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

Therapeutic Procedural Complication Clinical Trial

Official title:

A Comparison the Intubation of a Left Sided Double Lumen Tube and the Uniblocker Under the Guidence of Chest Computed Tomography Image

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392922
• Other study ID #: 966168
• Status: Completed
• Phase: N/A
• Start date: January 6, 2018
• Est. completion date: June 25, 2018

Study information

• Verified date: December 2017
• Source: The First Hospital of Qinhuangdao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 25, 2018
• Est. primary completion date: May 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Therapeutic Procedural Complication

Intervention

Device:
• 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
the double-lumen tube (DLT) is the most commonly used device for OLV

Locations

Country	Name	City	State
China	The first hospital of Qinhuangdao	Qinhuangdao	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Qinhuangdao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of the optimal position on the first attempt		1 year
Primary	The incidence of the injuries of bronchi and carina.		1 year
Secondary	The time for the intubation of Uniblocker or Left-sided Double-lumen Tube		1 year
Secondary	The incidence of lung adequacy collapse		1 year
Secondary	The incidence of Uniblocker displacement		1 year
Secondary	The incidence of sore throat and hoarseness postoperative		1 year