Lung Diseases, ObstructiveNCT02439333
Prospective Randomized Study of Nasal High Flow in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A study testing Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand) and nasal catheter or Venturi mask in people with Lung Diseases, Obstructive, run by Li Xuyan at 1 site in China.
Trial summary
The main oxygen therapy to the patients with acute exacerbation of Chronic obstructive pulmonary disease, who are mild to moderate respiratory insufficiency (arterial blood gas analysis showed pH = 7.35, PO2 < 60mmHg,PaCO2>45mmHg) or have achieved the traditional noninvasive ventilation support standard but can not… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Lung Diseases, Obstructive
- What is being tested?
- Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand) and nasal catheter or Venturi mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to 15 Jul 2019
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AECOPD patients.
- The results of blood gas analysis showed pH ≥7.35, PO2< 60mmHg, PaCO2> 45mmHg.
Who cannot join
- The study case has been incorporated into the hospital again.
- Refused to the NHF therapy.
- The Glasgow score < 8.
- Severe organ dysfunction (including liver and kidney dysfunction, decompensated acidosis, upper gastrointestinal bleeding, DIC, etc.)
Trial locations and contacts
1 site in 1 country.
China1 site
Department of respiratory and critical care medicine,Beijing Chao-yang Hospital
Beijing, Beijing Municipality, 100020
About this study
The main oxygen therapy to the patients with acute exacerbation of Chronic obstructive pulmonary disease, who are mild to moderate respiratory insufficiency (arterial blood gas analysis showed pH = 7.35, PO2 < 60mmHg,PaCO2>45mmHg) or have achieved the traditional noninvasive ventilation support standard but can not tolerate or reject, was nasal catheter, venturi mask and other conventional oxygen therapy. All these inaccurate inhaled oxygen concentration methods with inadequate heating and humidifying lead to poor patient tolerance and adverse reactions such as airway secretions discharge disorders. The high flow nasal respiratory therapy (Nasal high flow, NHF) utilises higher gas flow rates than conventional low-flow oxygen systems. The devices used deliver heated and humidified oxygen at a flow of up to 60 litres per minute via nasal cannulas with low level continous positive airway pressure. This study is a prospective randomized study. AECOPD patients with no severe respiratory failure are treated with NHF and conventional oxygen therapy respectively. The target is that NHF can increase the comfort degree of patients,reduce the rate of endotracheal intubation, and shorten the time of hospitalization.
- Conditions
- Lung Diseases, Obstructive
- Being tested
- Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand), nasal catheter or Venturi mask
- Keywords
- Acute exacerbation of chronic obstructive pulmonary disease, Nasal high flow therapy, Oxygen therapy
- Medical subject headings
- Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand)Device
Nasal high flow therapy
nasal catheter or Venturi maskDevice
Conventional oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| Nasal high flow therapy | Active comparator | AECOPD patients with no severe respiratory insufficiency are given NHF therapy for at least 15 hours per day. Receives: Device: Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand) |
| Conventional oxygen therapy | Active comparator | AECOPD patients with no severe respiratory insufficiency are given conventional oxygen therapy such as nasal catheter or venturi mask for at least 15 hours per day. Receives: Device: nasal catheter or Venturi mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure criteria
Patients with mild respiratory acidosis (7.25 < pH < 7.35) with obvious dyspnea (accessory respiratory muscle involvement, breathing rate greater than 25 beats per minute)
Measured: 5 days
Secondary outcomes (2)
Length of hospital stay
Measured: 30 days
Costs of hospitalization expenses
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2019
- Study completion15 Jul 2019
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 Lung Diseases, ObstructiveStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Li Xuyan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Xuyan, Beijing Chao Yang Hospital
- Investigators
- Bing Sun, MD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439333
- Sponsor's protocol ID
- 2015-KE-63
- Status last verified
- May 2018
- First submitted
- 7 May 2015
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li XY, Tang X, Wang R, Yuan X, Zhao Y, Wang L, Li HC, Chu HW, Li J, Mao WP, Wang YJ, Tian ZH, Liu JH, Luo Q, Sun B, Tong ZH. High-Flow Nasal Cannula for Chronic Obstructive Pulmonary Disease with Acute Compensated Hypercapnic Respiratory Failure: A Randomized, Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Nov 24;15:3051-3061. doi: 10.2147/COPD.S283020. eCollection 2020.
PubMed 33262584
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of Nasal High Flow in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02439333
- Acronym / sponsor ID
- 2015-KE-63
- Conditions
- Lung Diseases, Obstructive
- Keywords
- Acute exacerbation of chronic obstructive pulmonary disease, Nasal high flow therapy, Oxygen therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Li XuyanUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 8 May 2015 (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.
The main oxygen therapy to the patients with acute exacerbation of Chronic obstructive pulmonary disease, who are mild to moderate respiratory insufficiency (arterial blood gas analysis showed pH = 7.35, PO2 < 60mmHg,PaCO2>45mmHg) or have achieved the traditional noninvasive ventilation support standard but can not tolerate or reject, was nasal catheter, venturi mask and other conventional oxygen therapy. All these inaccurate inhaled oxygen concentration methods with inadequate heating and humidifying lead to poor patient tolerance and adverse reactions such as airway secretions discharge disorders. The high flow nasal respiratory therapy (Nasal high flow, NHF) utilises higher gas flow rates than conventional low-flow oxygen systems. The devices used deliver heated and humidified oxygen at a flow of up to 60 litres per minute via nasal cannulas with low level continous positive airway pressure. This study is a prospective randomized study. AECOPD patients with no severe respiratory failure are treated with NHF and conventional oxygen therapy respectively. The target is that NHF can increase the comfort degree of patients,reduce the rate of endotracheal intubation, and shorten the time of hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal high flow therapy | Active comparator | Device: Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand)AECOPD patients with no severe respiratory insufficiency are given NHF therapy for at least 15 hours per day. |
| Conventional oxygen therapy | Active comparator | Device: nasal catheter or Venturi maskAECOPD patients with no severe respiratory insufficiency are given conventional oxygen therapy such as nasal catheter or venturi mask for at least 15 hours per day. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- AECOPD patients.
- The results of blood gas analysis showed pH ≥7.35, PO2< 60mmHg, PaCO2> 45mmHg.
Key exclusion criteria (4 listed)
- The study case has been incorporated into the hospital again.
- Refused to the NHF therapy.
- The Glasgow score < 8.
- Severe organ dysfunction (including liver and kidney dysfunction, decompensated acidosis, upper gastrointestinal bleeding, DIC, etc.)
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 |
|---|---|---|
| Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand)Nasal high flow therapy | Device | Nasal high flow therapy |
| nasal catheter or Venturi maskConventional oxygen therapy | Device | Conventional oxygen therapy |
Primary outcome
Treatment failure criteria
Time frame: 5 days
Patients with mild respiratory acidosis (7.25 < pH < 7.35) with obvious dyspnea (accessory respiratory muscle involvement, breathing rate greater than 25 beats per minute)
2 secondary outcomes
Length of hospital stay
Time frame: 30 days
Costs of hospitalization expenses
Time frame: 30 days
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 18 Jan 2020.
- Derived from this study: PubMed 33262584Li XY, Tang X, Wang R, Yuan X, Zhao Y, Wang L, Li HC, Chu HW, Li J, Mao WP, Wang YJ, Tian ZH, Liu JH, Luo Q, Sun B, Tong ZH. High-Flow Nasal Cannula for Chronic Obstructive Pulmonary Disease with Acute Compensated Hypercapnic Respiratory Failure: A Randomized, Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Nov 24;15:3051-3061. doi: 10.2147/COPD.S283020. eCollection 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.
Bing Sun, 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 Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand) and nasal catheter or Venturi mask in people with Lung Diseases, Obstructive, run by Li Xuyan 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 2 inclusion and 4 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 18 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?
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?
Treatment failure criteria (time frame: 5 days). 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 NCT02439333, 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 18 Jan 2020.