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

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

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.

Study Overview

• Status: Completed
• Conditions: Therapeutic Procedural Complication
• Intervention / Treatment: Device: Uniblocker; Device: Left-sided Double-lumen Tube

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Qinhuangdao, Hebei, China, 066000
      • The First Hospital of Qinhuangdao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
Experimental: Left-sided Double-lumen Tube; the double-lumen tube (DLT) is the most commonly used device for OLV	Device: Left-sided Double-lumen Tube; the double-lumen tube (DLT) is the most commonly used device for OLV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 lung adequacy collapse	1 year
The incidence of sore throat and hoarseness postoperative	1 year

Collaborators and Investigators

• Sponsor: The First Hospital of Qinhuangdao

Publications and helpful links

General Publications

• Liu Z, Zhao L, Zhu Y, Bao L, Jia QQ, Yang XC, Liang SJ. The efficacy and adverse effects of the Uniblocker and left-side double-lumen tube for one-lung ventilation under the guidance of chest CT. Exp Ther Med. 2020 Apr;19(4):2751-2756. doi: 10.3892/etm.2020.8492. Epub 2020 Feb 5.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2018
• Primary Completion (Actual): May 12, 2018
• Study Completion (Actual): June 25, 2018

Study Registration Dates

• First Submitted: December 16, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 5, 2019
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 966168

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No