Use Bronchoscopy to Predict Post-Extubation Stridor in Critical Ill Patients
Primary Purpose
Post-Extubation Stridor
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Bronchoscopy
Sponsored by
About this trial
This is an interventional prevention trial for Post-Extubation Stridor focused on measuring endotracheal intubation, cuff-leak test, post-extubation stridor, bronchoscopy, corticosteroids, Cuff-leak volume less than 24%
Eligibility 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
Sites / Locations
- Department of Intensive Care Medicine; Chi Mei Medical CenterRecruiting
Outcomes
Primary Outcome Measures
The accuracy of bronchoscopy to predict post-extubation stridor.
Secondary Outcome Measures
Full Information
NCT ID
NCT00824096
First Posted
January 14, 2009
Last Updated
January 15, 2009
Sponsor
Chimei Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00824096
Brief Title
Use Bronchoscopy to Predict Post-Extubation Stridor in Critical Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Chimei Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our study aims at the accuracy of bronchoscopy to predict PES. Evidence base medicine guidelines for extubation may be obtained through this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Extubation Stridor
Keywords
endotracheal intubation, cuff-leak test, post-extubation stridor, bronchoscopy, corticosteroids, Cuff-leak volume less than 24%
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The accuracy of bronchoscopy to predict post-extubation stridor.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuo-Chen Cheng
Phone
886-6-281 2811
Ext
57487
Email
n940721@mail.chimei.org.tw
Facility Information:
Facility Name
Department of Intensive Care Medicine; Chi Mei Medical Center
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuo-Chen Cheng
12. IPD Sharing Statement
Learn more about this trial
Use Bronchoscopy to Predict Post-Extubation Stridor in Critical Ill Patients
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