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Comparative Effects of Different Noninvasive Ventilation Mode on Neural Respiratory Drive in Recovering AECOPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
noninvasive positive pressure ventilation
Sponsored by
The First Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Neural respiratory drive in different level of NPPV

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • TheFirst Affiliated Hospital Of Guangzhou Medical Collage

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Effect of different NPPV mode on NRD

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

change of the pressure-time product(PTP)
The pressure-time product(PTP)means inspiratory effort of the inspiratory muscle In COPD lung mechanical abnormality including airflow obstruction and dynamic hyperinflation and intrinsic positive end-expiratory pressure increase the work load of the respiratory muscles,which will lead to higher inspiratory work. As a result,The efficiency of neural respiratory drive as expressed as a ratio of minute ventilation to diaphragm electromyogram (EMGdi) in patients with COPD is lower than that in healthy subject.This study want to investigate the effect of noninvasive positive pressure ventilation(NPPV)on the inspiratory muscle load of the COPD patients

Full Information

First Posted
January 19, 2013
Last Updated
December 3, 2016
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01782768
Brief Title
Comparative Effects of Different Noninvasive Ventilation Mode on Neural Respiratory Drive in Recovering AECOPD Patients
Official Title
Comparative Effects of Noninvasive Proportional Assist and Pressure Support Ventilation on Neural Respiratory Drive in Recovering Acute Exacerbation of Chronic Obstructive Pulmonary Disease(AECOPD) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Methods: After the baseline data of spontaneous breathing was collected, 20 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. The respiratory frequency (RR), tidal volume (VT), transdiaphragmatic pressure (pdi) the pressure-time product (PTP) and root-mean-square(RMS) of EMGdi were calculated. Esophageal and gastric balloon-catheters were used to detect the intra-thoracic and abdominal pressure. Airway pressure was also measured simultaneously. EMGdi was recorded from a multipair esophageal electrode .During ventilation Airflow and ventilation were measured with pneumotachograph.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Neural respiratory drive in different level of NPPV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Effect of different NPPV mode on NRD
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
noninvasive positive pressure ventilation
Intervention Description
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
Primary Outcome Measure Information:
Title
change of the Neural respiratory drive
Description
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
Time Frame
15-20 minute
Secondary Outcome Measure Information:
Title
change of the pressure-time product(PTP)
Description
The pressure-time product(PTP)means inspiratory effort of the inspiratory muscle In COPD lung mechanical abnormality including airflow obstruction and dynamic hyperinflation and intrinsic positive end-expiratory pressure increase the work load of the respiratory muscles,which will lead to higher inspiratory work. As a result,The efficiency of neural respiratory drive as expressed as a ratio of minute ventilation to diaphragm electromyogram (EMGdi) in patients with COPD is lower than that in healthy subject.This study want to investigate the effect of noninvasive positive pressure ventilation(NPPV)on the inspiratory muscle load of the COPD patients
Time Frame
15-20 minute

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of the COPD (Chronic Obstructive Pulmonary Disease) the COPD patients were all in stable condition during recovery from acute exacerbation. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
rong chang chen, professor
Organizational Affiliation
TheFirst Affiliated Hospital Of Guangzhou Medical Collage
Official's Role
Study Director
Facility Information:
Facility Name
TheFirst Affiliated Hospital Of Guangzhou Medical Collage
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31551283
Citation
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.
Results Reference
derived

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Comparative Effects of Different Noninvasive Ventilation Mode on Neural Respiratory Drive in Recovering AECOPD Patients

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