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not recruiting, awaiting for changes in IRB
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The purpose of this study is to compare to the patients undergoing nonintubated general anesthesia with laryngeal mask and undergoing intubated general anesthesia with double-lumen endotracheal intubation in Video-assisted thoracic surgery (VATS).
Although general anesthesia with double-lumen intubation is generally mandatory for Video-assisted thoracic surgery procedures intubation with double lumen tube is related to several risks. Nonintubated general anesthesia with laryngeal mask in patients with spontaneous breathing may be an alternative choice for minor VATS procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laryngeal mask group (Group 1) | Active Comparator | 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 |
|
| Double lumen tube Group (Group 2) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laryngeal mask | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| difference in PaO2/FiO2 ratio at the end of the surgery | PaO2/FiO2 ratio will be calculated for both groups at the end of the surgery | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Anesthesia time | 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 | 20 minutes |
| Operating room time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Sait Kavakli, M.D. | Antalya Training and Research Hospital | Principal Investigator |
| Tayfun Sugur, M.D. | Antalya Training and Research Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antalya Training and Reseach Hospital Department of Anesthesiology and Reanimation | Antalya | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D017214 | Laryngeal Masks |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
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| double lumen tube | Other | After the one lung ventilation will be started, lung isolation will be achieved by deflation of the nondependent lung. |
|
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.
| 1 hour |
| Post anesthetic care unit (PACU) time | PACU time will be defined in minute as the time from arrival to the PACU until the patient was discharged to the ward. | 30 minutes |
| Surgeon satisfaction | 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"). | 10 minutes |
| Patient satisfaction | Patient will be asked to rate his satisfaction using a 4-point Likert scale (ie, "4: excellent", "3: good", "2: satisfactory", "1: unsatisfactory"). | 10 minutes |
| D008919 |
| Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |