Respiratory FailureNCT02687074
Effects of HFNC on Moderate and Severe Respiratory Failure Patients
A study testing HFNC and NIV in people with Respiratory Failure, run by Southeast University, China.
Trial summary
Respiratory failure is the danger for the patients admitted in ICU, mechanical ventilation could save a lot of patients' life, however, it prolongs patients' ICU stay and hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- HFNC and NIV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years
- patients met all four of the following criteria:
- a respiratory rate of more than 25 breaths per minute,
- a ratio of the partial pressure of arterial oxygen (Pao2) to the Fio2 of 300 mm Hg or less while the patient was breathing oxygen at a flow rate of 10 liters per minute or more for at least 15 minutes,
- a partial pressure of arterial carbon dioxide (Paco2) not higher than 45 mmHg, and
- an absence of clinical history of underlying chronic respiratory failure
Who cannot join
- Paco2 of more than 45 mm Hg
- exacerbation of asthma or chronic respiratory failure
- cardiogenic pulmonary edema
- severe neutropenia
- hemodynamic instability, use of vasopressors,
- Glasgow Coma Scale score of 12 points or less (on a scale from 3 to 15, with lower scores indicating reduced levels of consciousness)
- contraindications to noninvasive ventilation
- urgent need for endotracheal intubation, a do-not-intubate order, and a decision not to participate.
About this study
Official title: Effects of High Flow Nasal Canula on Moderate and Severe Respiratory Failure Patients
Respiratory failure is the danger for the patients admitted in ICU, mechanical ventilation could save a lot of patients' life, however, it prolongs patients' ICU stay and hospital stay. High flow nasal cannula (HFNC) has advantages of PEEP effects, reducing dead space, increasing EELV and improving comfort, and it has been used to treat respiratory failure patients. In recent study, HFNC could improve mortality of respiratory failure patients with P/F<200mmHg in the subgroup. The investigators want to start a randomized controlled study to evaluate the effects of HFNC on the patients with respiratory failure.
Read the detailed description
just as the brief summary
- Conditions
- Respiratory Failure
- Being tested
- HFNC, NIV
- Keywords
- HFNC, Respiratory Failure, Intubation, Mortality
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNCDevice
patients treated with high flow nasal cannula
NIVDevice
patients treated with noninvasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| Intubation rate on 28 days | Experimental | patients with respiratory failure treat with HFNC or NIV and intubation rate on 28 days Receives: Device: HFNC; Device: NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation rate on 28 days
Measured: up to 28 days
Secondary outcomes (2)
Duration of ICU stay
Measured: date of death from any cause, whichever came first, assessed up to 90 days
Duration of hospital stay
Measured: date of death from any cause, whichever came first, assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Suzhou Medical College, Second Affiliated Hospital of Suzhou University, Zhangjiagang First People's Hospital, The Second Hospital of Nanjing Medical University, Wuxi No. 4 People's Hospital
- Responsible party
- Principal investigator, Chun Pan, Southeast University, China
- Investigators
- Chun Pan, Dr, Study chair, Zhongda hospital, Southeast University, Jiangsu, ChinaFuxi Sun, Dr, Principal investigator, Nanjing Medical University affiliated Second HospitalWei Liu, Dr, Principal investigator, Wuxi HospitalJianfeng Xie, Dr, Principal investigator, Suzhou Shili HospitalSongqiao Liu, Dr, Principal investigator, Suzhou Sencond HospitalLing Liu, Dr, Principal investigator, Zhangjiagang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687074
- Sponsor's protocol ID
- |HFNC study
- Status last verified
- Feb 2016
- First submitted
- 27 Jan 2016
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Flow Nasal Canula on Moderate and Severe Respiratory Failure Patients
- ClinicalTrials.gov ID
- NCT02687074
- Acronym / sponsor ID
- |HFNC study
- Conditions
- Respiratory Failure
- Keywords
- HFNC, Respiratory Failure, Intubation, Mortality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Suzhou Medical College, Second Affiliated Hospital of Suzhou University, Zhangjiagang First People's Hospital, The Second Hospital of Nanjing Medical University, Wuxi No. 4 People's Hospital
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Feb 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.
Respiratory failure is the danger for the patients admitted in ICU, mechanical ventilation could save a lot of patients' life, however, it prolongs patients' ICU stay and hospital stay. High flow nasal cannula (HFNC) has advantages of PEEP effects, reducing dead space, increasing EELV and improving comfort, and it has been used to treat respiratory failure patients. In recent study, HFNC could improve mortality of respiratory failure patients with P/F<200mmHg in the subgroup. The investigators want to start a randomized controlled study to evaluate the effects of HFNC on the patients with respiratory failure.
Detailed description
just as the brief summary
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubation rate on 28 days | Experimental | Device: HFNC, Device: NIVpatients with respiratory failure treat with HFNC or NIV and intubation rate on 28 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age>18 years
- patients met all four of the following criteria:
Key exclusion criteria (8 listed)
- Paco2 of more than 45 mm Hg
- exacerbation of asthma or chronic respiratory failure
- cardiogenic pulmonary edema
- severe neutropenia
- hemodynamic instability, use of vasopressors,
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 |
|---|---|---|
| HFNCpatients treated with high flow nasal cannula | Device | Intubation rate on 28 days |
| NIVpatients treated with noninvasive ventilation | Device | Intubation rate on 28 days |
Primary outcome
intubation rate on 28 days
Time frame: up to 28 days
2 secondary outcomes
Duration of ICU stay
Time frame: date of death from any cause, whichever came first, assessed up to 90 days
Duration of hospital stay
Time frame: date of death from any cause, whichever came first, assessed up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Individual participant dataSharing planned: Undecided
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Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
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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.
Chun Pan, Dr study chair
Zhongda hospital, Southeast University, Jiangsu, China
Fuxi Sun, Dr principal investigator
Nanjing Medical University affiliated Second Hospital
Wei Liu, Dr principal investigator
Wuxi Hospital
Questions about this trial
What is this clinical trial studying?
A study testing HFNC and NIV in people with Respiratory Failure, run by Southeast University, 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 6 inclusion and 8 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 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
intubation rate on 28 days (time frame: up to 28 days). 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 22 Feb 2016.