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

High Flow Oxygen Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06357390
• Other study ID #: 202106174RINB
• Status: Completed
• Start date: October 7, 2021
• Est. completion date: February 15, 2024

Study information

• Verified date: July 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 15, 2024
• Est. primary completion date: July 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• High Flow Oxygen Therapy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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