NCT05133401

Brief Summary

In thoracic surgery, one-lung ventilation using a double-lumen tube (DLT) is often performed to protect dependent lung and provide comfortable surgical conditions. However, serious complications and adverse events can be encountered during DLT placement. One of the most important steps to avoid these drawbacks is to choose the appropriate size of DLT. The width of the trachea can be measured by using different imaging methods such as computed tomography (CT) and ultrasonography (US) to predict the appropriate DLT size. CT can also contribute to the proper placement of DLT by giving us the length of the trachea and main bronchi. In this study, we hypothesized that the size of the DLT can be determined more accurately by measuring the trachea diameter by using US and CT before DLT intubation. At the same time, we aimed to determine whether the evaluation of tracheobronchial anatomy with CT would contribute to the placement of DLT at a more appropriate level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

November 4, 2021

Last Update Submit

January 21, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • The measurement of the trachea diameter with ultrasound determines the size of the double-lumen tube to be used.

    After measuring the diameter of the trachea with ultrasound, the doctor will determine the double-lumen tube to be used according to the ultrasound measurement. Another experienced anesthesiologist, unaware of this result, will insert the double-lumen tube that he has determined with the conventional method.

    1 hour

  • The measurement of the trachea diameter by computerized tomography determines the size of the double-lumen tube is used.

    After measuring the diameter of the trachea with computerized tomography, the doctor will determine the double-lumen tube to be used according to the computerized tomography measurement. Another experienced anesthesiologist, unaware of this result, will insert the double-lumen tube that he has determined with the conventional method.

    1 hour

  • The measurement of the tracheal and main bronchi length and main bronchi diameter by computerized tomography in determining the size of the double-lumen tube and proper positioning of the double-lumen tube.

    The correlation of predicted and used DLT size. In addition, the correlation between DLT malposition rate and trachea and main bronchi length and main bronchi diameter measured by imaging methods.

    1 hour

Secondary Outcomes (1)

  • Complications related to double-lumen tube intubation

    1 day

Interventions

Ultrasound measurements will be made with a 5-10 MegaHertz linear probe positioned in the horizontal plane at the midline of the anterior neck. After identifying the vocal cords as paired hyperechoic linear structures, the probe was moved caudally to visualize the cricoid arch. The transverse air column diameter was measured at the lower border of the cricoid cartilage.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 100 patients with a body mass index between18-35 kg/m2 in the ASA I-II-III risk group, aged 18-80, who will undergo elective thoracic surgery, require intubation with a double-lumen tube will be included in the study.

You may qualify if:

  • Patients who will undergo elective thoracotomy or video-assisted thoracic surgery with general anesthesia with DLT intubation
  • BMI 18 - 35 kg/m2
  • Age 18 - 80 years old

You may not qualify if:

  • Mallampati score 3 and 4
  • History of tracheostomy, tracheal deviation, or distortion
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital

Keçiören, Ankara, 06000, Turkey (Türkiye)

Location

Study Officials

  • Ali Alagoz, Assoc Prof

    Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 4, 2021

First Posted

November 24, 2021

Study Start

June 1, 2021

Primary Completion

November 30, 2021

Study Completion

December 30, 2021

Last Updated

January 24, 2022

Record last verified: 2022-01

Locations