Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299735
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-02-06
Brief Title:
Comparison of Airway Management With Bronchial Blocker and Double-Lumen Tube in Single-Lung Ventilation
Sponsor:
Ankara City Hospital Bilkent
Organization:
Ankara City Hospital Bilkent
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgkg lidocaine 1 µgkg fentanyl 1 mgkg propofol and 07 mgkg rocuronium After 3 minutes of anesthesia induction a double-lumen tubeendotracheal 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 5050 oxygenair with 1-2 sevoflurane will be adjusted to maintain BIS between 40-60 During mechanical ventilation in both groups tidal volume of 6-8 mlkg respiratory rate of 10-12min and PEEP of 4-5 cmH2O will be set for double-lung ventilation and for single-lung ventilation tidal volume of 4-6 mlkg respiratory rate of 12-14min and PEEP of 4-5 cmH2O will be adjusted to maintain PIP25cmH2O SpO290 and PaCO240 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
Anesthesia induction will be performed with 1 mgkg lidocaine 1 µgkg fentanyl 1 mgkg propofol and 07 mgkg rocuronium After 3 minutes of anesthesia induction a double-lumen tubeendotracheal 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 5050 oxygenair with 1-2 sevoflurane will be adjusted to maintain BIS between 40-60 During mechanical ventilation in both groups tidal volume of 6-8 mlkg respiratory rate of 10-12min and PEEP of 4-5 cmH2O will be set for double-lung ventilation and for single-lung ventilation tidal volume of 4-6 mlkg respiratory rate of 12-14min and PEEP of 4-5 cmH2O will be adjusted to maintain PIP25cmH2O SpO290 and PaCO240 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None