOR
Device: NAVA and PSV

Interventions

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

neurally adjusted ventilatory assistpressure support ventilation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AECOPD patients who need invasive mechanical ventilation
  • Patients who can tolerate assist mechanical ventilation
  • Patients who have signed ICF

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 16, 2014

First Posted

November 13, 2014

Study Start

November 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 13, 2014

Record last verified: 2014-10