Nonintubated Versus Intubated Anesthesia in Video-assisted Thoracic Surgery
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|ClinicalTrials.gov Identifier: NCT04253795|
Recruitment Status : Suspended (not recruiting, awaiting for changes in IRB)
First Posted : February 5, 2020
Last Update Posted : April 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Intubation||Other: Laryngeal mask Other: double lumen tube||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Comparative Study of Nonintubated Anesthesia With Laryngeal Mask Versus Intubated Anesthesia With Double Lumen Tube in Video-assisted Thoracic Surgery|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||February 2021|
Active Comparator: Laryngeal mask group (Group 1)
Laryngeal mask will be placed in the airway by the anesthesiologist. Lung isolation will be achieved with an artificial pneumothorax induced during opening the pleura, which resulted to the collapse of the nondependent lung with the patient's spontaneous breathing
Other: Laryngeal mask
After the laryngeal mask will be inserted lung isolation will be achieved with an artificial pneumothorax induced during opening the pleura, which resulted to the collapse of the nondependent lung with the patient's spontaneous breathing.
Active Comparator: Double lumen tube Group (Group 2)
After the correct position of double lumen tube will be determined, one lung ventilation will be started. Lung isolation will be achieved by deflation of the nondependent lung.
Other: double lumen tube
After the one lung ventilation will be started, lung isolation will be achieved by deflation of the nondependent lung.
- difference in PaO2/FiO2 ratio at the end of the surgery [ Time Frame: 1 hour ]PaO2/FiO2 ratio will be calculated for both groups at the end of the surgery
- Anesthesia time [ Time Frame: 20 minutes ]Anesthesia time will be defined in minute as the time from starting electronically monitored in the operating room until the time the double lumen tube or laryngeal mask was correctly placed
- Operating room time [ Time Frame: 1 hour ]Operating room time will be defined in minute as the time from arrival to operating room until the patient will be transferred to the post anesthetic care unit.
- Post anesthetic care unit (PACU) time [ Time Frame: 30 minutes ]PACU time will be defined in minute as the time from arrival to the PACU until the patient was discharged to the ward.
- Surgeon satisfaction [ Time Frame: 10 minutes ]Surgeon will be asked to rate his satisfaction with the surgical conditions using a 4-point Likert scale (ie, "4: excellent", "3: good", "2: satisfactory", "1: unsatisfactory").
- Patient satisfaction [ Time Frame: 10 minutes ]Patient will be asked to rate his satisfaction using a 4-point Likert scale (ie, "4: excellent", "3: good", "2: satisfactory", "1: unsatisfactory").
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253795
|Antalya Training and Reseach Hospital Department of Anesthesiology and Reanimation|
|Principal Investigator:||Ali Sait Kavakli, M.D.||Antalya Training and Research Hospital|
|Study Director:||Tayfun Sugur, M.D.||Antalya Training and Research Hospital|