COPDNPPV;COPDNCT03238014
Efficacy of High-intensity NPPV and Low-intensity NPPV in Patients With Chronic Hypercapnic COPD
A study testing Noninvasive positive pressure ventilation in people with COPD and Hypercapnic Respiratory Failure, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
High-intensity noninvasive positive pressure ventilation (NPPV), which can well improve the gas exchange and reduce the work of breathing of patients, is a new strategy targeted at maximally reducing arterial carbon dioxide. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD, Hypercapnic Respiratory Failure
- 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
- 14 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 1 May 2020
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stable with chronic hypercapnic COPD (baseline arterial carbon dioxide pressure (PaCO2) of 50 mmHg or higher, measured resting in a sitting position and breathing room air without having used NPPV for at least 1 hour)
Who cannot join
- other lung/pleural diseases or thoracic deformity
- severe heart failure (New York Heart Association class IV), severe dysrhythmia
- unstable angina, or malignant comorbidity
- obesity (BMI ≥ 35 kg/m²)
- severe obstructive sleep apnea syndrome
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, 510000
Rongchang Chen, +8615622236759, chenrcstatekeylab@gmail.com
About this study
Official title: Efficacy of High-intensity Noninvasive Positive Pressure Ventilation and Low-intensity Noninvasive Positive Pressure Ventilation in Patients With Chronic Hypercapnic Chronic Obstructive Pulmonary Disease
High-intensity noninvasive positive pressure ventilation (NPPV), which can well improve the gas exchange and reduce the work of breathing of patients, is a new strategy targeted at maximally reducing arterial carbon dioxide. However, no definitive conclusions have been drawn to decide whether high-intensity NPPV is the best setting for treating patients with chronic hypercapnic COPD. For now, no unified method for setting up high-pressure NPPV has been established. Most of the trials utilized gradually increased inspiratory positive airway pressure depending on the patient's tolerance. However, from a respiratory physiology point of view, excessive inspiratory positive airway pressure may lead to lung hyperinflation, increased intrinsic positive end expiratory pressures, increased oxygen consumption, and ineffective work of breathing.Therefore, seeking a method to establish individualized high-intensity NPPV is of vital importance.
- Conditions
- COPD, Hypercapnic Respiratory Failure
- Being tested
- Noninvasive positive pressure ventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive positive pressure ventilationDevice
Also called Noninvasive ventilation
Noninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity noninvasive ventilation | Experimental | High-intensity noninvasive positive pressure ventilation aims at maximally improving PaCO2. Receives: Device: Noninvasive positive pressure ventilation |
| Low-intensity noninvasive ventilation | Active comparator | Low-intensity noninvasive positive pressure ventilation is a classic setting of noninvasive ventilation. Receives: Device: Noninvasive positive pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial pressure of arterial blood carbon dioxide (PaCO2)
Daytime arterial blood gas samples were taken with patients resting in a sitting position and breathing room air without having used NPPV for at least 1 hour.
Measured: 12 weeks
Secondary outcomes (6)
Severe Respiratory Insufficiency (SRI) Questionnaire
The SRI Questionnaire has good psychometric properties shown to be valid for chronic hypercapnic COPD patients receiving NPPV. It includes 49 items on seven subscales.
Measured: 12 weeks
Baseline Dyspnea Index/Transition Dyspnea Index
Baseline Dyspnea Index/Transition Dyspnea Index provides a multidimensional measurement of dyspnea based on 3 components that evoke dyspnea in activities of daily living, in symptomatic individuals.
Measured: 12 weeks
Chromic Respiratory Questionnaire
Chromic Respiratory Questionnaire is uesd to measure the health related quality of life in patients with chronic respiratory disease.
Measured: 12 weeks
COPD assessment test
The COPD Assessment Test is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time.
Measured: 12 weeks
Pulmonary function
Pulmonary function tests of lung mechanics - measurements of forced vital capacity, forced expiratory volume in 1 second, forced inspiratory flow rates, etc.
Measured: 12 weeks
6-minute walk test
The 6-minute walk test plays a key role in evaluating functional exercise capacity, assessing prognosis and evaluating response to treatment across a wide range of respiratory diseases.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Aug 2017
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guan Lili, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Rongchang Chen, Study director, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238014
- Sponsor's protocol ID
- GIRD201707
- Acronym
- NPPV;COPD
- Status last verified
- Feb 2020
- First submitted
- 27 Jul 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High-intensity Noninvasive Positive Pressure Ventilation and Low-intensity Noninvasive Positive Pressure Ventilation in Patients With Chronic Hypercapnic Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03238014
- Acronym / sponsor ID
- NPPV;COPD / GIRD201707
- Conditions
- COPD, Hypercapnic Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 3 Aug 2017 (actual)
- 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.
High-intensity noninvasive positive pressure ventilation (NPPV), which can well improve the gas exchange and reduce the work of breathing of patients, is a new strategy targeted at maximally reducing arterial carbon dioxide. However, no definitive conclusions have been drawn to decide whether high-intensity NPPV is the best setting for treating patients with chronic hypercapnic COPD. For now, no unified method for setting up high-pressure NPPV has been established. Most of the trials utilized gradually increased inspiratory positive airway pressure depending on the patient's tolerance. However, from a respiratory physiology point of view, excessive inspiratory positive airway pressure may lead to lung hyperinflation, increased intrinsic positive end expiratory pressures, increased oxygen consumption, and ineffective work of breathing.Therefore, seeking a method to establish individualized high-intensity NPPV is of vital importance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity noninvasive ventilation | Experimental | Device: Noninvasive positive pressure ventilationHigh-intensity noninvasive positive pressure ventilation aims at maximally improving PaCO2. |
| Low-intensity noninvasive ventilation | Active comparator | Device: Noninvasive positive pressure ventilationLow-intensity noninvasive positive pressure ventilation is a classic setting of noninvasive ventilation. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically stable with chronic hypercapnic COPD (baseline arterial carbon dioxide pressure (PaCO2) of 50 mmHg or higher, measured resting in a sitting position and breathing room air without having used NPPV for at least 1 hour)
Key exclusion criteria (5 listed)
- other lung/pleural diseases or thoracic deformity
- severe heart failure (New York Heart Association class IV), severe dysrhythmia
- unstable angina, or malignant comorbidity
- obesity (BMI ≥ 35 kg/m²)
- severe obstructive sleep apnea syndrome
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 ventilationAlso: Noninvasive ventilationNoninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease. | Device | High-intensity noninvasive ventilation, Low-intensity noninvasive ventilation |
Primary outcome
Partial pressure of arterial blood carbon dioxide (PaCO2)
Time frame: 12 weeks
Daytime arterial blood gas samples were taken with patients resting in a sitting position and breathing room air without having used NPPV for at least 1 hour.
6 secondary outcomes
Severe Respiratory Insufficiency (SRI) Questionnaire
Time frame: 12 weeks
Baseline Dyspnea Index/Transition Dyspnea Index
Time frame: 12 weeks
Chromic Respiratory Questionnaire
Time frame: 12 weeks
COPD assessment test
Time frame: 12 weeks
Pulmonary function
Time frame: 12 weeks
6-minute walk test
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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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.
Rongchang Chen study director
Guangzhou Institute of Respiratory Disease
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 COPD and Hypercapnic Respiratory Failure, 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 5 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: status not confirmed, as of the sponsor's last update on 5 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lili Guan (+8613422288665, dr_nickguan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial pressure of arterial blood carbon dioxide (PaCO2) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.