Chronic Obstructive Pulmonary DiseaseNCT01782768
Comparative Effects of Different Noninvasive Ventilation Mode on Neural Respiratory Drive in Recovering AECOPD Patients
A study testing noninvasive positive pressure ventilation in people with Chronic Obstructive Pulmonary Disease, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- noninvasive positive pressure ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of the COPD (Chronic Obstructive Pulmonary Disease) the COPD patients were all in stable condition during recovery from acute exacerbation.
Who cannot join
- severe Cardiovascular disease
- Pneumonia
- neuromuscular and chest wall deformity
- Respiratory arrest
- Cardiovascular instability (hypotension, arrhythmias, myocardial infarction)
- Change in mental status; uncooperative patient
Show all 13Show fewer
- High aspiration risk
- Viscous or copious secretions
- Recent facial or gastroesophageal surgery
- Craniofacial trauma
- Fixed nasopharyngeal abnormalities
- Burns
- Extreme obesity
Trial locations and contacts
1 site in 1 country.
China1 site
TheFirst Affiliated Hospital Of Guangzhou Medical Collage
Guangzhou, Guangdong, 510000
About this study
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
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
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- noninvasive positive pressure ventilation
- Keywords
- Neural respiratory drive in different level of NPPV
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive positive pressure ventilationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: noninvasive positive pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15-20 minute
Secondary outcomes (1)
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
Measured: 15-20 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Jianheng, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- rong chang chen, professor, Study director, TheFirst Affiliated Hospital Of Guangzhou Medical Collage
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782768
- Sponsor's protocol ID
- zjianheng
- Status last verified
- Dec 2016
- First submitted
- 19 Jan 2013
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31551283
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01782768
- Acronym / sponsor ID
- zjianheng
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Neural respiratory drive in different level of NPPV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effect of different NPPV mode on NRD | Experimental | Device: noninvasive positive pressure ventilation13 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of the COPD (Chronic Obstructive Pulmonary Disease) the COPD patients were all in stable condition during recovery from acute exacerbation.
Key exclusion criteria (13 listed)
- severe Cardiovascular disease
- Pneumonia
- neuromuscular and chest wall deformity
- Respiratory arrest
- Cardiovascular instability (hypotension, arrhythmias, myocardial infarction)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| noninvasive positive pressure ventilationthe 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 | Device | Effect of different NPPV mode on NRD |
Primary outcome
change of the Neural respiratory drive
Time frame: 15-20 minute
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
1 secondary outcome
change of the pressure-time product(PTP)
Time frame: 15-20 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Derived from this study: PubMed 31551283Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
rong chang chen, professor study director
TheFirst Affiliated Hospital Of Guangzhou Medical Collage
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noninvasive positive pressure ventilation in people with Chronic Obstructive Pulmonary Disease, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of the Neural respiratory drive (time frame: 15-20 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01782768, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.