Ventilator WeaningNCT03433105
Oxygen Uptake in Weaning of Patients From Prolonged Mechanical Ventilation
An observational study of Ventilator Weaning, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
1.Research hypothesis: during weaning patient from prolonged mechanical ventilation, if the work load caused by weaning was below the patient's AT, oxygen uptake will be constant. Otherwise, if the work load was above the patient's AT, the oxygen uptake will increase. 1. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Ventilator Weaning
- How many people
- 157 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Jan 2018to 14 Aug 2020
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who have tracheostomy tubes and with prolonged mechanical ventilation
- Inclusion criteria: Adult >20 y/o Total duration of mechanical ventilation ≥ 10 days Received tracheostomy Defervescence Meeting the criteria of weaning phase (see supplementary protocols)
- Exclusion criteria FiO2 >50 % Unstable hemodynamics Fever with active infection No spontaneous respiratory drive Dynamic airway collapse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Investigate the Prognostic Value of Oxygen Uptake in Weaning of Patients From Prolonged Mechanical Ventilation
1.Research hypothesis: during weaning patient from prolonged mechanical ventilation, if the work load caused by weaning was below the patient's AT, oxygen uptake will be constant. Otherwise, if the work load was above the patient's AT, the oxygen uptake will increase.
- Patient: who have tracheostomy tubes and with prolonged mechanical ventilation
- Measurement: oxygen uptake(V̇O2) and respiratory mechanics during the spontaneous breathing trials
- Outcome: Correlation between the oxygen uptake(V̇O2) and the weaning outcome
Read more
2.Specific aims:
- to investigate the prognostic value of oxygen uptake in weaning patients from prolonged mechanical ventilation
- Subgroup analysis may suggest which weaning protocol potentially benefit the most for each population group (cardiovascular disease, chronic pulmonary disease, neuromuscular disease, cerebrovascular disease)
- Conditions
- Ventilator Weaning
- Keywords
- oxygen uptake, prolonged mechanical ventilation, weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/patients with tracheostomy tubes and prolonged MV use | Patients who have tracheostomy tubes and with prolonged mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of oxygen uptake (V̇O2)
oxygen uptake during the spontaneous breathing trial
Measured: up to 12 hours during the spontaneous breathing trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start23 Jan 2018
- Primary completion14 Aug 2020
- Study completion14 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator WeaningStudies 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
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yao-Wen Kuo, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433105
- Sponsor's protocol ID
- 201710003RINB
- Status last verified
- Sep 2019
- First submitted
- 23 Jan 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Prognostic Value of Oxygen Uptake in Weaning of Patients From Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03433105
- Acronym / sponsor ID
- 201710003RINB
- Conditions
- Ventilator Weaning
- Keywords
- oxygen uptake, prolonged mechanical ventilation, weaning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 14 Aug 2020 (actual)
- First posted
- 14 Feb 2018 (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.
1.Research hypothesis: during weaning patient from prolonged mechanical ventilation, if the work load caused by weaning was below the patient's AT, oxygen uptake will be constant. Otherwise, if the work load was above the patient's AT, the oxygen uptake will increase.
- Patient: who have tracheostomy tubes and with prolonged mechanical ventilation
- Measurement: oxygen uptake(V̇O2) and respiratory mechanics during the spontaneous breathing trials
- Outcome: Correlation between the oxygen uptake(V̇O2) and the weaning outcome
2.Specific aims:
- to investigate the prognostic value of oxygen uptake in weaning patients from prolonged mechanical ventilation
- Subgroup analysis may suggest which weaning protocol potentially benefit the most for each population group (cardiovascular disease, chronic pulmonary disease, neuromuscular disease, cerebrovascular disease)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/patients with tracheostomy tubes and prolonged MV use | – | –Patients who have tracheostomy tubes and with prolonged mechanical ventilation |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who have tracheostomy tubes and with prolonged mechanical ventilation
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
Measurement of oxygen uptake (V̇O2)
Time frame: up to 12 hours during the spontaneous breathing trial
oxygen uptake during the spontaneous breathing trial
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 8 Oct 2020.
Related trials for Ventilator Weaning
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Recruiting
A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System
Ventilator Induced Diaphragm Dysfunction
Not yet recruitingObservational study
Diaphragm Ultrasound and Rapid Shallow Breathing Index for Predicting Extubation Success
Ventilator Weaning, Respiratory Insufficiency
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Recruiting
Shenfu Injection for the Prevention and Treatment of Ventilator Dependence in Mechanically Ventilated Patients
Ventilator-induced Diaphragm Dysfunction, Ventilator Dependence
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.
Yao-Wen Kuo, 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 Ventilator Weaning, 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?
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 8 Oct 2020. 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?
Measurement of oxygen uptake (V̇O2) (time frame: up to 12 hours during the spontaneous breathing trial). 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 8 Oct 2020.