Clinical trial NCT06299735: Comparison of Airway Management With Bronchial Blocker and Double-Lumen Tube in Single-Lung Ventilation
Official title: Comparison of Postoperative Pulmonary Complications in Patients Undergoing Minimal Invasive Cardiac Surgeries With the Use of Bronchial Blocker and Double-Lumen Tube in Airway Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Valvular Disease
Coronary Arteriosclerosis
One-lung Ventilation
Keywords: postoperative pulmonary complications
minimally invasive cardiac surgery
one lung ventilation
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Comparison of Postoperative Pulmonary Complications in Patient Groups Undergoing Single-Lung Ventilation with Double-Lumen Tube and Bronchial Blocker
timeFrame: Postoperative 7 days
Secondary outcomes:
measure: Duration of insertion of the double-lumen tube / bronchial blocker
timeFrame: 30 minutes
measure: Incidence of postoperative sore throat
timeFrame: Postoperative 7 days
measure: Incidence of postoperative hoarseness
timeFrame: Postoperative 7 days
measure: Impact of the success of lung collapse
timeFrame: Until the end of the operation (maximum 12 hours )
measure: Satisfactory lung collapse time
timeFrame: Until the end of the operation (maximum 12 hours )
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara bilkent city hospital
state: Çankaya
Study officials:
affiliation: ankara bilkent city hospital, anesthesiology and reanimation clinic
name: Nevriye Salman
role: PRINCIPAL_INVESTIGATOR
References:
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