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Use Bronchoscopy to Predict Post-Extubation Stridor in Critical Ill Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Chimei Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00824096
First Posted: January 16, 2009
Last Update Posted: January 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chimei Medical Center
  Purpose
Our study aims at the accuracy of bronchoscopy to predict PES. Evidence base medicine guidelines for extubation may be obtained through this study.

Condition Intervention
Post-Extubation Stridor Procedure: Bronchoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Further study details as provided by Chimei Medical Center:

Primary Outcome Measures:
  • The accuracy of bronchoscopy to predict post-extubation stridor. [ Time Frame: 48 hours ]

Estimated Enrollment: 100
Study Start Date: December 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Bronchoscopy
    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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Open T.B.
  • Bleeding tendency/ Platelet less than 40 thousands
  • Subject or family refuse
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824096


Contacts
Contact: Kuo-Chen Cheng 886-6-281 2811 ext 57487 n940721@mail.chimei.org.tw

Locations
Taiwan
Department of Intensive Care Medicine; Chi Mei Medical Center Recruiting
Tainan, Taiwan, 710
Principal Investigator: Kuo-Chen Cheng         
Sponsors and Collaborators
Chimei Medical Center
  More Information

Responsible Party: Kuo-Chen Cheng
ClinicalTrials.gov Identifier: NCT00824096     History of Changes
Other Study ID Numbers: CM-IRB09512014
First Submitted: January 14, 2009
First Posted: January 16, 2009
Last Update Posted: January 16, 2009
Last Verified: January 2009

Keywords provided by Chimei Medical Center:
endotracheal intubation
cuff-leak test
post-extubation stridor
bronchoscopy
corticosteroids
Cuff-leak volume less than 24%

Additional relevant MeSH terms:
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms