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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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。
Show all 9Show fewer
  • 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.

Shuo Ping Tseng contact

886-989452824

you_8012@hotmail.com

Taiwan1 site
  • Mackay Memorial Hospital

    Taipei

    Shuo Ping Tseng, 886-989452824, you_8012@hotmail.com

Other trials in Taiwan

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.

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 groups in NCT04560842
Study groupRoleWhat they receive
Conventional oxygen deviseExperimentalChose devise to keep patient's SpO2 > 92%
Receives: Device: Conventional oxygen therapy
High flow nasal cannulaActive comparatorHigh 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.

  1. Intubation rate

    How many patients intubate in a year.

    Measured: A year

Secondary outcomes (4)
  1. Hospital days

    The number of days in hospital

    Measured: A year

  2. ICU days

    The number of days in ICU

    Measured: A year

  3. ICU mortality

    ICU mortality

    Measured: A year

  4. 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.

  1. First posted23 Sep 2020
  2. Study start25 Sep 2020 (estimated)
  3. Primary completion24 Sep 2021 (estimated)
  4. Study completion24 Sep 2021 (estimated)

Resources

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)
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

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.

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