Video Laryngeal Mask SaCo VLM
DeviceVideo laryngeal mask third generation SaCoVLM will be used for airway management.
Other names: VLMA, Video laryngeal mask
NCT Number: NCT07361042
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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 SaCoVLM™ video laryngeal mask. Group B will receive airway management using the Supreme™ 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, SpO₂ at the time of ventilation onset, and EtCO₂ 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Video laryngeal mask third generation SaCoVLM will be used for airway management.
Other names: VLMA, Video laryngeal mask
Standard laryngeal mask Supreme will be used for airway management.
Other names: Supreme, laryngeal mask
Laryngeal Mask Ambu Aura Gain will be used in this group for airway management.
Time frame: After achieving adequate ventilation, and at 10 and 20 minutes thereafter.
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.
Time frame: From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours.
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.
Time frame: From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours.
First insertion attempt success rate. Successful attempt is considered if adequate ventilation is reached immediately after insertion without the need for realignment.
Contact information is provided by the study sponsor or research team.
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Other
Comparison of Video and Classic Laryngeal Mask Airways: A Prospective Randomized Trial
Acronym: VLMA vs LMA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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