Flow Rates of High-flow Nasal Cannula and Extubation Outcome

August 8, 2023 updated by: National Taiwan University Hospital

Effect of Flow Rates of Postextubation High-flow Nasal Cannula on Extubation Outcome: An Open-label, Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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%.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours after extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU mortality
Time Frame: ICU stay
Proportion of death in the ICU
ICU stay
In-hospital mortality
Time Frame: Hospital stay
Proportion of death in the hospital
Hospital stay
28-day mortality
Time Frame: 28 days
Proportion of death in 28 days after extubation
28 days
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
28 days
AUC(area under curve) of respiratory rate (0-24 hours)
Time Frame: 24 hours
measure respiratory rate every 2 hours during HFNC use
24 hours
AUC of heart rate (0-24 hours)
Time Frame: 24 hours
measure heart rate every 2 hours during HFNC use
24 hours
Change of PaO2/FiO2 ratio between 0 and 24th hour
Time Frame: 24 hours
PaO2: from arterial blood gas; FiO2:from HFNC setting
24 hours
Change of arterial CO2 level(mmHg) between 0 and 24th hour
Time Frame: 24 hours
CO2 level
24 hours
Proportion of respiratory acidosis (arterial blood gas: pH<7.35) in 24 hours
Time Frame: 24 hours
Respiratory acidosis
24 hours
Proportion of Intolerance in 24 hours
Time Frame: 24 hours
subjective intolerance (Eg. temperature setting, flow setting, interface....)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: Daniel Fu-Chang Tsai, MD, PhD, Research Ethics Committee of the National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

March 28, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202103054RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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