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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Chimei Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chimei Medical Center
ClinicalTrials.gov Identifier:
NCT00824096
First received: January 14, 2009
Last updated: January 15, 2009
Last verified: January 2009

January 14, 2009
January 15, 2009
December 2006
December 2009   (final data collection date for primary outcome measure)
The accuracy of bronchoscopy to predict post-extubation stridor. [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00824096 on ClinicalTrials.gov Archive Site
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Use Bronchoscopy to Predict Post-Extubation Stridor in Critical Ill Patients
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Our study aims at the accuracy of bronchoscopy to predict PES. Evidence base medicine guidelines for extubation may be obtained through this study.

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Interventional
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Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Post-Extubation Stridor
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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Kuo-Chen Cheng 886-6-281 2811 ext 57487 n940721@mail.chimei.org.tw
Taiwan
 
NCT00824096
CM-IRB09512014
No
Kuo-Chen Cheng
Chimei Medical Center
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Chimei Medical Center
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP