A Comparison the Intubation of a Left Sided Double Lumen Tube and Uniblocker
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2017
CompletedStudy Start
First participant enrolled
January 6, 2018
CompletedFirst Posted
Study publicly available on registry
January 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2018
CompletedJanuary 8, 2019
December 1, 2017
4 months
December 16, 2017
January 5, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
The incidence of the optimal position on the first attempt
1 year
The incidence of the injuries of bronchi and carina.
1 year
Secondary Outcomes (4)
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 Uniblocker displacement
1 year
The incidence of sore throat and hoarseness postoperative
1 year
Study Arms (2)
Uniblocker
EXPERIMENTALThe 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
EXPERIMENTALthe double-lumen tube (DLT) is the most commonly used device for OLV
Interventions
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.
the double-lumen tube (DLT) is the most commonly used device for OLV
Eligibility Criteria
You may qualify if:
- Adult patients undergoing left side thoracic surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The first hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000, China
Related Publications (1)
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.
PMID: 32256757DERIVED
Study Officials
- STUDY DIRECTOR
Ximing Qi
The First Hospital of Qinhuangdao
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2017
First Posted
January 8, 2018
Study Start
January 6, 2018
Primary Completion
May 12, 2018
Study Completion
June 25, 2018
Last Updated
January 8, 2019
Record last verified: 2017-12