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

Post-Extubation Stridor Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00824096
• Other study ID #: CM-IRB09512014
• Status: Unknown status
• Phase: N/A
• First received: January 14, 2009
• Last updated: January 15, 2009
• Start date: December 2006
• Est. completion date: December 2009

Study information

• Verified date: January 2009
• Source: Chimei Medical Center
• Contact: Kuo-Chen Cheng
• Phone: 886-6-281 2811
• Email: n940721[@]mail.chimei.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our study aims at the accuracy of bronchoscopy to predict PES. Evidence base medicine guidelines for extubation may be obtained through this study.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-Extubation Stridor
• Respiratory Sounds

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Department of Intensive Care Medicine; Chi Mei Medical Center	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
Chimei Medical Center

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy of bronchoscopy to predict post-extubation stridor.		48 hours