A Blind Maneuver to Position an Endobronchial Blocker

Thoracic Surgery Clinical Trial

Official title:

A Blind Maneuver to Position an Endobronchial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364142
• Other study ID #: JHBahk_bronchial blocker
• Status: Completed
• Phase: N/A
• First received: May 31, 2011
• Last updated: June 20, 2012
• Start date: June 2011
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

One-lung ventilation can be provided by an endobronchial blocker. The Uniblocker® (Fuji Systems Corporation, Tokyo, Japan) was relatively recently introduced into clinical practice. We will try to devise a blind method to locate the Uniblocker® without the aid of fiberoptic bronchoscopy.

Description:

The use of a fiberoptic bronchoscopy (FOB) appears to be fundamental to adjusting position of the bronchial blocker in the targeted mainstem bronchus. However, there can be occasions when a FOB is unavailable or inapplicable. Therefore, we will try to devise a blind method to locate the blocker without the aid of FOB in patients undergoing thoracic surgery.

After intubation of endotracheal tube (ETT), the Uniblocker® is inserted into the ETT and is advanced until the blocker balloon comes out of the ETT tip. At this time, the blocker balloon is inflated with air and the peak inspiratory pressure (PIP) will abruptly increase. And then, the blocker is rotated to the thoracotomy side and advanced to the carina step by step at 0.5 cm intervals. When the PIP drops abruptly, the blocker cuff is deflated completely and advanced to 3 cm further. The blocker cuff is inflated again. Using a FOB, the position of the blocker is recorded and we will evaluate the success rate of proper blocker position.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients undergoing thoracic surgery who need one lung ventilation

Exclusion Criteria:

• patients who have a lesion in trachea or mainstem bronchi

• severe tracheal deviation

• patients who do not agree to informed consent

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endobronchial Blocker
• Fiberoptic Bronchoscopy
• One Lung Ventilation
• Thoracic Surgery

Intervention

Procedure:
• endobronchial blocker
After intubation of endotracheal tube, the Uniblocker® was inserted into the endotracheal tube and advanced step by step with inflation of the blocker balloon until the peak inspiratory pressure dropped abruptly.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of,