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

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.

Study Overview

• Status: Completed
• Conditions: Therapeutic Procedural Complication
• Intervention / Treatment: Device: The cuff of endotracheal and endobronchial is collapsed; Device: The cuff of endotracheal and endobronchial is inflated

Detailed Description

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.

• 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

Description

Inclusion Criteria:

BMI less than 35 kg/m2 ASA classifications of I-III, Modified Mallampati classification 1 or 2 Under general anesthesia

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The cuff of endotracheal and endobronchial is collapsed; The diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff is collapsed	Device: The cuff of endotracheal and endobronchial is collapsed; 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
Experimental: The cuff of endotracheal and endobronchial is inflated; The diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff is inflated	Device: The cuff of endotracheal and endobronchial is inflated; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of complications	Incidence of postoperative hoarseness and throat pain in patients	12 weeks

Collaborators and Investigators

• Sponsor: The First Hospital of Qinhuangdao

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): August 3, 2023

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 18, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022A123

Drug and device information, study documents

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