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

NCT ID: NCT00824096

Last Updated: 2009-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-Extubation Stridor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chimei Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kuo-Chen Cheng

Locations

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Department of Intensive Care Medicine; Chi Mei Medical Center

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Kuo-Chen Cheng

Role: CONTACT

886-6-281 2811 ext. 57487

Other Identifiers

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CM-IRB09512014

Identifier Type: -

Identifier Source: org_study_id

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