MortalityNCT05905042
Follow-up of Recovery Condition in Survivors of Acute Respiratory Distress Syndrome
An observational study of Mortality, run by Chimei Medical Center.
Trial summary
Hope to realize the recovery condition of ARDS survivors in Taiwan. It would be helpful not only to design the proper rehabilitation program but also to be a useful reference for the poor recovery patients to take hospice care if indicated. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Mortality
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Feb 2016
- How long will I take part?
- 1 Year
- 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: ARDS patients
Who may be able to join
- ARDS patients
Who cannot join
- NA
About this study
Hope to realize the recovery condition of ARDS survivors in Taiwan. It would be helpful not only to design the proper rehabilitation program but also to be a useful reference for the poor recovery patients to take hospice care if indicated.
Read the detailed description
This study will enroll the participant met the diagnostic criteria of ARDS. The basic data, clinical manifestations, laboratory data and outcomes of participants will be recorded.
And the investigator will also follow up the pulse oximeter, peak expiratory flow rate, six-minute walk test and health-related quality of life measures with SF-36 in 3, 6 and 12 months after the participants were discharged from the ICU. Through this study, the investigator hope to realize the recovery condition of ARDS survivors in Taiwan.
It would be helpful not only to design the proper rehabilitation program but also to be a useful reference for the poor recovery patients to take hospice care if indicated.
- Conditions
- Mortality
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of postextubation stridor
To determine whether treatment with corticosteroids decreases the incidence of postextubation airway obstruction in an adult intensive care unit.
Measured: 24 hours
Secondary outcomes (1)
The actual tidal volume at expiration
The actual tidal volume at expiration was measured before and after deflation of the endotracheal tube cuff as previously described (9). The difference in the actual tidal volume before and after cuff deflation was defined as the cuff leak volume (CLV).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study startSep 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MortalityStudies of the same condition, open and under way.
- 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
- 1 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuo-Chen Cheng, Chimei Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905042
- Sponsor's protocol ID
- CMFHR10362(IRB10308-011)
- Status last verified
- Jun 2023
- First submitted
- 24 Jan 2018
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Recovery Condition in Survivors of Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05905042
- Acronym / sponsor ID
- CMFHR10362(IRB10308-011)
- Conditions
- Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 15 Jun 2023 (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.
Hope to realize the recovery condition of ARDS survivors in Taiwan. It would be helpful not only to design the proper rehabilitation program but also to be a useful reference for the poor recovery patients to take hospice care if indicated.
Detailed description
This study will enroll the participant met the diagnostic criteria of ARDS. The basic data, clinical manifestations, laboratory data and outcomes of participants will be recorded.
And the investigator will also follow up the pulse oximeter, peak expiratory flow rate, six-minute walk test and health-related quality of life measures with SF-36 in 3, 6 and 12 months after the participants were discharged from the ICU. Through this study, the investigator hope to realize the recovery condition of ARDS survivors in Taiwan.
It would be helpful not only to design the proper rehabilitation program but also to be a useful reference for the poor recovery patients to take hospice care if indicated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ARDS patients
Key inclusion criteria (1 listed)
- ARDS patients
Key exclusion criteria (1 listed)
- NA
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
occurrence of postextubation stridor
Time frame: 24 hours
To determine whether treatment with corticosteroids decreases the incidence of postextubation airway obstruction in an adult intensive care unit.
1 secondary outcome
The actual tidal volume at expiration
Time frame: 24 hours
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 15 Jun 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mortality, run by Chimei Medical Center.
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 1 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 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
occurrence of postextubation stridor (time frame: 24 hours). 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 15 Jun 2023.