NCT03545737

Brief Summary

One-lung ventilation (OLV) is required for the most of thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) is the commonly used device for OLV. The objective of this study was to compare the accuracy of the distances between vocal cords to carina of trachea and formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 15, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2018

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2018

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

May 15, 2018

Last Update Submit

February 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The incidence of the injuries of bronchi and carina

    The degree of bronchi and carina injuries: 1 clear; 2 a few petechiae; 3coalesced petechiae, hemorrhage, or ecchymosis; 4 erosion

    1-3days

Secondary Outcomes (2)

  • The incidence of dislodgement

    1 day

  • The intubation time

    1-5min

Study Arms (2)

Measurement

The distances between the midpoint of the thyroid cartilage to suprasternal notch base on body surface measurement add the distance between suprasternal notch to carina of trachea according to chest CT.

Other: Measurement

Formula

The formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube. The depth of intubation = 0.1977\* height-4.2423

Other: Formula

Interventions

The distances between the midpoint of the thyroid cartilage to suprasternal notch base on body surface measurement add the distance between suprasternal notch to carina of trachea according to chest CT

Measurement
FormulaOTHER

The formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube

Formula

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1. Age\<18 or \>70 years 2. ASA\>III; BMI\>35kg/m2 3. Without suspected tuberculosis or systemic infection 4. Without severe cardiopulmonary disease, preoperative hoarseness and anticipated difficult airway

You may qualify if:

  • Adult patients undergoing elective left side thoracic surgery
  • Requiring a Uniblocker or DLT for one-lung ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

中国

Qinhuangdao, Hebei, 066000, China

Location

MeSH Terms

Interventions

Weights and MeasuresFood, Formulated

Intervention Hierarchy (Ancestors)

Investigative TechniquesFoods, SpecializedFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2018

First Posted

June 4, 2018

Study Start

June 15, 2018

Primary Completion

November 21, 2018

Study Completion

December 13, 2018

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations