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Laryngeal Masks clinical trials

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NCT ID: NCT06237504 Recruiting - Elderly Clinical Trials

The Clinical Efficacy of the Video Laryngeal Mask (SaCoVLM™) in Geriatric Patients: A Comparison With a Conventional Supraglottic Airway Device (Ambu®Auragain™)

Start date: February 2024
Phase: N/A
Study type: Interventional

This study aims to investigate whether the use of a video LMA device (SacoVLM™) will facilitate successful supraglottic airway device (SAD) insertion compared to the use of a conventional 2nd generation SAD (Ambu®Auragain™) in elderly patients. This study is a randomized trail with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.

NCT ID: NCT06168981 Enrolling by invitation - Anxiety Clinical Trials

The Effect of Preoperative Chewing Gum on Anxiety and Sore Throat in Patients With Laryngeal Mask Airway

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

This study was planned to investigate the effect of chewing gum in the preoperative period on patients' sore throat and anxiety levels.

NCT ID: NCT06140667 Recruiting - Clinical trials for Laryngeal Masks Comparison

Laryseal Pro LMA Versus Ambu Aura Gain LMA in Elective Ophthalmological Surgeries

Start date: November 17, 2023
Phase: N/A
Study type: Interventional

Tracheal intubation is considered the gold standard for protecting the airway. As the supraglottic airway devices (SADs) could be inserted without laryngoscopy, so that SADs with different designs and safety issues could be used to manage difficult airways in anesthesia and emergency medicine with continuous patient oxygenation &ventilation, less hemodynamic stress response and less postoperative complications. Many health care providers do not have the requisite knowledge and enough practice to perform safe and quick intubation. For these providers, SADs can be a valid alterative especially in untrained personnel, or when tracheal intubation is impossibe. Both devices are with a cuff modified to improve the seal around the glottis and a drainage tube to provide a bypass channel for regurgitated gastric contents, prevent gastric insufflation, and allow the passage of a gastric tube. These features are designed to improve the safety of the mask and broaden its scope, especially when used with positive pressure ventilation. The AuraGain is Ambu ꞌs 3rd generation disposable laryngeal mask, satisfying 3 fundamental airway management needs by integrating gastric access channel for managing gastric content and intubation capability using standard ET-tubes in an anatomically curved single-use device that facilitates rapid establishment of a safe airway through integrated bite absorption area that could prevent airway occlusion. Other characters include pilot balloon that identifies mask size and provides tactile indication of degree of inflation, navigation marks for guiding flexible scope and is made of phthalate-free material. Its thin and soft cuff is designed to deliver high seal pressure up to 40 cmH2O. It was presented in the clinical market in sizes 3, 4, 5 and 6 (according to the body weight; size 3: 30-50 kg, size 4: 50-70 kg, size 5: 70-100 kg, and size 6: >100 kg) that can accept tracheal tube in sizes ranging from 6.5 up to 7.5 and 8mm inner diameter respectively with maximum suction catheter size of 16 Fr. The LarysealTM Pro is the new generation mask for safe and effective airway management, as it could reduce the risk of aspiration by the integrated suction catheter port to allow effective removal of fluids and gastric contents. So that, it could be a promising airway device as its symmetrical cuff and tube contoured to match the oropharyngeal anatomy for quick and easy first time insertion success. It could be applied in both routine and advanced airway management for patients with a higher risk of a difficult airway, unexpected intubation difficulties, beside to airway control during anesthesia. It was presented in the clinical market in sizes 3, 4 and 5 (according to the body weight; size 3: 30-50Kg, size 4: 50-70 Kg, and size 5:70-100Kg) that can accept larger tracheal tube up to 7.5 and 8mm inner diameter respectively with maximum suction catheter size of 16 Fr. The Laryseal pro could provide a rapid and secure airway management and improve patient safety with gastric access reducing the risk of pulmonary aspiration, in addition to speeding up the ETT tube placement if needed with a unique guide system, beside to integrated fenestrated flap that protects from blockage with minimal increase in flow resistance. All these features of laryseal pro allow quick easy first time insertion success. After approval of the Local Ethical Committee and obtaining an informed written consent from every patient, then patients will be categorized randomly into two equal groups using the computer allocation software to be put into opaque closed-envelopes: GL (n=27): Laryseal TM Pro. GA (n=27): Ambu Aura Gain.

NCT ID: NCT06073977 Recruiting - Children Clinical Trials

Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation

PEDSGAP
Start date: October 9, 2023
Phase:
Study type: Observational [Patient Registry]

This study is designed to observe the occurrence of failure or difficulty during placement of supraglottic airway devices (SGAs) and its associated risk factors in pediatric patients. Despite wide use in pediatric practice, not much is known related to problems during SGA insertion unlike adults. The main information regarding pediatric SGA comes from either small comparative studies or retrospective studies reporting increased risk of failure. Thus the main aim of this prospective, multicentric, observational study is to determine the incidence of "difficult" or "failed" SGA placement in children and clarify the possible risk factors for difficulty.

NCT ID: NCT05832944 Recruiting - Clinical trials for Laryngeal Mask Airway

Hyomental Distance Measured Ultrasonography Versus Weight-based Criteria for Laryngeal Mask Size Selection in Children

Start date: June 2023
Phase: N/A
Study type: Interventional

- In pediatric surgery and emergencies, LMA represents a useful airway management device for routine and difficult airway management. - Inserting an improper LMA size may result in malposition, displacement within the hypopharynx, and failed ventilation that needs repositioning. - Selection of the size of LMA represents a major challenge for anesthesiologists, especially in children. - The ultrasonographic measured hyomental distance showed a correlation with the length of the pharyngeal cavity. - Optimization of the size of the inserted LMA can be confirmed either clinically, ultrasonographic or through the fiberoptic laryngoscope. - The ultrasonographic measured hyomental distance confirmed the optimization of LMA with results comparable to that of the clinical methods and better than those of the fiberoptic laryngoscope.

NCT ID: NCT04910659 Recruiting - Pain, Postoperative Clinical Trials

Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

the aim of our study is to investigate if stimulation of the P6, LI4 and LI11 acupuncture points via laser acupuncture prevents sore throat caused by the classic laryngeal mask.

NCT ID: NCT04872881 Not yet recruiting - Clinical trials for Intubation, Intratracheal

Comparison of Effectiveness of Different Airway Management Methods During Percutaneous Tracheostomy

Start date: May 1, 2021
Phase: Phase 4
Study type: Interventional

Tracheostomy is a vital procedure in the ICU to maintain the airway and prevent complications that may occur due to intubation. It helps reduce the dead space volume, airway resistance and provides comfort to the patients during the weaning from mechanical ventilation. Two methods are widely used in Percutaneous Dilatational Tracheostomy (PDT): The multiple dilation method (Ciaglia) and the Griggs method.Griggs method will be used in the study. The Griggs Method: A 10-15 millimeter skin incision is made between the level of the second-third tracheal rings. The location of the needle is confirmed by entering the trachea with an injector filled with 2-3 mL saline from the midline and aspirating air. A J-tipped guidewire is advanced through the needle and the needle is removed. A special forceps with a channel at the tip, through which the guidewire can pass is used in this method. The forceps advanced through the guidewire and then subcutaneous tissues and trachea are dilated in one or two steps. When the stoma is large enough to insert the cannula, it is placed in the trachea and fixed. Patients who will undergo tracheostomy in the ICU will be included in the study and randomly assigned into two groups. Two different methods, endotracheal tube (ET) or laryngeal mask (LMA), will be used during the tracheostomy for airway management. In both methods, fiberoptic bronchoscopy will assist the procedure. Researchers aim to compare the two airway management methods in terms of complications, procedure time, and the number of staff needed.

NCT ID: NCT04795544 Completed - Clinical trials for Laryngeal Mask Airway

Three Inflation Methods of Ambú Auragain™ and Its Adverse Effects

Start date: January 18, 2021
Phase: N/A
Study type: Interventional

Laryngeal mask is a common supraglottic device (SGD) used in the daily practice for airway management. Consecutive generations have permitted an expansion of its use. At the moment, the SGD is being used in several situations, which include general anesthesia, cardiopulmonary resuscitation, and difficult airway management. To insert the SGD safely in these situations, the Fourth National Audit Project has encouraged the use of second-generation SGD equipped with the passage of a nasogastric tube. Ambu Auragain™ is a recent second-generation SGD with an incorporated gastric drainage channel and the capability of working as a conduit for tracheal intubation. It has higher leak pressure than the ones of first generation, which is a key marker of efficacy and safety of its use; a higher leak pressure suggests a better seal between the artificial airway and patient's airway. However, there are still few reports of which volume of cuff is the most appropriate for it use. The cuff inflating volume is not standardized and it is common practice to inflate the SGD cuff according to the manufacturer's recommendations, without using a manometer. A hyperinflation of the laryngeal mask cuff was associated with complications ranging from sore throat, or dysphagia and dysphonia, to more serious complications such as paralysis of the vocal cord, arytenoid cartilages dislocation, recurrent laryngeal nerve injury and hypoglossal nerve injury. Also, the excess of volume or pressure is related to poor ventilation and increase the risk of gastric insufflation. The aim of this study is to evaluate the best cuff inflation method, in order to limit the intracuff pressure beyond the recommended maximum pressure (PM < 60 cmH2O) and to allows decrease the pharyngo-laryngeal complications. The Primary outcome is to compare three different cuff inflating methods using Auragain™ laryngeal mask during fibro bronchoscopy and endobronchial ultrasound (EBUS) procedures, and to control the intracuff pressure, and the effect on pharyngo-laryngeal complications. The three different cuff inflating methods are: 1) residual volume group (RV group ) 2) half of the maximum volume group (MV group) 3) unchanged volume group (NV group)

NCT ID: NCT04769791 Completed - Clinical trials for Laryngeal Mask Airway

Three Inflation Methods of the Ambú Auraonce™ and Its Adverse Effects

Start date: July 17, 2017
Phase: N/A
Study type: Interventional

Laryngeal mask airway device (LMA) is a common device used in the daily practice for airway management. Consecutive generations have permitted an expansion of its use, probably because of a rapid increase of ambulatory surgical procedures and also due to the development of procedures in areas away from the operating room. The cuff inflating volume is not standardized and it is common practice to inflate the LMA cuff according to the manufacturer's recommendations, without using a manometer. A hyperinflation of the LMA cuff was associated with complications ranging from sore throat, or dysphagia and dysphonia, to more serious complications such as paralysis of the vocal cord, arytenoid cartilages dislocation, recurrent laryngeal nerve injury and hypoglossal nerve injury. Also, the excess of volume or pressure is related to poor ventilation and increase the risk of gastric insufflation. The aim of this study is to evaluate the best cuff inflation method, in order to limit the intracuff pressure beyond the recommended maximum pressure (PM < 60 cmH2O) and to allows decrease the pharyngo-laryngeal complications. The Primary outcome is to compare three different cuff inflating methods using AuraOnce™ LMA during fibrobronchoscopy and endobronchial ultrasound (EBUS) procedures, and to control the intracuff pressure, and the effect on pharyngo-laryngeal complications. The three different cuff inflating methods are: 1) residual volume group (RV group) 2) half of the maximum volume group (MV group) 3) unchanged volume group (NVgroup)

NCT ID: NCT04719767 Not yet recruiting - Surgery Clinical Trials

Application of Visual Laryngeal Mask Airway Combined With Endotracheal Intubation in General Anesthesia

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

To study the advantages of visual laryngeal mask combined with endotracheal intubation in general anesthesia surgery, we compared intubation time, intubation times and intubation success rate of endotracheal intubation through laryngeal mask airway under visual and non-visual conditions, at the same time, the laryngeal mask displacement rate, volume of secretion in airway, the incidence of laryngeal spasm, the incidence and severity of postoperative oropharyngeal pain were also compared between two groups.