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One-Lung VentilationNCT06457763

Left Double Lumen Tube Selection

A study testing Ultrasound in people with One-Lung Ventilation and Thoracic Surgery, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to determine the accuracy and practicality of ultrasound in the selection of double lumen tube and whether the complications that may occur intraoperatively and postoperatively can be reduced. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
One-Lung Ventilation, Thoracic Surgery
What is being tested?
Ultrasound
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Aug 2023to 29 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients who will place a left double lumen tube to perform one lung ventilation
  • Between the ages of 18-75
  • ASA 1-2-3 patients

Who cannot join

  • Patients with a previous history of difficult intubation
  • Patients who have previously undergone head and neck surgery or received radiotherapy
  • Patients with a Cormark-Lehane classification of 3-4 by the thoracic anaesthetist performing intubation,
  • Patients with previous cough and sore throat

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Marmara University

    Istanbul, Maltepe, 34854

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Ultrasound and Classical Method for Left Double Lumen Tube Selection in One-Lung Ventilation: A Randomised Controlled Study

The aim of this study was to determine the accuracy and practicality of ultrasound in the selection of double lumen tube and whether the complications that may occur intraoperatively and postoperatively can be reduced.

Patients aged 18-75 years with ASA 1-2-3 who give informed consent for left double lumen tube placement for single lung ventilation will be included in this study. Patients with a history of previous difficult intubation, head and neck surgery and radiotherapy, class 3-4 in the Colmark-Lehane classification by the thoracic anaesthetist who will perform the intubation, and patients with previously known hoarseness and chronic cough will not be included in the study. Patients who accept the study will be randomly assigned to one of the anaesthesia groups including ultrasound group (Group 1) and classical method (Group 2).

Randomisation will be in a 1:1 ratio and will be done by closed envelope method.

Read the detailed description

The aim of this study was to determine the accuracy and practicality of ultrasound in the selection of double lumen tube and whether the complications that may occur intraoperatively and postoperatively can be reduced.

In thoracic surgery, single lung ventilation is one of the most challenging airway and ventilation methods for anaesthetists. Bronchial blockers and double lumen tubes are the tools used to isolate the lung in single lung ventilation and double lumen tubes are used more frequently. Size is important when choosing a double lumen tube. There is no definite rule when choosing the tube size. When selecting the size of the double lumen tube, there is a classical method selected according to the gender and height of the patient. However, due to anatomical differences between individuals; inappropriate tube sizes may be selected and this may lead to consequences such as tracheabronchial injury and insufficient deflation of the lungs.

The use of ultrasound can provide rapid assessment of airway anatomy in the operating theatre, intensive care unit and emergency department. Ultrasound is a suitable tool for the evaluation of the subglottic airway confirmed by computed tomography. The use of ultrasound requires less training and the patient does not need to be fully immobilised and sedated. There is a correlation between the diameter of the external trachea measured by ultrasound just above the sternoclavicular junction and the diameter of the left main bronchus measured by computed tomography scan.

Patients aged 18-75 years with ASA 1-2-3 who give informed consent for left double lumen tube placement for single lung ventilation will be included in this study. Patients with a history of previous difficult intubation, head and neck surgery and radiotherapy, class 3-4 in the Colmark-Lehane classification by the thoracic anaesthetist who will perform the intubation, and patients with previously known hoarseness and chronic cough will not be included in the study. Patients who accept the study will be randomly assigned to one of the anaesthesia groups including ultrasound group (Group 1) and classical method (Group 2).

Randomisation will be in a 1:1 ratio and will be done by closed envelope method. A paper with the name of one of the two groups will be placed in the envelopes beforehand and the envelopes will be closed and mixed. For each patient, a closed envelope will be drawn randomly before the procedure and the procedures will be performed according to the group indicated on the paper.

Intraoperative anaesthesia management Before induction of anaesthesia, the patients in this group will be placed in the supine position with the head in slight extension and the outer diameter of the trachea will be measured with a linear probe 0.5 cm above the sternoclavicular joint by placing the ultrasound transverse and the patient will be intubated by selecting a left double lumen tube suitable for this measurement.

In the classical method group (Group2), 37 fr left double lumen tube was selected for female patients taller than 160 cm and 35 fr left double lumen tube was selected for patients shorter than 160 cm. For male patients, a 41 fr left double lumen tube was selected for patients taller than 170 cm and a 39 fr tube was selected for men shorter than 170 cm.

Anaesthesia induction was performed with propofol (2 mg/kg), remifentanil 1mcg/kg, and rocuronium 0.6 mg/kg under standard monitoring (ECG, non-invasive blood pressure, and finger prick oxygen saturation). In both groups of patients, after direct laryngoscopy and visualisation of the vocal cords, the tip of the left double lumen tube was rotated 90 degrees counterclockwise past the vocal cords and pushed until resistance was felt. The depth of the left double lumen tube was determined as 12+ patient height (cm)/10 cm from the tooth level and then the location of the tube was confirmed with a fibreoptic bronchoscope.

Being tested
Ultrasound
Keywords
Ultrasound, Double lumen tube, Postoperative complication
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasoundOther

    with ultrasound meauser

Study groups in NCT06457763
Study groupRoleWhat they receive
UltrasoundActive comparatorWhile the patients were in the supine position on the operating room table, the external tracheal diameter, measured just above the sternoclavicular junction, was measured by ultrasound. Appropriately sized tube size was selected in accordance with previous studies and cadaver studies.
Receives: Other: Ultrasound
conventionalActive comparatorFor female patients, a 37 fr left double lumen tube was chosen for patients taller than 160 cm, and a 35 fr left double lumen tube was chosen for patients shorter than 160 cm. For male patients, a 41 fr left double lumen tube was selected for patients taller than 170 cm and a 39 fr tube was chosen for men shorter than 170 cm.
Receives: Other: Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative cough and sore throat

    Zero: No sore throat; 1: Mild, sore throat only when swallowing; 2: Moderate, persistent sore throat, aggravated when swallowing; 3: Severe, throat pain affecting the patient's eating, and analgesic drugs were needed

    Measured: postoperative first at 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start1 Aug 2023
  3. Primary completion1 Sep 2023
  4. Study completion29 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06457763
Sponsor's protocol ID
09.2022.755
Status last verified
Feb 2026
First submitted
29 May 2024
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound in people with One-Lung Ventilation and Thoracic Surgery, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative cough and sore throat (time frame: postoperative first at 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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