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

This study is currently recruiting participants.

Verified by Chimei Medical Center, January 2009

First Received: January 14, 2009 Last Updated: January 15, 2009 History of Changes

Sponsored by:	Chimei Medical Center
Information provided by:	Chimei Medical Center
ClinicalTrials.gov Identifier:	NCT00824096

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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 ] [ Designated as safety issue: Yes ]

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:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Kuo-Chen Cheng ( Kuo-Chen Cheng )
Study ID Numbers:	CM-IRB09512014
Study First Received:	January 14, 2009
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00824096 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by Chimei Medical Center:

endotracheal intubation
cuff-leak test
post-extubation stridor

bronchoscopy
corticosteroids
Cuff-leak volume less than 24%

Study placed in the following topic categories:

Methylprednisolone
Prednisolone
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone Hemisuccinate

ClinicalTrials.gov processed this record on May 07, 2009