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

NCT06357390 | Completed

• 1 other identifier: 202106174RINB
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

High Flow Oxygen Therapy

Outcome Measures

Primary Outcomes (1)

• ventilation perfusion distribution measurement

  1. Within 2 hours before starting the whole day of ATC, start measuring lung volume and ventilation perfusion distribution in SIMV+PS mode. 2. Start the 72-hour ATC mode, measure once within 2 hours; measure again after 24 hours. 3. 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. 4. 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. 5. After the use of high flow oxygen starts, measure it every 24 hours until the 5th day.

  16 weeks

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Officials

• Jih-Shuin Jerng, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: April 10, 2024
• Study Start: October 7, 2021
• Primary Completion: July 25, 2022
• Study Completion: February 15, 2024
• Last Updated: April 10, 2024

Record last verified: 2023-07

Locations

TW (1)