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Completed

NCT Number: NCT06746363

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

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.

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Key information

Conditions

Post Extubation Respiratory Failure

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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).

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 24, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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