Respiratory FailureNCT00683072
Patient-Ventilator Dyssynchrony: How is the Effect of Management?
An observational study of Respiratory Failure, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Although patient-ventilator asynchrony is a frequent phenomenon, its course following management is unknown. As the aid of a data recording system, we try to observe the consequence of patient-ventilator asynchrony following management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2008to Dec 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Between March 2008 through December 2008, patients admitted to our respiratory intensive care unit for the management of acute respiratory failure were daily screened for the presence of patient-ventilator asynchrony.
Who may be able to join
- patients admitted to respiratory intensive care unit with acute respiratory failure and presence of patient-ventilator asynchrony(AI of more than 10%)
- patient can trigger the ventilator
Who cannot join
- High oxygen fraction: > 60%.
- High PEEP need: > 12cmH2O.
- Hemodynamic unstable: shock
- Central nervous system problem.
- Hyperacitve delirium
- Without informed consent
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan, 704
Kuang Ming Liao, MD, 886-6-235-3535 ext. 2588, abc8870@yahoo.com.tw
About this study
Although patient-ventilator asynchrony is a frequent phenomenon, its course following management is unknown. As the aid of a data recording system, we try to observe the consequence of patient-ventilator asynchrony following management. Our target is aimed at the patients with high asynchronization index ( > 10%) as this group of patients have been shown to have prolonged course in intensive care unit and are also prone to be tracheostomized
- Conditions
- Respiratory Failure
- Keywords
- Ventilator, patient-ventilator asynchrony
- Medical subject headings
- Respiratory Insufficiency, Patient-Ventilator Asynchrony
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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asynchrony index (AI). (Number of asynchrony events/total respiratory rate)
Measured: 20 minutes after alternation of ventilator settings or any therapeutic means
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chang wen Chen, MD, MS, Study director, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683072
- Sponsor's protocol ID
- NCKUH-9703023
- Status last verified
- May 2008
- First submitted
- 21 May 2008
- Last updated
- 23 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Ventilator Dyssynchrony: How is the Effect of Management?
- ClinicalTrials.gov ID
- NCT00683072
- Acronym / sponsor ID
- NCKUH-9703023
- Conditions
- Respiratory Failure
- Keywords
- Ventilator, patient-ventilator asynchrony
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 23 May 2008 (estimated)
- 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.
Although patient-ventilator asynchrony is a frequent phenomenon, its course following management is unknown. As the aid of a data recording system, we try to observe the consequence of patient-ventilator asynchrony following management. Our target is aimed at the patients with high asynchronization index ( > 10%) as this group of patients have been shown to have prolonged course in intensive care unit and are also prone to be tracheostomized
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between March 2008 through December 2008, patients admitted to our respiratory intensive care unit for the management of acute respiratory failure were daily screened for the presence of patient-ventilator asynchrony.
Key inclusion criteria (2 listed)
- patients admitted to respiratory intensive care unit with acute respiratory failure and presence of patient-ventilator asynchrony(AI of more than 10%)
- patient can trigger the ventilator
Key exclusion criteria (6 listed)
- High oxygen fraction: > 60%.
- High PEEP need: > 12cmH2O.
- Hemodynamic unstable: shock
- Central nervous system problem.
- Hyperacitve delirium
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
Asynchrony index (AI). (Number of asynchrony events/total respiratory rate)
Time frame: 20 minutes after alternation of ventilator settings or any therapeutic means
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2008.
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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.
Chang wen Chen, MD, MS study director
National Cheng-Kung 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 Respiratory Failure, run by National Cheng-Kung 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 May 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuang Ming Liao, MD (886-6-235-3535 ext. 2588, abc8870@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asynchrony index (AI). (Number of asynchrony events/total respiratory rate) (time frame: 20 minutes after alternation of ventilator settings or any therapeutic means). 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 23 May 2008.