NCT07191002

Brief Summary

In most clinical scenarios, left DLT is preferred for one-lung ventilation because of its anatomical ease of placement; these tubes allow separate ventilation of both lungs. If the DLT is not placed in the proper size and depth, it may result in repeated intubation attempts, airway and dental trauma, failed lung isolation, tube dislodgement, and various unwanted events such as hypoxemia. The first and most common method for correct placement of a DLT is the conventional technique, blindly advanced into the left main bronchus, and then confirmed with fiberoptic bronchoscopy (FOB). In this method, the depth at which the tube should be left before performing FOB is left to the clinician's experience. Generally, the DLT is advanced in the trachea until a slight resistance is felt. This may lead to excessive advancement of the DLT into the left main bronchus or premature resistance due to the tube tip touching the carina, causing the clinician to stop before entering the left main bronchus. Therefore, just as selecting the correct size of the DLT is crucial, correctly estimating the appropriate depth is also of great importance. For this reason, different formulas have been proposed in the literature, and new formulas are still being investigated. The patient's gender and height are determinant in selecting the appropriate size of the DLT. However, studies in the literature indicate that the accuracy of these formulas may be limited in Asian populations. Therefore, it is important to evaluate the applicability of these formulas in different populations and, if necessary, develop new formulas. In the Turkish population as well, verifying the accuracy of these formulas for determining the proper size and depth of DLT-and if needed, developing new recommendations and formulas-holds clinical importance. In this study, conducted at Ankara Atatürk Sanatorium Training and Research Hospital, the aim is to evaluate the accuracy of six different formulas available in the literature for predicting DLT depth in patients undergoing thoracic surgery. Additionally, the correlations between DLT depth and demographic parameters as well as external airway measurements (mouth opening, sternomental distance, thyromental distance, distance between the mentum and manubrio-sternal angle, distance between tragus and manubrio-sternal angle, distance between sternal angle and xiphoid process) will be analyzed. Furthermore, challenges during DLT application, malposition rates and types, and complications will be assessed. The primary objective of this study is to evaluate, in patients undergoing thoracic surgery at Ankara Atatürk Sanatorium Training and Research Hospital, how accurate and applicable six different formulas defined in the literature are for predicting the placement depth of the DLT. If the existing formulas are insufficient, the aim is to develop a new formula.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

September 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

September 29, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

September 17, 2025

Last Update Submit

September 29, 2025

Conditions

Keywords

Double-Lumen TubeFiberoptic BronchoscopyAirway MeasurementsOne-Lung VentilationTube Placement DepthThoracic Anesthesia

Outcome Measures

Primary Outcomes (1)

  • consistency between the DLT depths calculated using six different formulas

    The primary outcome of the study is the consistency between the DLT depths calculated using six different formulas defined in the literature and the actual placement depth confirmed by fiberoptic bronchoscopy (FOB).

    during perioperative

Study Arms (1)

intubated with a left DLT

Patients who will undergo surgery under general anesthesia and be intubated with a left DLT

Other: placement depth of the double lumen tube

Interventions

the anesthesiologist will select the appropriate DLT size and placement depth entirely at their discretion, as per routine practice, and confirm both using fiberoptic bronchoscopy (FOB). If malposition occurs, it will be corrected under FOB guidance, and the tube will be secured in the correct position

intubated with a left DLT

Eligibility Criteria

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

The study will begin prospectively after obtaining approval from the ethics committee and will be completed once the target number of patients has been reached. The study population will consist of patients aged 18-80 years who will undergo thoracic surgery at the operating rooms of the Department of Anesthesiology and Reanimation, Ankara Atatürk Sanatorium Training and Research Hospital.

You may qualify if:

  • Patients older than 18 and younger than 80 years
  • Patients who will undergo surgery under general anesthesia and be intubated with a left DLT
  • Patients with an American Society of Anesthesiologists (ASA) score of I-II-III
  • Patients with a body mass index (BMI) between 18-40 kg/m²
  • Patients who provide informed consent

You may not qualify if:

  • Patients requiring right DLT placement
  • Patients with ASA score IV and above
  • Patients intubated with a single-lumen tube
  • Patients in whom lung isolation will be achieved with a method other than DLT
  • Emergency cases
  • Patients younger than 18 or older than 80 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Ataturk Sanatorium Training and Research Hospital, Ankara, 06280

Ankara, Turkey (Türkiye)

RECRUITING

Study Officials

  • ELİF DURMUŞ

    ANKARA ATATURK SANATORİUM TRAİNİNG AND RESEARCH HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinic Associate Professor

Study Record Dates

First Submitted

September 17, 2025

First Posted

September 24, 2025

Study Start

September 29, 2025

Primary Completion

February 15, 2026

Study Completion

March 30, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations