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

Not Applicable

Recruiting

• Conditions: Heart Valvular Disease; Coronary Arteriosclerosis; One-lung Ventilation
• Interventions: Procedure: Minimally Invasive Cardiac Surgery (airway management with endobronchial blocker); Procedure: Minimally Invasive Cardiac Surgery (airway management with double-lumen tube)

• Registration Number: NCT06299735
• Lead Sponsor: Ankara City Hospital Bilkent

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-02-01
• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-08-31
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient group using a endobronchial blocker for single-lung ventilation	Minimally Invasive Cardiac Surgery (airway management with endobronchial blocker)	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).
Patient group using a double-lumen tube for single-lung ventilation	Minimally Invasive Cardiac Surgery (airway management with double-lumen tube)	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).

Primary Outcome Measures

Name	Time	Method
Comparison of Postoperative Pulmonary Complications in Patient Groups Undergoing Single-Lung Ventilation with Double-Lumen Tube and Bronchial Blocker	Postoperative 7 days	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.

Secondary Outcome Measures

Name	Time	Method
Impact of the success of lung collapse	Until the end of the operation (maximum 12 hours )	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.
Satisfactory lung collapse time	Until the end of the operation (maximum 12 hours )	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)
Duration of insertion of the double-lumen tube / bronchial blocker	30 minutes	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.
Incidence of postoperative hoarseness	Postoperative 7 days	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.
Incidence of postoperative sore throat	Postoperative 7 days	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.

Trial Locations

Locations (1)

Ankara bilkent city hospital; 🇹🇷 Ankara, Çankaya, Turkey