Laryngeal Mask Airway (LMA) is a medical device used to maintain an open airway during anesthesia or emergency situations. Clinical trials involving LMA often evaluate its effectiveness and safety compared with other airway management techniques, ass...

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Found 9 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the use of portable dynamic digital radiography (DDR), a new advanced chest X-ray technology, in intensive care unit (ICU) patients. DDR captures dynamic images of lung motion, ventilation, and perfusion at a high frame rate, potentially providing more detailed and quantitative lung function information compared to traditional chest X-rays. This trial aims to test the feasibility and safety of portable DDR in the ICU and to compare its diagnostic value with current standard imaging methods. Participants will receive one to three sets of DDR scans, including 7-second breathing and breath-holding scans. These images will be compared to gold standard clinical exams such as chest X-rays, CT scans, or ventilation-perfusion (VQ) scans. The study will observe how DDR performs in diagnosing lung conditions like diaphragmatic dysfunction, pulmonary embolism, and pulmonary edema, alongside routine clinical imaging. Throughout the study, participants will undergo DDR imaging alongside their routine clinical imaging. Researchers will analyze these images to measure lung motion, diaphragmatic movement, and perfusion. The primary outcomes include assessing the precision of DDR in evaluating cardiopulmonary functions related to the diaphragm and lung motion as well as pulmonary blood flow, over a period of up to two months. The study will monitor safety and diagnostic accuracy while patients receive standard care.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating two airway devices, I-gel and Air-Q, in children aged 1 to 10 years undergoing general anesthesia for surgery. These devices help keep the airway open to support breathing during the operation. The study aims to compare how well each device works, how easy they are to place, and whether they cause air to enter the stomach, which can be an unwanted side effect. Ultrasound imaging will be used to safely check the device's position and detect any air in the stomach. Children in this study will be randomly assigned to receive either the I-gel or Air-Q supraglottic airway device during general anesthesia. The devices are selected based on the child's weight and placed according to standard clinical practice. Researchers will measure oropharyngeal leak pressure, insertion time, ease of insertion, and monitor for any complications. Ultrasound will be performed immediately after device placement, after patient positioning, and at the end of surgery to assess device position and gastric insufflation. Participants will undergo standard care with no additional risks beyond routine anesthesia. Data collected include measurements of airway sealing, device positioning, insertion details, and any complications from placement until discharge from the post-anesthesia care unit. The primary outcome is oropharyngeal leak pressure measured immediately after placement and at surgery end. The study may help improve airway device choice and safety for children during anesthesia. Total participation duration matches the surgical procedure and immediate recovery period.

Age: 1Year - 10YearsAll Genders
1 location
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Actively Recruiting

Researchers are investigating the effects of continuous monitoring and progressive regulation of inflatable laryngeal mask airway (LMA) cuff pressure on postoperative throat-related complications in elderly patients undergoing surgery. This study addresses a critical gap in research focusing on elderly patients, who face higher risks of pulmonary and throat complications during anesthesia due to natural physiological declines. It aims to improve airway management safety and effectiveness during the perioperative period by identifying the optimal cuff pressure range. The study is a prospective, single-center, randomized controlled trial comparing two groups of elderly patients receiving general anesthesia with LMA ventilation. One group receives continuous cuff pressure monitoring with progressive pressure regulation to maintain safe levels, starting at 40 cmH2O and adjusted downward during surgery. The other group receives empirical cuff inflation based on anesthesiologist experience, with pressure monitoring but no adjustments. Both groups undergo standard surgical procedures in the supine position with specific inclusion criteria including non-cardiac and non-thoracic surgeries. Participants will be monitored before, during, and after surgery for pharyngolaryngeal complications such as sore throat, hoarseness, mucosal injury, blood on the LMA, and swallowing difficulties. Additional assessments include difficulty and duration of LMA insertion, airway complications, pulmonary complications within 7 and 30 days post-surgery, hospital stay length, medical costs, and patient satisfaction. The study enrolls participants aged 60 and above, with a planned follow-up until at least 48 hours post-LMA removal, providing thorough evaluation of airway safety and recovery outcomes.

Age: 60Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

This research aims to compare two types of supraglottic airway devices, Ambu AuraGain and I-gel, in children aged 2 to 12 years undergoing elective orthopedic surgery under general anesthesia. The study focuses on measuring gastric insufflation volume and its relationship with oropharyngeal sealing pressure, which indicates how well the airway device seals and the risk of complications after surgery. Participants will be randomly assigned to receive either the Ambu AuraGain device or the I-gel device after anesthesia induction. Both devices serve as pathways for oxygen and anesthetic gases during surgery. The study evaluates outcomes like gastric antrum cross-sectional area at the end of surgery, leak pressure during the operation, time and attempts needed for insertion, and any postoperative complications within 24 hours. During the study, children will be monitored with assessments including ultrasound to measure the stomach area and tests for airway sealing pressure. Researchers will record details about device insertion and watch for any complications after surgery. Participation involves close observation during and shortly after surgery, with total involvement lasting through the surgical procedure and 24 hours afterward.

Age: 2Years - 12YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are studying the effectiveness of the IGEL laryngeal mask airway device in patients who have had radiation therapy to the neck. These patients face a higher risk of difficult mask ventilation and tracheal intubation during general anesthesia compared to most patients. The study aims to understand how well the IGEL device works as a rescue tool for maintaining oxygenation in this high-risk group, where failure to maintain oxygen can cause severe brain injury or death. The study involves inserting the IGEL device in anesthetized patients who have previously received radiotherapy to the neck. This device is being evaluated as a method to ensure adequate ventilation during surgery. The procedure is planned by physicians and is part of elective surgeries requiring general anesthesia. The study focuses on how successfully the device can be placed and used to ventilate the patient within a 10-minute timeframe. Participants will undergo the insertion of the IGEL device during their scheduled surgery. Researchers will assess the success of device placement and ventilation during this time. Data collected will focus on the effectiveness of airway control with this device in patients with previous neck radiation. The study does not involve blinding or comparison groups and will continue until September 2027. Participants are monitored closely to ensure safety during the procedure.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating whether using a supraglottic airway (SA) as the main interface for positive pressure ventilation (PPV) is feasible during delivery room resuscitation in premature infants born between 29 0/7 and 33 6/7 weeks' gestation. The study aims to determine if this method can effectively provide ventilation immediately after birth in these infants who require resuscitation. The study involves a single group of premature infants who need PPV at birth. These infants will receive ventilation through a supraglottic airway as the primary airway interface during delivery room resuscitation. The intervention is applied immediately after birth if resuscitation is required, focusing on the placement and use of the supraglottic airway. Participants will be screened before birth with parental consent obtained, then reassessed for eligibility at delivery. Clinical and procedural data will be collected during resuscitation and for up to 24 hours after birth. Researchers will measure the feasibility of using the supraglottic airway as the primary ventilation interface within the first 10 minutes of life, along with the timing and duration of airway placement during resuscitation.

Age: 0Days - 1DayAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating two different strategies to increase the use of supraglottic airway (SA) devices during neonatal resuscitation. This trial focuses on improving early SA rescue for newborns who require help establishing breathing at birth. Despite SA being approved and recommended for cases where facemask ventilation is difficult, its use remains low, and the study aims to understand how to better implement SA use in routine care to reduce risks of prolonged asphyxia and improve newborn health outcomes. The trial compares two approaches to support hospitals and providers in adopting SA use. One group receives an Enhanced Standard of Care involving educational materials, outreach, local champions, train-the-trainer programs, simulation training, and starter packs of SA devices. The other group receives all these components plus additional intensive external facilitation to further promote SA adoption. These strategies are delivered at hospital sites and evaluated over time. Participants include hospital staff involved in newborn resuscitation and newborns who receive positive pressure ventilation at birth. Data collection includes questionnaires and interviews with clinical providers and administrators, along with monitoring early SA rescue rates up to two years. The study measures initial adoption and sustainment of SA use, assessing both implementation and clinical outcomes. The trial runs from 2026 to 2029 and aims to identify barriers and facilitators for widespread SA use in delivery rooms.

Age: 0Days +All GendersPhase Not Applicable
30 locations
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Actively Recruiting

Researchers are evaluating the effect of using the McMurray Enhanced Airway (MEA), a flexible extended-length distal pharyngeal airway, on improving oxygen delivery during transesophageal echocardiography (TEE) procedures compared to the standard nasal cannula. This study focuses on patients undergoing TEE while sedated with propofol and aims to assess oxygenation performance during the procedure. Participants will be randomly assigned to one of two groups. One group will receive oxygen through the MEA device placed once in the oropharyngeal airway, delivering 40% oxygen at 6 liters per minute for up to 60 minutes during the TEE. The other group will receive oxygen via a standard nasal cannula during the same procedure time. Both devices are used during an in-person visit. During the study, researchers will monitor participants for the incidence of hypoxia, subclinical hypoxia, and severe hypoxia throughout the TEE procedure lasting up to 60 minutes. Participants will be assessed for oxygen levels and safety during the procedure. The total participation time corresponds to the duration of the TEE procedure with oxygen delivery and monitoring.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating the insertion success of two supraglottic airway devices, the classic Laryngeal Mask Airway (LMA) and the i-gel, in elderly patients over 75 years old undergoing elective urological surgery under general anesthesia. The study aims to compare these devices when used in different head and neck positions to provide guidance on the best airway management approach for older adults. The trial is a prospective, randomized, double-blind clinical study involving 120 patients with ASA physical status I-III. Participants will be randomly assigned to one of four groups: standard head position with i-gel, right lateral head rotation with i-gel, standard head position with classic LMA, or right lateral head rotation with classic LMA. The interventions include the use of the two airway devices in either a standard or rotated head position during surgery. The study will assess how easily and quickly the devices can be inserted in these positions. During the study, researchers will measure insertion time, number of attempts needed for placement, ease of insertion, hemodynamic responses, oropharyngeal leak pressures, fiberoptic scores, and any airway-related complications. These assessments will help determine which device and head position combination works best for airway management in elderly patients. The total duration of participation depends on the surgical procedure and anesthesia period.

Age: 75Years +All GendersPhase Not Applicable
1 location

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