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).
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.
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.
- Conditions
- One-Lung Ventilation, Thoracic Surgery
- 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 group | Role | What they receive |
|---|---|---|
| Ultrasound | Active comparator | While 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 |
| conventional | Active comparator | For 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.
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.
- First posted13 Jun 2024
- Study start1 Aug 2023
- Primary completion1 Sep 2023
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for One-Lung VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meliha Orhon, Marmara University
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound and Classical Method for Left Double Lumen Tube Selection in One-Lung Ventilation: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06457763
- Acronym / sponsor ID
- 09.2022.755
- Conditions
- One-Lung Ventilation, Thoracic Surgery
- Keywords
- Ultrasound, Double lumen tube, Postoperative complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Active comparator | Other: UltrasoundWhile 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. |
| conventional | Active comparator | Other: UltrasoundFor 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasoundwith ultrasound meauser | Other | Ultrasound, conventional |
Primary outcome
postoperative cough and sore throat
Time frame: postoperative first at 24 hours
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
Related trials for One-Lung Ventilation
Not yet recruiting
Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery
Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs)
Recruiting
BMI-Adjusted PEEP During One-Lung Ventilation in Thoracic Surgery
Pulmonary Resection Surgery, One Lung Ventillation (OLV)
Not yet recruitingObservational study
Comparison of Different Ventilation Modes in Video-Assisted Thoracoscopic Lung Resection
One-lung Ventilation (OLV), Video-assisted Thoracis Surgery (VATS)
Not yet recruiting
Brief Bronchial Suction for Lung Collapse During Uniportal VATS
Lung Collapse, One-lung Ventilation
Not yet recruiting
Video-guided Versus Conventional Right-sided Double-lumen Tube Placement for Thoracoscopic Surgery
Right-sided Double-lumen Tube Positioning, Lung Isolation During Thoracoscopic Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.