Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseNCT04044625
Effects of High-intensity Noninvasive Positive Pressure Ventilation in AECOPD
A study testing High-intensity NPPV and Low-intensity NPPV in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
This study aims to investigate the effects of high-intensity noninvasive positive pressure ventilation (NPPV), as compared with low-intensity NPPV, on hypercapnia, consciousness, inspiratory muscle effort, dyspnea, NPPV tolerance, inflammatory response, adverse events and other outcomes in patients with acute… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- What is being tested?
- High-intensity NPPV and Low-intensity NPPV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2019to 16 Jun 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD according to the criteria of the Global Initiative for Chronic Obstructive Lung Disease in 2019
- Presence of acute exacerbation
- Arterial pH <7.35 with arterial carbon dioxide tension (PaCO2) >45 mmHg on room air or supplemental oxygen
- PaCO2 >45 mmHg following low-intensity NPPV of ≥6 hours
Who cannot join
- Age <18 years
- Excessive amount of respiratory secretions or weak cough
- Upper airway obstruction
- Recent oral, facial, or cranial trauma or surgery; recent gastric or esophageal surgery
- Potential risk factors for restrictive ventilatory dysfunction (eg, consolidation or removal of at least one pulmonary lobe, massive pleural effusion, chest wall deformity, continuous strapping with thoracic or abdominal bandage, and severe abdominal distention)
- Active upper gastrointestinal bleeding
Show all 14Show fewer
- Cardiac or respiratory arrest
- Arterial oxygen tension/fraction of inspired oxygen <100 mmHg
- Pneumothorax
- Severe ventricular arrhythmia or myocardial ischemia
- Severe hemodynamic instability despite fluid repletion and use of vasoactive agents
- Severe metabolic acidosis
- Refusal to receive NPPV
- Endotracheal intubation already performed before ICU admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High-intensity Versus Low-intensity Noninvasive Positive Pressure Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
This study aims to investigate the effects of high-intensity noninvasive positive pressure ventilation (NPPV), as compared with low-intensity NPPV, on hypercapnia, consciousness, inspiratory muscle effort, dyspnea, NPPV tolerance, inflammatory response, adverse events and other outcomes in patients with acute exacerbation of chronic obstructive pulmonary disease.
- Being tested
- High-intensity NPPV, Low-intensity NPPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity NPPVDevice
In the high-intensity NPPV group, patients will undergo pressure-limited NPPV (eg, NPPV in spontaneous/timed mode) at a higher IPAP level. IPAP is initially set at 10 cmH2O and continuously adjusted by increments and decrements of 1-2 cmH2O (typically ranging between 20 and 30 cmH2O), according to patients' tolerance, to obtain a tidal volume (VT) of 10-15 mL/kg. IPAP should be increased as much as possible to decrease PaCO2 to a normal level. However, if PaCO2 decreases to less than 35 mmHg, IPAP should be decreased to achieve normocapnia.
Low-intensity NPPVDevice
In the low-intensity NPPV group, patients will undergo pressure-limited NPPV (eg, NPPV in spontaneous/timed mode) with a conventional IPAP level. IPAP is initially set to 10 cmH2O and is continuously adjusted by increments and decrements of 1-2 cmH2O (up to 20 cmH2O), according to patients' tolerance, to obtain a VT of 6-10 mL/kg.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity NPPV | Experimental | The patients will receive high-intensity noninvasive positive pressure ventilation. Receives: Device: High-intensity NPPV |
| Low-intensity NPPV | Active comparator | The patients will receive low-intensity noninvasive positive pressure ventilation. Receives: Device: Low-intensity NPPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaCO2 measured at 24 hours after enrollment
PaCO2 measured at 24 hours after enrollment.
Measured: 24 hours
Secondary outcomes (13)
PaCO2 measured at 2 hours after enrollment
PaCO2 measured at 2 hours after enrollment
Measured: 2 hours
PaCO2 measured at 6 hours after enrollment
PaCO2 measured at 6 hours after enrollment
Measured: 6 hours
PaCO2 measured at 48 hours after enrollment
PaCO2 measured at 48 hours after enrollment
Measured: 48 hours
PaCO2 measured at 72 hours after enrollment
PaCO2 measured at 72 hours after enrollment
Measured: 72 hours
Glasgow coma scale score
The glasgow coma scale score, ranging from 3 (coma) to 15 (normal consciousness), will be used to assess the consciousness level.
Measured: 72 hours
ΔPes
Inspiratory esophageal pressure swing
Measured: 72 hours
Dyspnea score
The dyspnea score will be assessed using a verbal analogue scale with levels from 0 (no dyspnea) to 10 (maximum dyspnea).
Measured: 72 hours
NPPV tolerance score
NPPV tolerance will be recorded on a 4-point scale and then dichotomized into acceptable (score of 2 or 3) or poor (score of 0 or 1) tolerance.
Measured: 72 hours
Plasma level of TNF-α
Plasma level of TNF-α
Measured: 72 hours
Plasma level of I-1β
Plasma level of IL-1β
Measured: 72 hours
Plasma level of IL-6
Plasma level of IL-6
Measured: 72 hours
Plasma level of IL-8
Plasma level of IL-8
Measured: 72 hours
Plasma level of IL-10
Plasma level of IL-10
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start30 Sep 2019
- Primary completion19 Mar 2021
- Study completion16 Jun 2021
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 Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zujin Luo, Beijing Chao Yang Hospital
- Investigators
- Zujin Luo, MD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044625
- Sponsor's protocol ID
- BeijingCYH-ICU-007
- Status last verified
- May 2022
- First submitted
- 21 May 2019
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luo Z, Cao Z, Li Y, Jin J, Sun W, Zhu J, Zhao N, Liu J, Wei B, Hu Y, Zhang Y, Ma Y, Wang C. Physiological effects of high-intensity versus low-intensity noninvasive positive pressure ventilation in patients with acute exacerbation of chronic obstructive pulmonary disease: a randomised controlled trial. Ann Intensive Care. 2022 May 19;12(1):41. doi: 10.1186/s13613-022-01018-4.
PubMed 35587843
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-intensity Versus Low-intensity Noninvasive Positive Pressure Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04044625
- Acronym / sponsor ID
- BeijingCYH-ICU-007
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 16 Jun 2021 (actual)
- First posted
- 5 Aug 2019 (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.
This study aims to investigate the effects of high-intensity noninvasive positive pressure ventilation (NPPV), as compared with low-intensity NPPV, on hypercapnia, consciousness, inspiratory muscle effort, dyspnea, NPPV tolerance, inflammatory response, adverse events and other outcomes in patients with acute exacerbation of chronic obstructive pulmonary disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity NPPV | Experimental | Device: High-intensity NPPVThe patients will receive high-intensity noninvasive positive pressure ventilation. |
| Low-intensity NPPV | Active comparator | Device: Low-intensity NPPVThe patients will receive low-intensity noninvasive positive pressure ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of COPD according to the criteria of the Global Initiative for Chronic Obstructive Lung Disease in 2019
- Presence of acute exacerbation
- Arterial pH <7.35 with arterial carbon dioxide tension (PaCO2) >45 mmHg on room air or supplemental oxygen
- PaCO2 >45 mmHg following low-intensity NPPV of ≥6 hours
Key exclusion criteria (14 listed)
- Age <18 years
- Excessive amount of respiratory secretions or weak cough
- Upper airway obstruction
- Recent oral, facial, or cranial trauma or surgery; recent gastric or esophageal surgery
- Potential risk factors for restrictive ventilatory dysfunction (eg, consolidation or removal of at least one pulmonary lobe, massive pleural effusion, chest wall deformity, continuous strapping with thoracic or abdominal bandage, and severe abdominal distention)
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 |
|---|---|---|
| High-intensity NPPVIn the high-intensity NPPV group, patients will undergo pressure-limited NPPV (eg, NPPV in spontaneous/timed mode) at a higher IPAP level. IPAP is initially set at 10 cmH2O and continuously adjusted by increments and decrements of 1-2 cmH2O (typically ranging between 20 and 30 cmH2O), according to patients' tolerance, to obtain a tidal volume (VT) of 10-15 mL/kg. IPAP should be increased as much as possible to decrease PaCO2 to a normal level. However, if PaCO2 decreases to less than 35 mmHg, IPAP should be decreased to achieve normocapnia. | Device | High-intensity NPPV |
| Low-intensity NPPVIn the low-intensity NPPV group, patients will undergo pressure-limited NPPV (eg, NPPV in spontaneous/timed mode) with a conventional IPAP level. IPAP is initially set to 10 cmH2O and is continuously adjusted by increments and decrements of 1-2 cmH2O (up to 20 cmH2O), according to patients' tolerance, to obtain a VT of 6-10 mL/kg. | Device | Low-intensity NPPV |
Primary outcome
PaCO2 measured at 24 hours after enrollment
Time frame: 24 hours
PaCO2 measured at 24 hours after enrollment.
13 secondary outcomes
PaCO2 measured at 2 hours after enrollment
Time frame: 2 hours
PaCO2 measured at 6 hours after enrollment
Time frame: 6 hours
PaCO2 measured at 48 hours after enrollment
Time frame: 48 hours
PaCO2 measured at 72 hours after enrollment
Time frame: 72 hours
Glasgow coma scale score
Time frame: 72 hours
ΔPes
Time frame: 72 hours
Dyspnea score
Time frame: 72 hours
NPPV tolerance score
Time frame: 72 hours
Plasma level of TNF-α
Time frame: 72 hours
Plasma level of I-1β
Time frame: 72 hours
Plasma level of IL-6
Time frame: 72 hours
Plasma level of IL-8
Time frame: 72 hours
Plasma level of IL-10
Time frame: 72 hours
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 10 May 2022.
- Derived from this study: PubMed 35587843Luo Z, Cao Z, Li Y, Jin J, Sun W, Zhu J, Zhao N, Liu J, Wei B, Hu Y, Zhang Y, Ma Y, Wang C. Physiological effects of high-intensity versus low-intensity noninvasive positive pressure ventilation in patients with acute exacerbation of chronic obstructive pulmonary disease: a randomised controlled trial. Ann Intensive Care. 2022 May 19;12(1):41. doi: 10.1186/s13613-022-01018-4.
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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.
Zujin Luo, MD principal investigator
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity NPPV and Low-intensity NPPV in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Beijing Chao Yang Hospital 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 4 inclusion and 14 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 10 May 2022. 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?
PaCO2 measured at 24 hours after enrollment (time frame: 24 hours). 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 NCT04044625, 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 10 May 2022.