AzTrials
AzTrials

Heart Valvular DiseaseNCT06299735

Comparison of Airway Management With Bronchial Blocker and Double-Lumen Tube in Single-Lung Ventilation

A study testing Minimally Invasive Cardiac Surgery (airway management with double-lumen tube) and Minimally Invasive Cardiac Surgery (airway management with endobronchial blocker) in people with Heart Valvular Disease and Coronary Arteriosclerosis, run by Ankara City Hospital Bilkent 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
Search all trials

Trial summary

In this study, the primary aim is to compare the impact of using a double-lumen tube and bronchial blocker for single-lung ventilation in patients undergoing minimal invasive cardiac surgeries on postoperative pulmonary functions. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Minimally Invasive Cardiac Surgery (airway management with double-lumen tube) and Minimally Invasive Cardiac Surgery (airway management with endobronchial blocker)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteTurkey (Türkiye)
Study dates
17 Apr 2024to 1 May 2025
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients planned for on-pump minimal invasive cardiac surgical procedures requiring single-lung ventilation
  • Female and male patients aged 18 and above
  • Patients with ASA scores of 1-2-3
  • Patients with signed informed consent to participate in the study
  • Patients with a Body Mass Index (BMI) less than 40

Who cannot join

  • Emergency surgeries
  • Patients with ASA scores greater than 3
  • Advanced-stage organ (heart, kidney, liver, lung) failure
  • Advanced lung diseases (COPD, FEV1<50%, restrictive lung diseases, history of chest surgery, Pulmonary Hypertension, PAB>30mmHg)
  • Patients with anticipated difficult intubation
  • Pregnant individuals
  • Patients with a BMI greater than 40
  • Patients lacking the ability to read, understand, sign the informed consent form, and those who do not wish to participate in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara bilkent city hospital

    Ankara, Çankaya, 06530

Other trials in Turkey (Türkiye)

About this study

In this study, the primary aim is to compare the impact of using a double-lumen tube and bronchial blocker for single-lung ventilation in patients undergoing minimal invasive cardiac surgeries on postoperative pulmonary functions. Secondary objectives include the comparison of application duration, success in lung collapse, and the number of repositioning attempts for both techniques.

Read the detailed description

This study is a single-center, prospective, randomized clinical trial. After obtaining ethical approval, 66 patients meeting the inclusion criteria and providing consent, who will undergo minimal invasive cardiac surgery at Ankara City Hospital Heart and Vascular Hospital Operating Room, will be included in the study. Patients will be randomized into two groups using a sealed envelope method (Group DLT: Group undergoing Single-Lung Ventilation with a Double-Lumen Tube, and Group BB: Group undergoing Single-Lung Ventilation with a bronchial blocker within a single-lumen Endotracheal Tube). Both groups will receive standard anesthesia induction and maintenance. Patients brought to the operating room without premedication will start invasive blood pressure monitoring with awake intra-arterial cannulation in addition to standard ASA monitoring.

Anesthesia induction will be performed with 1 mg/kg lidocaine, 1 µg/kg fentanyl, 1 mg/kg propofol, and 0.7 mg/kg rocuronium. After 3 minutes of anesthesia induction, a double-lumen tube/endotracheal tube-bronchial blocker of the appropriate size based on patients' height and gender will be placed. Tube placement will be confirmed with the assistance of a flexible bronchoscope in both groups. During anesthesia maintenance, the gas mixture of 50%/50% oxygen/air with 1-2% sevoflurane will be adjusted to maintain BIS between 40-60. During mechanical ventilation, in both groups, tidal volume of 6-8 ml/kg, respiratory rate of 10-12/min, and PEEP of 4-5 cmH2O will be set for double-lung ventilation, and for single-lung ventilation, tidal volume of 4-6 ml/kg, respiratory rate of 12-14/min, and PEEP of 4-5 cmH2O will be adjusted to maintain PIP<25cmH2O, SpO2>90, and PaCO2<40 mmHg (based on ideal body weight).

Apart from the two compared airway management techniques, both groups will receive standard anesthetic care, multimodal analgesia, and cardiopulmonary bypass method. Determining the impact of these methods on pulmonary functions is crucial to avoid adding potential pulmonary complications related to the inflammatory damage caused by the cardiopulmonary bypass pump to the airway management used for single-lung ventilation. Additionally, comparing the rates of technical complications and placement times for these techniques can guide anesthesia management. Both techniques are routinely used in our clinic for the minimal invasive cardiac surgery procedure based on the preference of anesthesia providers.

Being tested
Minimally Invasive Cardiac Surgery (airway management with double-lumen tube), Minimally Invasive Cardiac Surgery (airway management with endobronchial blocker)
Keywords
postoperative pulmonary complications, minimally invasive cardiac surgery, one lung ventilation
Medical subject headings
Heart Valve Diseases, Coronary Artery Disease

What participants receive

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

  • Minimally Invasive Cardiac Surgery (airway management with double-lumen tube)Procedure or surgery

    Anesthesia induction will involve 1 mg/kg lidocaine, 1 µg/kg fentanyl, 1 mg/kg propofol, and 0.7 mg/kg rocuronium. Following anesthesia induction, a double-lumen tube will be inserted.Subsequently, patients will be connected to a mechanical ventilator. Tube placement will be confirmed using fiberoptic bronchoscopy.

  • Minimally Invasive Cardiac Surgery (airway management with endobronchial blocker)Procedure or surgery

    Anesthesia induction will involve 1 mg/kg lidocaine, 1 µg/kg fentanyl, 1 mg/kg propofol, and 0.7 mg/kg rocuronium. Following anesthesia induction, endotracheal tube-bronchial blocker will be inserted.Subsequently, patients will be connected to a mechanical ventilator. Tube placement will be confirmed using fiberoptic bronchoscopy.

Study groups in NCT06299735
Study groupRoleWhat they receive
Patient group using a double-lumen tube for single-lung ventilationActive comparatorGroup DLT: For the assessment of postoperative pulmonary complications, arterial blood gas analysis, chest X-ray, respiratory sounds, and the patient's oxygen requirement will be monitored every 6 hours for 24 hours. The parameters to be examined preoperatively are: smoking history, ARISCAT score (Age, Preoperative SpO₂, Respiratory infection in the last month, Preoperative anemia (Hgb ≤10 g/dL), Surgical incision, Duration of surgery, Emergency procedure).
Receives: Procedure: Minimally Invasive Cardiac Surgery (airway management with double-lumen tube)
Patient group using a endobronchial blocker for single-lung ventilationActive comparatorGroup BB: For the assessment of postoperative pulmonary complications, arterial blood gas analysis, chest X-ray, respiratory sounds, and the patient's oxygen requirement will be monitored every 6 hours for 24 hours. The parameters to be examined preoperatively are: smoking history, ARISCAT score (Age, Preoperative SpO₂, Respiratory infection in the last month, Preoperative anemia (Hgb ≤10 g/dL), Surgical incision, Duration of surgery, Emergency procedure).
Receives: Procedure: Minimally Invasive Cardiac Surgery (airway management with endobronchial blocker)

What is being measured

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

  1. Comparison of Postoperative Pulmonary Complications in Patient Groups Undergoing Single-Lung Ventilation with Double-Lumen Tube and Bronchial Blocker

    Until discharge;

    • Patients will be regularly visited during the postoperative period.
    • Arterial blood gas analysis will be conducted at 6-hour intervals within the first 24 hours, and if necessary thereafter.
    • Respiratory sounds will be auscultated daily.
    • Chest X-rays will be taken every day.

    The presence of pneumothorax, atelectasis, hemothorax, pneumonia, or ARDS in patients will be observed and recorded.

    Measured: Postoperative 7 days

Secondary outcomes (5)
  1. Duration of insertion of the double-lumen tube / bronchial blocker

    In Double Lumen Tube group : The time elapsed from the beginning of laryngoscopy following the induction of general anesthesia to the placement of the double-lumen tube and its confirmation with fiberoptic bronchoscopy.

    In Bronchial Blocker group : The time elapsed from the beginning of laryngoscopy following the induction of general anesthesia to the completion of endotracheal tube placement, and subsequently, the placement of the bronchial blocker under fiberoptic bronchoscopy guidance will be recorded.

    Measured: 30 minutes

  2. Incidence of postoperative sore throat

    Patients will be visited daily during the postoperative period, and they will be asked if they have sore throat . The intensity of throat pain will be assessed using a visual analog scale. Patients will be asked to assign a number from 0 to 10 to describe the severity of their pain (0: no pain, 10: severe pain ) and it will be recorded.

    Measured: Postoperative 7 days

  3. Incidence of postoperative hoarseness

    Patients will be visited daily during the postoperative period, and they will be asked if they have hoarseness and it will be recorded as either yes or no.

    Measured: Postoperative 7 days

  4. Impact of the success of lung collapse

    End of the surgery, the surgeon will be asked about the level of lung collapse, and they will be requested to assign a number indicating the level of maximum collapse on a verbal rating scale from 0 to 10. (0 :no lung collapse, 10: complete collapse) And it will be recorded.

    Measured: Until the end of the operation (maximum 12 hours )

  5. Satisfactory lung collapse time

    After one lung ventilation begins, the surgeon will be asked about the level of lung collapse,and they will be instructed to notify when satisfactory lung collapse (when the collapse score of 8) is achieved.The time elapsed from the initiation of single-lung ventilation until satisfactory collapse is achieved will be recorded. ( minutes)

    Measured: Until the end of the operation (maximum 12 hours )

Timeline

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

  1. First posted8 Mar 2024
  2. Study start17 Apr 2024
  3. Primary completion31 Dec 2024
  4. Study completion1 May 2025

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
Prevention
Allocation
Randomised
Intervention model
Sequential
Model description
The anesthesia method applied for both patient groups is the same. However, the airway maintenance device used will vary between two different patient groups. Group BB: A bronchial blocker will be used for this patient group, Group DLT: A double-lumen tube will be used for this patient group. The parameters to be recorded for both patient groups include: preoperative smoking history, ARISCAT score, systolic arterial pressure, diastolic arterial pressure, saturation, pulse, and the duration of airway device insertion following anesthesia induction and intubation. For the assessment of postoperative pulmonary complications in both patient groups, arterial blood gas analysis, chest X-ray, respiratory sounds, and the patient's oxygen requirement will be monitored every 6 hours for 24 hours.
Masking
Single blind
Who is masked
Participant
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06299735
Sponsor's protocol ID
AsenaIremYildiz1
Status last verified
Jan 2024
First submitted
6 Feb 2024
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ganapathy S. Anaesthesia for minimally invasive cardiac surgery. Best Pract Res Clin Anaesthesiol. 2002 Mar;16(1):63-80. doi: 10.1053/bean.2001.0208.

    PubMed 12491544
  • Vernick W, Atluri P. Robotic and minimally invasive cardiac surgery. Anesthesiol Clin. 2013 Jun;31(2):299-320. doi: 10.1016/j.anclin.2012.12.002. Epub 2013 Mar 13.

    PubMed 23711646
  • Patel M, Wilson A, Ong C. Double-lumen tubes and bronchial blockers. BJA Educ. 2023 Nov;23(11):416-424. doi: 10.1016/j.bjae.2023.07.001. Epub 2023 Sep 18. No abstract available.

    PubMed 37876764
  • Knoll H, Ziegeler S, Schreiber JU, Buchinger H, Bialas P, Semyonov K, Graeter T, Mencke T. Airway injuries after one-lung ventilation: a comparison between double-lumen tube and endobronchial blocker: a randomized, prospective, controlled trial. Anesthesiology. 2006 Sep;105(3):471-7. doi: 10.1097/00000542-200609000-00009.

    PubMed 16931978
  • Kottenberg-Assenmacher E, Kamler M, Peters J. Minimally invasive endoscopic port-access intracardiac surgery with one lung ventilation: impact on gas exchange and anaesthesia resources. Anaesthesia. 2007 Mar;62(3):231-8. doi: 10.1111/j.1365-2044.2007.04954.x.

    PubMed 17300299
  • Ender J, Bury AM, Raumanns J, Schlunken S, Kiefer H, Bellinghausen W, Petry A. The use of a bronchial blocker compared with a double-lumen tube for single-lung ventilation during minimally invasive direct coronary artery bypass surgery. J Cardiothorac Vasc Anesth. 2002 Aug;16(4):452-5. doi: 10.1053/jcan.2002.125144.

    PubMed 12154424
  • Ko R, McRae K, Darling G, Waddell TK, McGlade D, Cheung K, Katz J, Slinger P. The use of air in the inspired gas mixture during two-lung ventilation delays lung collapse during one-lung ventilation. Anesth Analg. 2009 Apr;108(4):1092-6. doi: 10.1213/ane.0b013e318195415f.

    PubMed 19299766
  • Zhang Y, Yan W, Fan Z, Kang X, Tan H, Fu H, Li Z, Chen KN, Chen J. Preemptive one lung ventilation enhances lung collapse during thoracoscopic surgery: A randomized controlled trial. Thorac Cancer. 2019 Jun;10(6):1448-1452. doi: 10.1111/1759-7714.13091. Epub 2019 May 21.

    PubMed 31115153

Questions about this trial

What is this clinical trial studying?

A study testing Minimally Invasive Cardiac Surgery (airway management with double-lumen tube) and Minimally Invasive Cardiac Surgery (airway management with endobronchial blocker) in people with Heart Valvular Disease and Coronary Arteriosclerosis, run by Ankara City Hospital Bilkent 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 5 inclusion and 8 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 27 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?

Comparison of Postoperative Pulmonary Complications in Patient Groups Undergoing Single-Lung Ventilation with Double-Lumen Tube and Bronchial Blocker (time frame: Postoperative 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06299735, which also lists 8 linked publications.

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 27 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in