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Completed

NCT Number: NCT06357390

Physiologic and Clinical Effect of High-flow Oxygen Therapy in Tracheostomized Patients With Prolonged Mechanical Ventilation Undergoing Weaning Trials

This study is aimed at patients who have been admitted to the respiratory care center of this hospital who meet the PMV conditions (defined as continuous use of the ventilator for at least ten days) who are about to receive the ventilator out of training. After obtaining the explanatory consent, they will undergo continuous complete Before and after spontaneous breathing training, collect various relevant physiological data of lung volume and ventilation perfusion distribution, and analyze and predict the correlation of ventilator detachment.

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Key information

Conditions

High Flow Oxygen Therapy

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be at least 20 years old, have undergone tracheotomy, have been using a ventilator for at least 10 days, and have stable vital signs.

Exclusion criteria

  • Age <20 years
  • The oxygen concentration (FiO2) provided by the respirator exceeds 60%
  • pregnant
  • Blood pressure-systolic blood pressure below 70 mmHg
  • Heartbeat is lower than 50/min or higher than 160/min
  • Respiration rate is higher than 50/min
  • Lack of voluntary breathing

Treatment and study plan

Primary outcomes

  1. ventilation perfusion distribution measurement

    Time frame: 16 weeks

    • Within 2 hours before starting the whole day of ATC, start measuring lung volume and ventilation perfusion distribution in SIMV+PS mode.
    • Start the 72-hour ATC mode, measure once within 2 hours; measure again after 24 hours.
    • Within 2 hours before and after the completion of the 72-hour ATC conversion to the 24-hour tracheostomy tube high flow oxygen, one measurement is made.
    • Measure once within 2 hours before and after the completion of 24-hour high-flow oxygen conversion to 5 consecutive days of spontaneous breathing training.
    • After the use of high flow oxygen starts, measure it every 24 hours until the 5th day.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Apr 10, 2024
Registry last updated
Apr 10, 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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