High Flow Nasal CannulaNCT04560842
The Efficacy of High-flow Nasal Cannula Oxygen Therapy in Sepsis Patients
A study testing A high flow oxygen device. and Conventional oxygen therapy in people with High Flow Nasal Cannula and Sepsis Syndrome, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
Sepsis is a heterogeneous syndrome that is caused by the host imbalance immune response. At 1991, the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference developed a definition of sepsis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- High Flow Nasal Cannula, Sepsis Syndrome
- What is being tested?
- A high flow oxygen device. and Conventional oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Sep 2020to 24 Sep 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 20 years.
- Pneumonia definitions.
- Diagnosis on admission was sepsis due to pneumonia or septic shock (Sepsis-3).
Who cannot join
- Patients with human immunodeficiency virus (HIV)
- Pregnant women.
- There are contraindications to the inability to use HFNC.
- The patient who refuses to insert an endotracheal tube.
- The patient who has tracheostomy.
- The patient who use norepinaphrine(Levophed)≧0.75 mcg/kg/min。
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- The patient who meet the definition of endotracheal tube insertion.
- The patient who meet the definition of noninvasive ventilation, NIV.
- The patient who has risk factors prone to sepsis(Kidney infection and UTI, abdominal, skin and soft tissue, fever of unknown origin, surgical wound, IV/central/dialysis catheter, meningitis)。
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Mackay Memorial Hospital
Taipei
Shuo Ping Tseng, 886-989452824, you_8012@hotmail.com
About this study
Sepsis is a heterogeneous syndrome that is caused by the host imbalance immune response. At 1991, the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference developed a definition of sepsis. After more than 20 years, it was gradually developed in 2016 to the third edition of the guidelines for sepsis(Sepsis-3). Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. According to the National Health Insurance claims database of Taiwan, The incidence rate was 772.1/100,000 persons in 2012. From 2002 to 2012, the incidence of sepsis increased by 18.7%. The mortality of severe sepsis was 17.9%. However, has increased to 33% when developed to septic shock. Even in foreign studies, the intensive care unit mortality rate can reach 40%. Although sepsis was defined in 1991, after these years, the treatment of sepsis is still a goal that must be worked hard.
According to Sepsis-3, must first use the qSOFA (quick Sepsis Related Organ Failure Assessment) to assess whether the patient's blood pressure, respiratory rate, and state of consciousness meet more than two criteria, which is sepsis. If the SOFA score (Sequential Organ Failure Assessment) is further evaluated, with at least two of the following symptoms, including poor oxygenation in the lungs, hypotension or use of a vasopressor, thrombocytopenia, conscious change (Glasgow Coma Scale), bilirubin increase and creatinine rise or oligouria. If the patient must use a vasopressor to maintain a mean arterial pressure (MAP) of 65 mmHg and serum lactate more than 18 mg/dL, it is Septic shock. In clinical assessment, qSOFA (rapid sepsis-associated organ failure assessment) can also be used to assess blood pressure, respiratory rate, and state of consciousness to confirmed sepsis. According to the above assessment conditions, patients with sepsis are highly prone to respiratory failure during the disease process. In recent trials, about 40% to 85% of patients with sepsis must be need endotracheal intubation, showing the high intubation rate. Patients after intubation may cause lung injury due to improper ventilator settings (Ventilator-induced lung injury, VILI). And 10% to 25% will be combined with pneumonia caused by the ventilator (ventilator-associated pneumonia, VAP). Mortality can reach 20% to 33%. So if we can reduce septic patient's intubation rate then we can reduce the complication caused by the ventilator.
Read more
A high flow nasal cannula (HFNC) is a relatively new device for respiratory support. Patients received high-flow conditioned oxygen therapy through a nasal prong. A number of physiological effects have been described with HFNC: pharyngeal dead space washout, a positive expiratory pressure to reduce work of breathing, improve breathing synchronization. These benefits can reduce the intubation rate.
The benefit of the HFNC in septic patients is not very clear. By this prospective study to investigate the septic patients who have been admitted to the intensive care unit. The study method is to ask the patient whether they agree to participate in the trial after the patient is transferred to the intensive care unit. The patient will randomly assign the subjects to the general oxygen therapy and the HFNC group after signing the subject consent form. This study aimed to determine whether high-flow oxygen therapy immediately would reduce the need for intubation compared with standard oxygen therapy in sepsis patients.
- Conditions
- High Flow Nasal Cannula, Sepsis Syndrome
- Being tested
- A high flow oxygen device., Conventional oxygen therapy
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A high flow oxygen device.Device
The HFNC group use high flow oxygen device for 48 hours
Conventional oxygen therapyDevice
Conventional oxygen device
| Study group | Role | What they receive |
|---|---|---|
| Conventional oxygen devise | Experimental | Chose devise to keep patient's SpO2 > 92% Receives: Device: Conventional oxygen therapy |
| High flow nasal cannula | Active comparator | High flow oxygen device Receives: Device: A high flow oxygen device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation rate
How many patients intubate in a year.
Measured: A year
Secondary outcomes (4)
Hospital days
The number of days in hospital
Measured: A year
ICU days
The number of days in ICU
Measured: A year
ICU mortality
ICU mortality
Measured: A year
Hospital mortality
Hospital mortality
Measured: A year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start25 Sep 2020 (estimated)
- Primary completion24 Sep 2021 (estimated)
- Study completion24 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Flow Nasal CannulaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560842
- Sponsor's protocol ID
- 18MMHIS189
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of High-flow Nasal Cannula Oxygen Therapy in Sepsis Patients
- ClinicalTrials.gov ID
- NCT04560842
- Acronym / sponsor ID
- 18MMHIS189
- Conditions
- High Flow Nasal Cannula, Sepsis Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 25 Sep 2020 (estimated)
- Primary completion
- 24 Sep 2021 (estimated)
- Study completion
- 24 Sep 2021 (estimated)
- First posted
- 23 Sep 2020 (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.
Sepsis is a heterogeneous syndrome that is caused by the host imbalance immune response. At 1991, the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference developed a definition of sepsis. After more than 20 years, it was gradually developed in 2016 to the third edition of the guidelines for sepsis(Sepsis-3). Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. According to the National Health Insurance claims database of Taiwan, The incidence rate was 772.1/100,000 persons in 2012. From 2002 to 2012, the incidence of sepsis increased by 18.7%. The mortality of severe sepsis was 17.9%. However, has increased to 33% when developed to septic shock. Even in foreign studies, the intensive care unit mortality rate can reach 40%. Although sepsis was defined in 1991, after these years, the treatment of sepsis is still a goal that must be worked hard.
According to Sepsis-3, must first use the qSOFA (quick Sepsis Related Organ Failure Assessment) to assess whether the patient's blood pressure, respiratory rate, and state of consciousness meet more than two criteria, which is sepsis. If the SOFA score (Sequential Organ Failure Assessment) is further evaluated, with at least two of the following symptoms, including poor oxygenation in the lungs, hypotension or use of a vasopressor, thrombocytopenia, conscious change (Glasgow Coma Scale), bilirubin increase and creatinine rise or oligouria. If the patient must use a vasopressor to maintain a mean arterial pressure (MAP) of 65 mmHg and serum lactate more than 18 mg/dL, it is Septic shock. In clinical assessment, qSOFA (rapid sepsis-associated organ failure assessment) can also be used to assess blood pressure, respiratory rate, and state of consciousness to confirmed sepsis. According to the above assessment conditions, patients with sepsis are highly prone to respiratory failure during the disease process. In recent trials, about 40% to 85% of patients with sepsis must be need endotracheal intubation, showing the high intubation rate. Patients after intubation may cause lung injury due to improper ventilator settings (Ventilator-induced lung injury, VILI). And 10% to 25% will be combined with pneumonia caused by the ventilator (ventilator-associated pneumonia, VAP). Mortality can reach 20% to 33%. So if we can reduce septic patient's intubation rate then we can reduce the complication caused by the ventilator.
A high flow nasal cannula (HFNC) is a relatively new device for respiratory support. Patients received high-flow conditioned oxygen therapy through a nasal prong. A number of physiological effects have been described with HFNC: pharyngeal dead space washout, a positive expiratory pressure to reduce work of breathing, improve breathing synchronization. These benefits can reduce the intubation rate.
The benefit of the HFNC in septic patients is not very clear. By this prospective study to investigate the septic patients who have been admitted to the intensive care unit. The study method is to ask the patient whether they agree to participate in the trial after the patient is transferred to the intensive care unit. The patient will randomly assign the subjects to the general oxygen therapy and the HFNC group after signing the subject consent form. This study aimed to determine whether high-flow oxygen therapy immediately would reduce the need for intubation compared with standard oxygen therapy in sepsis patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional oxygen devise | Experimental | Device: Conventional oxygen therapyChose devise to keep patient's SpO2 > 92% |
| High flow nasal cannula | Active comparator | Device: A high flow oxygen device.High flow oxygen device |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age older than 20 years.
- Pneumonia definitions.
- Diagnosis on admission was sepsis due to pneumonia or septic shock (Sepsis-3).
Key exclusion criteria (9 listed)
- Patients with human immunodeficiency virus (HIV)
- Pregnant women.
- There are contraindications to the inability to use HFNC.
- The patient who refuses to insert an endotracheal tube.
- The patient who has tracheostomy.
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 |
|---|---|---|
| A high flow oxygen device.The HFNC group use high flow oxygen device for 48 hours | Device | High flow nasal cannula |
| Conventional oxygen therapyConventional oxygen device | Device | Conventional oxygen devise |
Primary outcome
Intubation rate
Time frame: A year
How many patients intubate in a year.
4 secondary outcomes
Hospital days
Time frame: A year
ICU days
Time frame: A year
ICU mortality
Time frame: A year
Hospital mortality
Time frame: A year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A high flow oxygen device. and Conventional oxygen therapy in people with High Flow Nasal Cannula and Sepsis Syndrome, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 9 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 Sep 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 Taiwan. 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 Shuo Ping Tseng (886-989452824, you_8012@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation rate (time frame: A year). 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 Sep 2020.