the Diameter of Double-lumen Tube Measured by Different Methods
The Accuracy of the Diameter of Double-lumen Tube Measured by Different Methods as a Guide to the Size Selection of Double-lumen Tube
1 other identifier
interventional
60
1 country
1
Brief Summary
The comparison of the diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff was collapse or inflated as a guide for the selection of the size of double-lumen tube.
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 Feb 2023
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2023
CompletedStudy Start
First participant enrolled
February 15, 2023
CompletedFirst Posted
Study publicly available on registry
February 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2023
CompletedMay 1, 2024
February 1, 2023
6 months
February 9, 2023
April 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of complications
Incidence of postoperative hoarseness and throat pain in patients
12 weeks
Study Arms (2)
The cuff of endotracheal and endobronchial is collapsed
EXPERIMENTALThe diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff is collapsed
The cuff of endotracheal and endobronchial is inflated
EXPERIMENTALThe diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff is inflated
Interventions
The diameter of double-lumen tube at the cuff of endotracheal and endobronchial when the cuff is collapsed as the diameter of double-lumen tube and select a double-lumen tube that matches the patient's trachea and bronchial innerdiameter based on this diameter
The diameter of double-lumen tube at the cuff of endotracheal and endobronchial when the cuff is inflated as the diameter of double-lumen tube and select a double-lumen tube that matches the patient's trachea and bronchial innerdiameter based on this diameter
Eligibility Criteria
You may qualify if:
- BMI less than 35 kg/m2 ASA classifications of I-III, Modified Mallampati classification 1 or 2 Under general anesthesia
You may not qualify if:
- Age younger than 18 yr or older than 70 yr
- ASA class IV or V
- Abnormalities of the heart, brain, liver, lung, kidney and coagulation function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The first hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000, China
Related Publications (1)
Cui G, Zhao L, Chi C, Liang S, Liu Z. The feasibility and accuracy of the method for selecting the optimal size of double-lumen tube in thoracic surgery: a prospective, randomized controlled trial. Sci Rep. 2024 Jul 30;14(1):17539. doi: 10.1038/s41598-024-68349-z.
PMID: 39080380DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2023
First Posted
February 22, 2023
Study Start
February 15, 2023
Primary Completion
July 30, 2023
Study Completion
August 3, 2023
Last Updated
May 1, 2024
Record last verified: 2023-02