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

NCT06299735 | Completed

• 1 other identifier: AsenaIremYildiz1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. Secondary objectives include the comparison of application duration, success in lung collapse, and the number of repositioning attempts for both techniques.

Conditions

Heart Valvular Disease; Coronary Arteriosclerosis; One-lung Ventilation

Keywords

postoperative pulmonary complications; minimally invasive cardiac surgery; one lung ventilation

Outcome Measures

Primary Outcomes (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.

  Postoperative 7 days

Secondary Outcomes (5)

• Duration of insertion of the double-lumen tube / bronchial blocker

  30 minutes

• Incidence of postoperative sore throat

  Postoperative 7 days

• Incidence of postoperative hoarseness

  Postoperative 7 days

• Impact of the success of lung collapse

  Until the end of the operation (maximum 12 hours )

• Satisfactory lung collapse time

  Until the end of the operation (maximum 12 hours )

Study Arms (2)

Patient group using a double-lumen tube for single-lung ventilation

ACTIVE COMPARATOR

Group 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).

Procedure: Minimally Invasive Cardiac Surgery (airway management with double-lumen tube)

Patient group using a endobronchial blocker for single-lung ventilation

ACTIVE COMPARATOR

Group 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).

Procedure: Minimally Invasive Cardiac Surgery (airway management with endobronchial blocker)

Interventions

Minimally Invasive Cardiac Surgery (airway management with endobronchial blocker) PROCEDURE

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.

Patient group using a endobronchial blocker for single-lung ventilation

Minimally Invasive Cardiac Surgery (airway management with double-lumen tube) PROCEDURE

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.

Patient group using a double-lumen tube for single-lung ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara bilkent city hospital

Ankara, Çankaya, 06530, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 12491544 RESULT

• 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.

  PMID: 23711646 RESULT

• 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.

  PMID: 37876764 RESULT

• 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.

  PMID: 16931978 RESULT

• 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.

  PMID: 17300299 RESULT

• 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.

  PMID: 12154424 RESULT

• 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.

  PMID: 19299766 RESULT

• 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.

  PMID: 31115153 RESULT

MeSH Terms

Conditions

Heart Valve Diseases; Coronary Artery Disease

Interventions

Airway Management

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Nevriye Salman

  ankara bilkent city hospital, anesthesiology and reanimation clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: March 8, 2024
• Study Start: April 17, 2024
• Primary Completion: December 31, 2024
• Study Completion: May 1, 2025
• Last Updated: February 27, 2026

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)