Post-Extubation StridorNCT00824096
Use Bronchoscopy to Predict Post-Extubation Stridor in Critical Ill Patients
A study testing Bronchoscopy in people with Post-Extubation Stridor, run by Chimei Medical Center at 1 site in Taiwan.
Trial summary
Our study aims at the accuracy of bronchoscopy to predict PES. Evidence base medicine guidelines for extubation may be obtained through this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Extubation Stridor
- What is being tested?
- Bronchoscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2006to Dec 2009
- Phase
- Interventional
- 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
Who may be able to join
- Age equal or greater than 18 years old
- Intubation over 24 hrs
- Match weaning profile
- Cuff leak volume less than 24%
- VS and subject/family agree
Who cannot join
- Re-Intubation
- History of upper air way obstruction
- Severe CV disease (ex. AMI)
- Active UGI Bleeding
- Blood sugar persistent more than 250 mg/dl under medication control
- Risk of IICP
Show all 9Show fewer
- Open T.B.
- Bleeding tendency/ Platelet less than 40 thousands
- Subject or family refuse
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Intensive Care Medicine; Chi Mei Medical Center
Tainan, 710
Kuo-Chen Cheng
About this study
Our study aims at the accuracy of bronchoscopy to predict PES. Evidence base medicine guidelines for extubation may be obtained through this study.
- Conditions
- Post-Extubation Stridor
- Being tested
- Bronchoscopy
- Keywords
- endotracheal intubation, cuff-leak test, post-extubation stridor, bronchoscopy, corticosteroids, Cuff-leak volume less than 24%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyProcedure or surgery
The patients in our ICU intubated for > 24h and met weaning criteria, will be examined by bronchoscopy. Five ㏄ blood will be collected for checking CRP and cytokines before performing bronchoscopy. The proposed grading of post-extubation vocal cord finding were shown (Figure 1). The patients will be classified to two groups (Figure 2). The first group is these patients without swelling or swelling area ≦50% who will be extubated after bronchoscopic examination. These patients will be followed for 48 hours to monitor the incidence of PES. The second group is those patients who develop laryngeal edema with swelling area ≧50% or swelling in the whole vocal cord. Bosmin 2 ml local injection and Solu-medrol 40 mg I.V. Q6h for 1~4 days will be given. Bronchoscopy will be done if CLV ≧24% or after treatments for 3~4 days even with CLV <24%. The above treatments will be applied again if stridor develops. Extubation will be performed if no presence of laryngeal edema.
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of bronchoscopy to predict post-extubation stridor.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startDec 2006
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Extubation StridorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824096
- Sponsor's protocol ID
- CM-IRB09512014
- Status last verified
- Jan 2009
- First submitted
- 14 Jan 2009
- Last updated
- 16 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Bronchoscopy to Predict Post-Extubation Stridor in Critical Ill Patients
- ClinicalTrials.gov ID
- NCT00824096
- Acronym / sponsor ID
- CM-IRB09512014
- Conditions
- Post-Extubation Stridor
- Keywords
- endotracheal intubation, cuff-leak test, post-extubation stridor, bronchoscopy, corticosteroids, Cuff-leak volume less than 24%
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 16 Jan 2009 (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.
Our study aims at the accuracy of bronchoscopy to predict PES. Evidence base medicine guidelines for extubation may be obtained through this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age equal or greater than 18 years old
- Intubation over 24 hrs
- Match weaning profile
- Cuff leak volume less than 24%
- VS and subject/family agree
Key exclusion criteria (9 listed)
- Re-Intubation
- History of upper air way obstruction
- Severe CV disease (ex. AMI)
- Active UGI Bleeding
- Blood sugar persistent more than 250 mg/dl under medication control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BronchoscopyThe patients in our ICU intubated for > 24h and met weaning criteria, will be examined by bronchoscopy. Five ㏄ blood will be collected for checking CRP and cytokines before performing bronchoscopy. The proposed grading of post-extubation vocal cord finding were shown (Figure 1). The patients will be classified to two groups (Figure 2). The first group is these patients without swelling or swelling area ≦50% who will be extubated after bronchoscopic examination. These patients will be followed for 48 hours to monitor the incidence of PES. The second group is those patients who develop laryngeal edema with swelling area ≧50% or swelling in the whole vocal cord. Bosmin 2 ml local injection and Solu-medrol 40 mg I.V. Q6h for 1~4 days will be given. Bronchoscopy will be done if CLV ≧24% or after treatments for 3~4 days even with CLV <24%. The above treatments will be applied again if stridor develops. Extubation will be performed if no presence of laryngeal edema. | Procedure or surgery | – |
Primary outcome
The accuracy of bronchoscopy to predict post-extubation stridor.
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy in people with Post-Extubation Stridor, run by Chimei Medical Center 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 5 inclusion and 9 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 16 Jan 2009. 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 Kuo-Chen Cheng (886-6-281 2811 ext. 57487, n940721@mail.chimei.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of bronchoscopy to predict post-extubation stridor. (time frame: 48 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 16 Jan 2009.