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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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:
    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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
ClinicalTrials.gov Identifier: NCT00824096     History of Changes
Other Study ID Numbers: CM-IRB09512014
Study First Received: January 14, 2009
Last Updated: January 15, 2009
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%

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

ClinicalTrials.gov processed this record on August 27, 2014