COPDNCT04156139
HFNC vs NPPV After Early Extubation for Patients With COPD
A study testing HFNC and NPPV in people with COPD and Hypercapnic Respiratory Failure, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
High-flow nasal cannula oxygen therapy(HFNC) has proved no significant difference compared with noninvasive positive pressure ventilation (NPPV) in preventing postextubation respiratory failure and reintubation in patients with acute hypoxemic respiratory failure.However, the efficacy of early postextubation… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD, Hypercapnic Respiratory Failure
- What is being tested?
- HFNC and NPPV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2019to 1 Nov 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. COPD patients with bronchopulmonary infection 2. Patients with hypercapnia respiratory failure treated with invasive mechanical 3.14 days ≥ invasive mechanical ventilation ≥ 48 hours; 4.Reached the pulmonary infection control (PIC) window; 5.Have self-care ability with oxygen supply during stable phrase
Who cannot join
- Severe organ dysfunction;Myopathy or myasthenia gravis;Upper airway obstruction;A large amount of secretions and inability to drain;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Cao jiang, MD, +86 010-66937166
About this study
Official title: High-flow Nasal Cannula Versus Noninvasive Positive Pressure Ventilation Therapy After Early Extubation for Patients With Chronic Obstructive Pulmonary Disease
High-flow nasal cannula oxygen therapy(HFNC) has proved no significant difference compared with noninvasive positive pressure ventilation (NPPV) in preventing postextubation respiratory failure and reintubation in patients with acute hypoxemic respiratory failure.However, the efficacy of early postextubation sequential HFNC in COPD patients with hypercapnic respiratory failure is inconclusive.
Read the detailed description
The investigators conducted this prospective randomized controlled trial to explore the efficacy, safety of HFNC versus NPPV after early extubation in COPD patients with hypercapnic respiratory failure.The investigators hypothesized that the efficacy of HFNC after early extubation is non-inferior to that of NPPV.
- Conditions
- COPD, Hypercapnic Respiratory Failure
- Being tested
- HFNC, NPPV
- Keywords
- NPPV, HFNC, Weaning, COPD, PIC
- 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.
HFNCDevice
The gas flow rate was set at 45~55 L/min. The inhaled oxygen concentration will be dynamically adjusted to maintain SpO2 ≥ 92%. The temperature will be set at 37 °C.
NPPVDevice
The PEEP is initially set as 5 cm H2O, the inspiratory pressure is 10 cm H2O, and the target tidal volume is 6-8 ml/kg.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | NPPV treatment for patients will be performed for patients immediately after extubation in control group. Receives: Device: HFNC; Device: NPPV |
| intervention group | Experimental | HFNC treatment will be performed for patients immediately after extubation in the intervention group. Receives: Device: HFNC; Device: NPPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
reintubation
The primary outcome is reintubation within the 7 days after extubation.
Measured: within the 7 days after extubation.
Secondary outcomes (1)
Weaning failure
Secondary Outcome is a composite criterion including reintubation events or all-cause deaths within the7 days after extubation
Measured: within the7 days after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start18 Dec 2019
- Primary completion1 May 2022 (estimated)
- Study completion1 Nov 2022 (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 Chinese PLA General 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
- None (open label)
- Enrolment
- 502 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Health Science Center
- Responsible party
- Principal investigator, Lixin Xie, Chinese PLA General Hospital
- Investigators
- XIE Lixin, MD, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156139
- Sponsor's protocol ID
- 2018ZX09201013
- Status last verified
- Jan 2020
- First submitted
- 1 Nov 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Cannula Versus Noninvasive Positive Pressure Ventilation Therapy After Early Extubation for Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04156139
- Acronym / sponsor ID
- 2018ZX09201013
- Conditions
- COPD, Hypercapnic Respiratory Failure
- Keywords
- NPPV, HFNC, Weaning, COPD, PIC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 502 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Peking University Health Science Center
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 7 Nov 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.
High-flow nasal cannula oxygen therapy(HFNC) has proved no significant difference compared with noninvasive positive pressure ventilation (NPPV) in preventing postextubation respiratory failure and reintubation in patients with acute hypoxemic respiratory failure.However, the efficacy of early postextubation sequential HFNC in COPD patients with hypercapnic respiratory failure is inconclusive.
Detailed description
The investigators conducted this prospective randomized controlled trial to explore the efficacy, safety of HFNC versus NPPV after early extubation in COPD patients with hypercapnic respiratory failure.The investigators hypothesized that the efficacy of HFNC after early extubation is non-inferior to that of NPPV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: HFNC, Device: NPPVNPPV treatment for patients will be performed for patients immediately after extubation in control group. |
| intervention group | Experimental | Device: HFNC, Device: NPPVHFNC treatment will be performed for patients immediately after extubation in the intervention group. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. COPD patients with bronchopulmonary infection 2. Patients with hypercapnia respiratory failure treated with invasive mechanical 3.14 days ≥ invasive mechanical ventilation ≥ 48 hours; 4.Reached the pulmonary infection control (PIC) window; 5.Have self-care ability with oxygen supply during stable phrase
Key exclusion criteria (1 listed)
- Severe organ dysfunction;Myopathy or myasthenia gravis;Upper airway obstruction;A large amount of secretions and inability to drain;
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 |
|---|---|---|
| HFNCThe gas flow rate was set at 45~55 L/min. The inhaled oxygen concentration will be dynamically adjusted to maintain SpO2 ≥ 92%. The temperature will be set at 37 °C. | Device | Control group, intervention group |
| NPPVThe PEEP is initially set as 5 cm H2O, the inspiratory pressure is 10 cm H2O, and the target tidal volume is 6-8 ml/kg. | Device | Control group, intervention group |
Primary outcome
reintubation
Time frame: within the 7 days after extubation.
The primary outcome is reintubation within the 7 days after extubation.
1 secondary outcome
Weaning failure
Time frame: within the7 days after extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No
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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.
XIE Lixin, MD study chair
Chinese PLA General 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 HFNC and NPPV in people with COPD and Hypercapnic Respiratory Failure, run by Chinese PLA General 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 1 inclusion and 1 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 23 Jan 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 Han Xiaobo, MD (+86 18600310765, hansir510@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reintubation (time frame: within the 7 days after extubation.). 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 23 Jan 2020.