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

NCT00824096 | Unknown

• 1 other identifier: CM-IRB09512014
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Extubation Stridor

Keywords

endotracheal intubation; cuff-leak test; post-extubation stridor; bronchoscopy; corticosteroids; Cuff-leak volume less than 24%

Outcome Measures

Primary Outcomes (1)

• The accuracy of bronchoscopy to predict post-extubation stridor.

  48 hours

Interventions

Bronchoscopy PROCEDURE

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chimei Medical Center: lead

Study Sites (1)

Department of Intensive Care Medicine; Chi Mei Medical Center

Tainan, 710, Taiwan

RECRUITING

MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Central Study Contacts

Kuo-Chen Cheng

CONTACT

886-6-281 2811; n940721@mail.chimei.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 16, 2009
• Study Start: December 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 16, 2009

Record last verified: 2009-01

Locations

TW (1)