Ankara bilkent city hospital
Ankara, Çankaya, 06530, Turkey (Türkiye)
NCT Number: NCT06299735
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Ankara, Çankaya, 06530, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Postoperative 7 days
Until discharge;
The presence of pneumothorax, atelectasis, hemothorax, pneumonia, or ARDS in patients will be observed and recorded.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Ankara City Hospital Bilkent
Other
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