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The Efficacy of High-flow Nasal Cannula Oxygen Therapy in Sepsis Patients

Primary Purpose

High Flow Nasal Cannula, Sepsis Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
A high flow oxygen device.
Conventional oxygen therapy
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for High Flow Nasal Cannula

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age older than 20 years.
  • Pneumonia definitions.
  • Diagnosis on admission was sepsis due to pneumonia or septic shock (Sepsis-3).

Exclusion Criteria:

  • 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。
  • 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)。

Sites / Locations

  • Mackay Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conventional oxygen devise

High flow nasal cannula

Arm Description

Chose devise to keep patient's SpO2 > 92%

High flow oxygen device

Outcomes

Primary Outcome Measures

Intubation rate
How many patients intubate in a year.

Secondary Outcome Measures

Hospital days
The number of days in hospital
ICU days
The number of days in ICU
ICU mortality
ICU mortality
Hospital mortality
Hospital mortality

Full Information

First Posted
September 17, 2020
Last Updated
September 22, 2020
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04560842
Brief Title
The Efficacy of High-flow Nasal Cannula Oxygen Therapy in Sepsis Patients
Official Title
The Efficacy of High-flow Nasal Cannula Oxygen Therapy in Sepsis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 25, 2020 (Anticipated)
Primary Completion Date
September 24, 2021 (Anticipated)
Study Completion Date
September 24, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Flow Nasal Cannula, Sepsis Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional oxygen devise
Arm Type
Experimental
Arm Description
Chose devise to keep patient's SpO2 > 92%
Arm Title
High flow nasal cannula
Arm Type
Active Comparator
Arm Description
High flow oxygen device
Intervention Type
Device
Intervention Name(s)
A high flow oxygen device.
Intervention Description
The HFNC group use high flow oxygen device for 48 hours
Intervention Type
Device
Intervention Name(s)
Conventional oxygen therapy
Intervention Description
Conventional oxygen device
Primary Outcome Measure Information:
Title
Intubation rate
Description
How many patients intubate in a year.
Time Frame
A year
Secondary Outcome Measure Information:
Title
Hospital days
Description
The number of days in hospital
Time Frame
A year
Title
ICU days
Description
The number of days in ICU
Time Frame
A year
Title
ICU mortality
Description
ICU mortality
Time Frame
A year
Title
Hospital mortality
Description
Hospital mortality
Time Frame
A year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age older than 20 years. Pneumonia definitions. Diagnosis on admission was sepsis due to pneumonia or septic shock (Sepsis-3). Exclusion Criteria: 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。 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)。
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuo Ping Tseng
Phone
886-989452824
Email
you_8012@hotmail.com
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuo Ping Tseng
Phone
886-989452824
Email
you_8012@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Efficacy of High-flow Nasal Cannula Oxygen Therapy in Sepsis Patients

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