High Flow Oxygen TherapyNCT06357390
Physiologic and Clinical Effect of High-flow Oxygen Therapy in Tracheostomized Patients With Prolonged Mechanical Ventilation Undergoing Weaning Trials
An observational study of High Flow Oxygen Therapy, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- High Flow Oxygen Therapy
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Oct 2021to 15 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were transferred to RCC and tried to get out of the ventilator after tracheotomy
Who may be able to join
- Be at least 20 years old, have undergone tracheotomy, have been using a ventilator for at least 10 days, and have stable vital signs.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start7 Oct 2021
- Primary completion25 Jul 2022
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Flow Oxygen TherapyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jih-Shuin Jerng, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357390
- Sponsor's protocol ID
- 202106174RINB
- Status last verified
- Jul 2023
- First submitted
- 29 Dec 2021
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic and Clinical Effect of High-flow Oxygen Therapy in Tracheostomized Patients With Prolonged Mechanical Ventilation Undergoing Weaning Trials
- ClinicalTrials.gov ID
- NCT06357390
- Acronym / sponsor ID
- 202106174RINB
- Conditions
- High Flow Oxygen Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were transferred to RCC and tried to get out of the ventilator after tracheotomy
Key inclusion criteria (1 listed)
- Be at least 20 years old, have undergone tracheotomy, have been using a ventilator for at least 10 days, and have stable vital signs.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ventilation perfusion distribution measurement
Time frame: 16 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jih-Shuin Jerng, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Flow Oxygen Therapy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventilation perfusion distribution measurement (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.