Adequate Additional Bronchial Cuff Volume to Achieve Blood-tight Seal After Air-tight Seal in Double Lumen Tube

Not Applicable

• Conditions: Preventing Blood Leakage of Bronchial Cuff
• Interventions: Procedure: 37 Fr double lumen tube group; Procedure: 39 Fr double lumen tube group; Procedure: 35 Fr double lumen tube group

• Registration Number: NCT01979640
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to find the adequate additional bronchial cuff volume after achievement of air-tight seal, that can achieve blood-tight seal(preventing leakage of blood through cuff) in double lumen tube

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-11-03
• Study First Submitted QC: 2013-11-03
• Study First Posted: 2013-11-08
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-20
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• patients undergoing thoracic surgery under left lower decubitus position, using left sided double lumen tube
• patient's left main bronchus size adequate for 35Fr, 37 Fr, 39 Fr double lumen tube

Read More

Exclusion Criteria

• dislocation or great movement of double lumen tube depth

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
37 Fr double lumen group	37 Fr double lumen tube group	patients are assigned to 35 Fr, 37 Fr, 39 Fr double lumen tube group according to their left main bronchus diameter measured by preoperative chest CT, to minimize difference between main bronchus diameter and bronchial tip diameter of double lumen tube
39 Fr double lumen group	39 Fr double lumen tube group	patients are assigned to 35 Fr, 37 Fr, 39 Fr double lumen tube group according to their left main bronchus diameter measured by preoperative chest CT, to minimize difference between main bronchus diameter and bronchial tip diameter of double lumen tube
35 Fr double lumen tube group	35 Fr double lumen tube group	patients are assigned to 35 Fr, 37 Fr, 39 Fr double lumen tube group according to their left main bronchus diameter measured by preoperative chest CT, to minimize difference between main bronchus diameter and bronchial tip diameter of double lumen tube

Primary Outcome Measures

Name	Time	Method
leakage of autologus blood through bronchial cuff	10, 20, 30 minutes after dripping of blood around bronchial cuff

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of