Patients With Respiratory InsufficiencyNCT02972021
High Flow Nasal Cannulae Oxygen Therapy in Respiratory Insufficiency Patients
A study testing High-flow nasal cannula in people with Patients With Respiratory Insufficiency, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Chronic respiratory insufficiency in patients with advanced disease to the late treatment depends mainly on mechanical ventilation and other high intensity respiratory support therapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Patients With Respiratory Insufficiency
- What is being tested?
- High-flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2018
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic respiratory insufficiency who require long-term oxygen therapy.
- Age 18-85 years old. Agree to participate in this study.
Who cannot join
- Patients with advanced respiratory support (invasive mechanical ventilation, noninvasive mechanical ventilation) indications Cardiovascular disease caused by respiratory insufficiency Immune dysfunction caused by respiratory insufficiency Tumor-induced respiratory insufficiency People with disturbance of consciousness
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth Hospital
Shanghai, Shanghai Municipality, 200072
HU PENG, MD, chenyuanzhuo021@hotmail.com
About this study
Chronic respiratory insufficiency in patients with advanced disease to the late treatment depends mainly on mechanical ventilation and other high intensity respiratory support therapy. Strengthen the stability of chronic respiratory insufficiency intervention can reduce the frequency and extent of acute disease, saving medical resources.High-flow nasal cannula (HFNC), as a new non-invasive oxygen therapy system, has gradually become a weapon of respiratory support therapy. There is little research on the role of HFNC in oxygen therapy for chronic respiratory insufficiency.
Our previous studies have found the potential value of HFNC in chronic respiratory insufficiency. The aim of this project is to promote the use of HFNC in the t reatment of chronic respiratory insufficiency in HFRS in Shanghai first, second and third grade hospitals in an effort to confirm that HFNC can improve the prognosis of patients with chronic respiratory insufficiency compared with nasal oxygen therapy.
Read the detailed description
- To confirm HFNC used in patients with chronic respiratory insufficiency oxygen therapy than the general nasal catheter oxygen and the difference between what better.
- We set up a point of research in the tertiary hospitals, secondary hospitals and primary hospitals to explore the different levels of HFNC in the application of the efficacy of the hospital there are differences and what is better. To further clarify the promotion of HFNC to secondary hospitals and primary hospitals have no meaning.
- Patients with chronic respiratory insufficiency who required long-term oxygen therapy were randomized to a randomized, controlled, multicentre clinical trial of HFNC with nasal oxygen therapy. Analysis and comparison of HFNC and general nasal catheter oxygen in the treatment of chronic respiratory insufficiency there is no difference, HFNC in different grades of hospital use is consistent.
- Research methods:
4.1 Subjects: Chronic respiratory insufficiency required long-term oxygen therapy to Shanghai Tenth People's Hospital and multi-center hospital patients.
4.2 Study sample size: 100 samples were collected from each of the three test centers. Of which 150 cases of nasal oxygen therapy, HFNC 150 cases.
- Conditions
- Patients With Respiratory Insufficiency
- Being tested
- High-flow nasal cannula
- Keywords
- respiratory insufficiency, High-flow nasal cannula
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal cannulaDevice
| Study group | Role | What they receive |
|---|---|---|
| control | Other | Pure oxygen by nasal cannula group Receives: Device: High-flow nasal cannula |
| HFNC | Experimental | oxygen by High-flow nasal cannula Receives: Device: High-flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve dyspnea score
Measured: up to 12 months after oxygen therapy
Length of hospital stay
Measured: up to 12 months after oxygen therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Respiratory InsufficiencyStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Yuanzhuo, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972021
- Sponsor's protocol ID
- shsk20160722
- Status last verified
- Nov 2016
- First submitted
- 21 Nov 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannulae Oxygen Therapy in Respiratory Insufficiency Patients
- ClinicalTrials.gov ID
- NCT02972021
- Acronym / sponsor ID
- shsk20160722
- Conditions
- Patients With Respiratory Insufficiency
- Keywords
- respiratory insufficiency, High-flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- First posted
- 23 Nov 2016 (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.
Chronic respiratory insufficiency in patients with advanced disease to the late treatment depends mainly on mechanical ventilation and other high intensity respiratory support therapy. Strengthen the stability of chronic respiratory insufficiency intervention can reduce the frequency and extent of acute disease, saving medical resources.High-flow nasal cannula (HFNC), as a new non-invasive oxygen therapy system, has gradually become a weapon of respiratory support therapy. There is little research on the role of HFNC in oxygen therapy for chronic respiratory insufficiency.
Our previous studies have found the potential value of HFNC in chronic respiratory insufficiency. The aim of this project is to promote the use of HFNC in the t reatment of chronic respiratory insufficiency in HFRS in Shanghai first, second and third grade hospitals in an effort to confirm that HFNC can improve the prognosis of patients with chronic respiratory insufficiency compared with nasal oxygen therapy.
Detailed description
- To confirm HFNC used in patients with chronic respiratory insufficiency oxygen therapy than the general nasal catheter oxygen and the difference between what better.
- We set up a point of research in the tertiary hospitals, secondary hospitals and primary hospitals to explore the different levels of HFNC in the application of the efficacy of the hospital there are differences and what is better. To further clarify the promotion of HFNC to secondary hospitals and primary hospitals have no meaning.
- Patients with chronic respiratory insufficiency who required long-term oxygen therapy were randomized to a randomized, controlled, multicentre clinical trial of HFNC with nasal oxygen therapy. Analysis and comparison of HFNC and general nasal catheter oxygen in the treatment of chronic respiratory insufficiency there is no difference, HFNC in different grades of hospital use is consistent.
- Research methods:
4.1 Subjects: Chronic respiratory insufficiency required long-term oxygen therapy to Shanghai Tenth People's Hospital and multi-center hospital patients.
4.2 Study sample size: 100 samples were collected from each of the three test centers. Of which 150 cases of nasal oxygen therapy, HFNC 150 cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Other | Device: High-flow nasal cannulaPure oxygen by nasal cannula group |
| HFNC | Experimental | Device: High-flow nasal cannulaoxygen by High-flow nasal cannula |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with chronic respiratory insufficiency who require long-term oxygen therapy.
- Age 18-85 years old. Agree to participate in this study.
Key exclusion criteria (1 listed)
- Patients with advanced respiratory support (invasive mechanical ventilation, noninvasive mechanical ventilation) indications Cardiovascular disease caused by respiratory insufficiency Immune dysfunction caused by respiratory insufficiency Tumor-induced respiratory insufficiency People with disturbance of consciousness
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-flow nasal cannula | Device | HFNC, control |
Primary outcome
Improve dyspnea score
Time frame: up to 12 months after oxygen therapy
Length of hospital stay
Time frame: up to 12 months after oxygen therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
Related trials for Patients With Respiratory Insufficiency
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
Nasal Airway Obstruction
Not yet recruitingObservational study
Lactate/Albumin Ratio and Mortality in Respiratory Failure
Acute Respiratory Failure, Critical Illness
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
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-flow nasal cannula in people with Patients With Respiratory Insufficiency, run by Shanghai 10th People's 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 2 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 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HU PENG, MD (+821666304586, denkepeng@189.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve dyspnea score (time frame: up to 12 months after oxygen therapy). The study lists 2 primary outcomes in all. 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 Nov 2016.