The Effectiveness of High-flow Nasal Cannula After Extubation in Patients

December 23, 2024 updated by: Lo Tzu Han, Chang Gung Memorial Hospital

Observe the current status of prolonged mechanical ventilation (PMV) patients using high-flow nasal cannula oxygen therapy (experimental group) or traditional oxygen therapy (control group) after extubation, and compare the differences in ventilator weaning rates between the two groups.

Record the ROX index (SpO2/FiO2/RR) at 2, 6, 12, and 24 hours after extubation in PMV patients and explore whether statistical methods can predict the weaning outcome within seven days.

Use statistical methods to analyze whether comorbidities in the PMV population affect ventilator weaning rates.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

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

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Kaohsiung Chang Gung Memorial 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Sample Size: The sample size was calculated using the G Power statistical software with a chi-square test. Parameters used were effect size: 0.3, alpha: 0.05, and power: 0.8. Based on these conditions, the required sample size is estimated to be 88 participants.

Experimental Group: Comprising 44 PMV (Prolonged Mechanical Ventilation) patients who, after extubation, are assessed by physicians to use high-flow nasal cannula oxygen therapy.

Control Group: Comprising 44 PMV patients who, after extubation, are assessed by physicians to use traditional oxygen therapy.

Description

Inclusion Criteria:

  • Patients over 20 years old and expected to undergo extubation.

Exclusion Criteria:

  • Patients with tracheostomy who will use non-invasive or invasive ventilators immediately after extubation.

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

Cohorts and Interventions

Group / Cohort
HFNC group
HFNC support post extubation
oxygen therapy
oxygen therapy post extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
P/F ratio
Time Frame: From enrollment to preliminary data compilation, lasting a total of 4 months.
Collect the arterial oxygen partial pressure (PaO₂, mmHg) from each patient's clinical arterial blood dialysis, and compare it with the oxygen concentration (%) being used at the time. The two values are then combined to calculate the P/F ratio (PaO₂, mmHg / FiO₂, decimal).
From enrollment to preliminary data compilation, lasting a total of 4 months.
ROX index
Time Frame: From enrollment to preliminary data compilation, lasting a total of 4 months.
The oxygen concentration used before and after oxygen therapy adjustment is recorded as percent, accompanied by clinical and physiological parameter the patient's oxygen saturation (SpO₂) and respiratory rate (breaths per minute). Additionally, multiple measurements of the ROX index are performed, combining saturation (SpO₂), FiO₂, and respiratory rate to calculate and report the ROX index (SpO₂ / FiO₂ / RR).
From enrollment to preliminary data compilation, lasting a total of 4 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under Curve (AUC)
Time Frame: From enrollment to the end of treatment at 1.5 year

he Area Under the Curve (AUC) quantifies the overall performance of a model. The AUC ranges from 0 to 1, where an AUC of 0.5 indicates no discriminative power (random guessing), and an AUC of 1.0 indicates perfect discrimination that distinguishes between positive and negative classes without error.

A higher AUC value suggests better model performance in distinguishing between classes, making it a widely used measure for assessing predictive accuracy in clinical and research datasets.
From enrollment to the end of treatment at 1.5 year
Receiver Operating Characteristic (ROC) curve
Time Frame: From enrollment to the end of treatment at 1.5 year
the Receiver Operating Characteristic (ROC) curve, the performance of two predictive models, Logistic Regression and Random Forest, in predicting HFNC (High-Flow Nasal Cannula) weaning success. The curve plots the True Positive Rate (Sensitivity) on the y-axis against the False Positive Rate (1 - Specificity) on the x-axis across various classification thresholds.
From enrollment to the end of treatment at 1.5 year

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial 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)

June 15, 2022

Primary Completion (Actual)

January 15, 2024

Study Completion (Actual)

March 20, 2024

Study Registration Dates

First Submitted

November 29, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202200799B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

this study is the result of collaborative efforts by co-researchers.

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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