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.

Study Overview

• Status: Completed
• Conditions: High Flow Oxygen Therapy

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who were transferred to RCC and tried to get out of the ventilator after tracheotomy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ventilation perfusion distribution measurement	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.	16 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Jih-Shuin Jerng, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Actual): July 25, 2022
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 202106174RINB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No