NCT01782768

Brief Summary

Background: The efficiency of Neural respiratory drive (NRD)expressed by a ratio of ventilation to the diaphragm electromyogram (EMGdi) decreases in patients with COPD .Improving the neural respiratory drive efficiency of COPD will help to relieve the clinical symptom and make the patients feel comfort.Noninvasive positive pressure ventilation(NPPV)is a good treatment to AECOPD patients.It is unknown the effects of different mode of noninvasive positive pressure ventilation(NPPV) such as proportional assist ventilation (PAV) and pressure-support ventilation (PSV) on the efficiency of Neural drive of AECOPD and which mode benefit the patients more. Objective: To compare the short-term effects of mask pressure support ventilation (PSV) and proportional assist ventilation (PAV) on Neural respiratory drive in recovering patients of AECOPD

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

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

Timeline
Completed

Started Jan 2013

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

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

3 months

First QC Date

January 19, 2013

Last Update Submit

December 3, 2016

Conditions

Keywords

Neural respiratory drive in different level of NPPV

Outcome Measures

Primary Outcomes (1)

  • change of the Neural respiratory drive

    In recent studies, The efficiency of neural respiratory drive(NRD) as expressed as a ratio of minute ventilation to diaphragm electromyogram (EMGdi) in patients with COPD is lower than that in healthy subject, suggesting that, to achieve the same minute ventilatory volume, a higher neural drive is required for patients with COPD than for healthy individuals.Furthermore,levels of neural respiratory drive were related to disease severity and dyspnea.Improving the neural respiratory drive efficiency of COPD will help to relieve the clinical symptom and make the patients feel comfort. Because dyspnea relates to respiratory effort.Neural respiratory drive(NRD) and its efficiency as expressed by a ratio of ventilation to the diaphragm electromyogram(EMGdi)may be a good tool to evaluate treatment benefits in Patients with COPD.This study want to investigate the effect of noninvasive positive pressure ventilation(NPPV)on the Neural respiratory drive of COPD patients

    15-20 minute

Secondary Outcomes (1)

  • change of the pressure-time product(PTP)

    15-20 minute

Study Arms (1)

Effect of different NPPV mode on NRD

EXPERIMENTAL

13 hypercapnic recovering AECOPD patients were placed on different mode of noninvasive positive pressure ventilation(NPPV,such as the PAV or PSV mode) randomly.For each mode, three levels (PA-, PA, PA+or PS-, PS, PS+), ) of support were applied.PS and PA are set for the patient's comfort . On the basis of these two levels, 25% increase and reduction assisted level of pressure were set both for PS and PA (PA-, PA+or PS-, PS+). At each level, the patients were ventilated at least 20 minutes until the breathing was stable.

Device: noninvasive positive pressure ventilation

Interventions

the assisted level of the noninvasive proportional assist(PAV) and pressure support ventilation(PSV) on Neural respiratory drive(NRD) in recovering patients with acute exacerbation of chronic obstructive pulmonary disease

Effect of different NPPV mode on NRD

Eligibility Criteria

Age50 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of the COPD (Chronic Obstructive Pulmonary Disease) the COPD patients were all in stable condition during recovery from acute exacerbation.

You may not qualify if:

  • severe Cardiovascular disease
  • Pneumonia
  • neuromuscular and chest wall deformity
  • Respiratory arrest
  • Cardiovascular instability (hypotension, arrhythmias, myocardial infarction)
  • Change in mental status; uncooperative patient
  • High aspiration risk
  • Viscous or copious secretions
  • Recent facial or gastroesophageal surgery
  • Craniofacial trauma
  • Fixed nasopharyngeal abnormalities
  • Burns
  • Extreme obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TheFirst Affiliated Hospital Of Guangzhou Medical Collage

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

  • Zhang J, Luo Q, Chen R. Patient-Ventilator Interaction With Noninvasive Proportional Assist Ventilation in Subjects With COPD. Respir Care. 2020 Jan;65(1):45-52. doi: 10.4187/respcare.06430. Epub 2019 Sep 24.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • rong chang chen, professor

    TheFirst Affiliated Hospital Of Guangzhou Medical Collage

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
zhang jianheng

Study Record Dates

First Submitted

January 19, 2013

First Posted

February 4, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

December 6, 2016

Record last verified: 2016-12

Locations