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The goal of this study is to evaluate the performance of the new video laryngeal masks for securing airway in patients undergoing general anaesthesia. Main goal is to evaluate the first insertion attempt success rate, time to adequate ventilation, sealing pressures and adverse events.
First, informed consent for study participation will be obtained from the patient. The consent will be collected during the preoperative evaluation by the anesthesiologist responsible for providing anesthesia care during the surgical procedure, in the preoperative holding area.After obtaining informed consent, a routine preoperative assessment will be conducted by the anesthesiologist, including standard preparation procedures (e.g., establishing peripheral venous access, evaluation of airway management risk, etc.). Randomization will be performed using a computerized online tool (studyrandomizer.com).The patient will then be transferred to the operating room, where standard monitoring will be initiated in accordance with the principles of safe anesthesia care.Induction of anesthesia will follow, during which propofol and sufentanil will be administered in doses determined by the attending anesthesiologist. A muscle relaxant will not be used to facilitate insertion of the laryngeal mask airway (LMA). Once an adequate depth of anesthesia is achieved-defined by an entropy value of SE < 60-airway management will proceed according to the patient's assigned group (Group A - SaCoVLM; Group B - Supreme; Group C - Ambu).In both groups, the back of the LMA will be lubricated with a water-based gel. Group A will receive airway management using the SaCoVLMâ„¢ video laryngeal mask. Group B will receive airway management using the Supremeâ„¢ laryngeal mask and Group C will recieve airway management using the Ambu Aura Gain.The following data will be recorded: successful first attempt with adequate ventilation, time to initiation of ventilation, number of attempts required, SpOâ‚‚ at the time of ventilation onset, and EtCOâ‚‚ after initiation. Additionally, the fraction of oxygen in the exhaled gas mixture will be measured before the first insertion attempt and after achieving adequate ventilation. A gastric tube will be inserted via the drainage port in both groups.Surgery will then proceed. During the procedure, oropharyngeal leak pressure will be measured at the 10th and 20th minute following LMA insertion. Ventilation will continue using the inserted LMA throughout the procedure. At the end of surgery, anesthesia will be discontinued, and the LMA will be removed. Upon removal, the presence of blood-tinged secretions on the LMA will be noted.One hour after LMA removal, the patient will be assessed for oropharyngeal discomfort (e.g., sore throat, pain, cough irritation, or blood-streaked sputum). The need for oxygen therapy will also be recorded at 10 minutes and 1 hour following LMA removal. After this, the patient's participation in the study will conclude.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video Laryngeal Mask | Experimental | This arm will have airway secured with SaCo video laryngeal mask. |
|
| Laryngeal Mask Supreme | Active Comparator | This group will have airway secured with traditional Supreme laryngeal mask. |
|
| Laryngeal Mask Ambu | Active Comparator | Laryngeal Mask Ambu Aura Gain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video Laryngeal Mask SaCo VLM | Device | Video laryngeal mask third generation SaCoVLM will be used for airway management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sealing pressure | The maximum sealing pressure that can be reach after insertion and optimal alignment of the laryngeal mask. The APL ventilator will be set to 70 mbar and after there will be plateau on the pressure curve the sealing pressure will be measured. | After achieving adequate ventilation, and at 10 and 20 minutes thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to adequate ventilation | Time from start of the insertion attempt until the adequate ventilation is reached. Adequate ventilation is considered if there are three or more plateau readings in EtCO2 curve. | From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| First insertion attempt success rate | First insertion attempt success rate. Successful attempt is considered if adequate ventilation is reached immediately after insertion without the need for realignment. | From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours. |
Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michal Kalina, MUDr. | Contact | +420773628756 | michalkalina41@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Michal Kalina | Masaryk Hospital Ústà nad Labem Czech Republic | Principal Investigator |
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Data will be store in the depository of University of Jan Evangelista Purkynje in Ústà nad Labem.
The data will be shared in the university repository for five years after completion of the study.
Data will be public in the University depositroy.
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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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| Laryngeal Mask Supreme | Device | Standard laryngeal mask Supreme will be used for airway management. |
|
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| Laryngeal Mask Ambu Aura Gain | Device | Laryngeal Mask Ambu Aura Gain will be used in this group for airway management. |
|
| D008919 |
| Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |