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Flow Rates of High-flow Nasal Cannula and Extubation Outcome

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ClinicalTrials.gov Identifier: NCT04934163
Recruitment Status : Recruiting
First Posted : June 22, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
This is a single-center, open-label, randomized controlled trial to evaluate the effect of high-flow nasal cannula with a flow rate of 60 L/min versus 40 L/min after planned extubationon on a composite outcome of reintubation and use of NIV.

Condition or disease Intervention/treatment Phase
Hypoxemic Respiratory Failure Other: Flow rate setting of high-flow nasal cannula (initially 60L/min) Other: Flow rate setting of high-flow nasal cannula (initially 40L/min) Not Applicable

Detailed Description:

This is a single-center, open-label, randomized controlled trial to evaluate the effect of high-flow nasal cannula with a flow rate of 60 L/min versus 40 L/min after planned extubationon on a composite outcome of reintubation and use of NIV in patients who are intubated for hypoxemic respiratory failure.

[Study Procedures] Set flow rates of HFNC The flow rates of HFNC(high-flow nasal cannula) are set as 40 L/min and 60 L/min, respectively in the two trial groups. Initial FiO2 setting is 100%, which would be titrated down to the minimal level to keep SO2 ≥ 92% within 30 minutes after extubation. After that, the flow rate setting is fixed for 24hrs +/- 6 hrs in the two groups. After that, the flow rate setting in both groups would be tapered to 30 L/min and would be kept for 12 hours. Then, HFNC would be changed to conventional oxygen therapy to keep SpO2≥ 92%.

[Outcome Measures] To increase the statistical power of this pilot trial, we used a composite outcome of NIV use and or reintubation in 48 hours for the primary endpoint. Secondary endpoints include mortality of different time points, physiological parameters(respiratory rate, heart rate), ventilation/oxygenation data(PaO2/FiO2 ratio, pH) and patient comfort. Exploratory endpoints include comparison between different flow rate settings.

[Primary endpoint] We hypothesized that higher flow setting of HFNC can reduce work of breathing and can increase washout of dead space, which could result in lower re-intubation rate and lower NIV use rate after planned extubation in hypoxemic patients. The primary endpoint is a composite outcome of NIV use or reintubation in 48 hours between two groups of different flow rates.

[Secondary endpoints] ICU mortality In-hospital mortality 28-day mortality Time to successful liberation from mechanical ventilation AUC(area under curve) of respiratory rate (0-24 hours) AUC of heart rate (0-24 hours) PaO2/FiO2 ratio at 4 and 24 hours Change of arterial CO2 level(mmHg) at 4 and 24 hours Proportion of respiratory acidosis (arterial blood gas: pH<7.35) at 4 and 24 hours Proportion of Intolerance at 4 and 24 hours Patient comfort (measured by Visual Analog Scale) at 24 hours

[Sample size] The event rate of primary endpoint, defined as a composite outcome of NIV use and or reintubation in 48 hours, was assumed to be 40% in the 40 L/min arms and 25% in the 60 L/min. We estimated that with a sample of 165 patients, the study would have 80% power to detect a 15% absolute reduction in proportion of composite outcomes, at a two-sided type I error rate of 5%.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Flow Rates of Postextubation High-flow Nasal Cannula on Extubation Outcome: An Open-label, Randomized Controlled Trial
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : May 31, 2023

Arm Intervention/treatment
Experimental: 60 L/min arm
The flow rate of HFNC(high-flow nasal cannula) is set as 60 L/min after extubation.
Other: Flow rate setting of high-flow nasal cannula (initially 60L/min)

The flow rates of HFNC(high-flow nasal cannula) is set as 60L/min(temperature:34°C).

Initial FiO2 is 100%, which would be titrated down to the minimal level to keep SpO2 ≥ 92% within 30 minutes after extubation.

After that, the flow rate setting is fixed for 24hrs +/- 6 hrs; then, is tapered to 30 L/min and kept for 12 more hours. Afterwards, HFNC would be changed to conventional oxygen therapy to keep SpO2≥ 92%.


Experimental: 40 L/min arm
The flow rate of HFNC(high-flow nasal cannula) is set as 40 L/min after extubation.
Other: Flow rate setting of high-flow nasal cannula (initially 40L/min)

The flow rates of HFNC(high-flow nasal cannula) is set as 40L/min(temperature:34°C).

Initial FiO2 is 100%, which would be titrated down to the minimal level to keep SpO2 ≥ 92% within 30 minutes after extubation.

After that, the flow rate setting is fixed for 24hrs +/- 6 hrs; then, is tapered to 30 L/min and kept for 12 more hours. Afterwards, HFNC would be changed to conventional oxygen therapy to keep SpO2≥ 92%.





Primary Outcome Measures :
  1. A composite outcome of NIV(non-invasive ventilation) use or reintubation in 48 hours [ Time Frame: 48 hours after extubation ]
    Proportion of patients require NIV(non-invasive ventilation) support or reintubation


Secondary Outcome Measures :
  1. ICU mortality [ Time Frame: ICU stay ]
    Proportion of death in the ICU

  2. In-hospital mortality [ Time Frame: Hospital stay ]
    Proportion of death in the hospital

  3. 28-day mortality [ Time Frame: 28 days ]
    Proportion of death in 28 days after extubation

  4. Time to successful liberation from mechanical ventilation [ Time Frame: 28 days ]
    Definition of successful liberation from mechanical ventilation: not requiring mechanical ventilation support for > 48 hours

  5. AUC(area under curve) of respiratory rate (0-24 hours) [ Time Frame: 24 hours ]
    measure respiratory rate every 2 hours during HFNC use

  6. AUC of heart rate (0-24 hours) [ Time Frame: 24 hours ]
    measure heart rate every 2 hours during HFNC use

  7. PaO2/FiO2 ratio at 4 and 24 hours [ Time Frame: 24 hours ]
    PaO2: from arterial blood gas; FiO2:from HFNC setting

  8. Change of arterial CO2 level(mmHg) at 4 and 24 hours [ Time Frame: 24 hours ]
    CO2 level

  9. Proportion of respiratory acidosis (arterial blood gas: pH<7.35) at 4 and 24 hours [ Time Frame: 24 hours ]
    Respiratory acidosis

  10. Proportion of Intolerance at 4 and 24 hours [ Time Frame: 24 hours ]
    subjective intolerance (Eg. temperature setting, flow setting, interface....)

  11. Patient comfort score at 24 hour [ Time Frame: 24 hours ]
    7-point scale which 7 indicates most comfortable and 1 indicates least comfortable



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • invasive mechanical ventilation > 48 hours
  • acute hypoxemic respiratory failure(PaO2/FiO2 < 300 mmHg) as a main cause of invasive mechanical ventilation.
  • planned extubation & already passed a spontaneous breathing trial (SBT)

Exclusion Criteria:

  • < 20 years of ages
  • refusal to re-intubation
  • with terminal cancer
  • pregnant women
  • with a tracheal stoma or tracheostomy tube in situ
  • not feasible for high-flow nasal cannula(decided by the primary care team)
  • must required to use non-invasive ventilation immediately after extubation (decided by the primary care team)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04934163


Contacts
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Contact: Sheng-Yuan Ruan, MD 886-2-23123456 syruan@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Sheng-Yuan Ruan, MD       syruan@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Director: Daniel Fu-Chang Tsai, MD, PhD Research Ethics Committee of the National Taiwan University Hospital
Publications of Results:

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04934163    
Other Study ID Numbers: 202103054RINB
First Posted: June 22, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
high-flow nasal cannula
hypoxemic respiratory failure
oxygen therapy
postextubation respiratory failure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases