A Comparison the Intubation of a Left Sided Double Lumen Tube and Uniblocker

Not Applicable

Completed

• Conditions: Therapeutic Procedural Complication
• Interventions: Device: Uniblocker; Device: Left-sided Double-lumen Tube

• Registration Number: NCT03392922
• Lead Sponsor: The First Hospital of Qinhuangdao

Brief Summary

One-lung ventilation (OLV) is required for the most thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) and Uniblocker are the commonly used device for OLV.The objective of our study was to comparison the safety and effectiveness of the intubation of the Left-sided Double-lumen Tube and the Uniblocker under the guidence of chest computed tomography (CT) image.

Detailed Description

One-lung ventilation (OLV) is required for the most thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) and Bronchial blockers (BBs) are the commonly used device for OLV.The objective of this study is to comparison the safety and effectiveness of the intubation of the Left-sided Double-lumen Tube and the Uniblocker under the guidence of chest computed tomography (CT) image(the operator count the number of CT slices (slice thickness is 5mm) from vocal cord slice to carina slice to calculate the distance between vocal cord and carina) then measure a distance on the DLT or Uniblocker from the upper edge of the cuff to the mouth side and made a marker on the DLT or Uniblocker.During the intubation the operator insert the DLT or Uniblocker into the trachea via video laryngoscope, after passing the glottis the DLT or Uniblocker are advanced toward the left main-stem bronchus, once the anesthesiologist see the marker on the DLT or the Uniblocker just above the vocal cord stop the insertion.

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-16
• Study First Submitted QC: 2018-01-02
• Study Start: 2018-01-06
• Study First Posted: 2018-01-08
• Primary Completion: 2018-05-12
• Study Completion: 2018-06-25
• Last Update Submitted: 2019-01-05
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adult patients undergoing left side thoracic surgery

Exclusion Criteria

• 1.Age>70 or <18 years 2.ASA classifications >III 3.BMI >35kg/m2 4.Modified Mallampati classification ≥III 5.Thoracic surgery within the last one month 6.Severe cardiopulmonary disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Uniblocker	Uniblocker	The BBs have more advantages than DLT: easier insertion especially in patients with difficult airway18 and no need to exchange the tube when mechanical ventilation is required after surgery
Left-sided Double-lumen Tube	Left-sided Double-lumen Tube	the double-lumen tube (DLT) is the most commonly used device for OLV

Primary Outcome Measures

Name	Time	Method
The incidence of the optimal position on the first attempt	1 year
The incidence of the injuries of bronchi and carina.	1 year

Secondary Outcome Measures

Name	Time	Method
The incidence of lung adequacy collapse	1 year
The incidence of Uniblocker displacement	1 year
The time for the intubation of Uniblocker or Left-sided Double-lumen Tube	1 year
The incidence of sore throat and hoarseness postoperative	1 year

Trial Locations

Locations (1)

The first hospital of Qinhuangdao; 🇨🇳 Qinhuangdao, Hebei, China