Clinical Research Directory

Ventilation Safety in Beach Chair Shoulder Surgery: SafeLM Versus I-gel

This study aims to compare the performance of SafeLM™ video laryngeal mask airway and i-gel® supraglottic airway device in patients undergoing shoulder surgery in the beach chair position under general anesthesia. The primary objective is to evaluate oropharyngeal leak pressure (OLP) within the first 10 minutes after transition to the beach chair position. Secondary objectives include assessment of ventilation safety, need for airway interventions, and postoperative airway-related complications. This prospective randomized study will provide data on the effectiveness and safety of a video-guided supraglottic airway device compared to a conventional device in a clinically challenging position.

Blind Intubation Through the Tulip Airway Versus Direct Laryngoscopy

This is a randomized crossover mannequin study comparing two airway management techniques in novice operators: blind endotracheal intubation via the Tulip oropharyngeal airway versus direct laryngoscopy. The study aims to evaluate and compare the success rate and performance characteristics of both methods under simulated conditions in order to assess their effectiveness in airway management training and practice.

Success of Laryngeal Mask Airway (LMA) Insertion During Continuous Chest Compressions in Neonatal Resuscitation: A Randomized Crossover Simulation Study

The purpose of this study is to evaluate the time required for laryngeal mask airway (LMA) insertion, first-attempt success rates, and airway sealing quality (air leak) during neonatal resuscitation with and without interrupting chest compressions. Standard resuscitation guidelines recommend pausing chest compressions for airway interventions due to the difficulty of inserting devices during physical movement. However, interrupting compressions drops coronary and cerebral perfusion. This study tests whether an LMA can be successfully inserted without pausing compressions in a high-fidelity simulation model. A total of 32 anesthesiologists participate in this randomized, crossover simulation study using a high-fidelity neonatal manikin. Participants perform two different scenarios in a randomly allocated order: Scenario A involves standard LMA insertion with interrupted chest compressions, and Scenario B involves LMA insertion during continuous, uninterrupted chest compressions. The primary objective is to determine if performing the procedure under continuous chest compressions affects the procedure time, clinical success, air leak volumes, or the perceived workload and stress of the practitioners.

I-scoop vs. C-Mac D-Blade Videolaryngoscope for Airway Management Under Spontaneous Breathing and Analgosedation

The purpose of this clinical trial is to investigate whether the videolaryngoscope i-scoop makes airway management under spontaneous breathing and analgosedation more clinically practicable than the established standard device, the C-Mac D-Blade videolaryngoscope, in adults undergoing surgery under general anesthesia. The main questions it aims to answer are: • Is good clinical practicability - defined as a successful, easy, and complication-free intubation under spontaneous breathing - more frequently achieved with the i-scoop than with the C-Mac D-Blade? Researchers will compare the standardized airway management procedure under spontaneous breathing using either the i-scoop or the C-Mac D-Blade. Participants will: * continue breathing on their own during the procedure * be randomly assigned (1:1) to one of the two videolaryngoscopes * receive standardized analgosedation and topical lidocaine anesthesia of the upper airway before the breathing tube is placed * be asked about discomfort and recall of the procedure after surgery (in the recovery room, on postoperative day 1, and at 7 days post-intubation) by a blinded interviewer

Bedside Ultrasound for Confirmation of Endotracheal Tube Placement in the Emergency Department

This prospective observational study evaluated the role of bedside ultrasound in confirming endotracheal tube placement in adult patients who underwent endotracheal intubation in the emergency department. Correct placement of the endotracheal tube is critical because unrecognized incorrect placement may cause hypoxemia, hypoxic brain injury, or death. In this study, bedside ultrasound was performed during or immediately after endotracheal intubation without interfering with the intubation procedure. Ultrasound findings were compared with capnographic end-tidal carbon dioxide measurement, which was used as the reference method for confirming tube placement. The main aim was to assess whether bedside ultrasound is a useful and reliable method for confirming endotracheal tube position in emergency department patients.

Evaluation of Anterior Neck Ultrasound in Predicting Difficult Airway in Obese Patients

Obese patients are at increased risk of difficult airway management due to anatomical changes in the anterior neck soft tissues. Accurate preoperative prediction of difficult airway remains challenging using conventional clinical airway assessment tests alone. This prospective observational study aims to evaluate the role of ultrasound assessment of anterior neck soft tissue thickness in predicting difficult airway risk in overweight and obese adult patients undergoing elective surgery under general anesthesia. Ultrasound-based anterior neck measurements will be compared with standard clinical airway assessment parameters to determine their diagnostic accuracy for difficult laryngoscopy and intubation. The results of this study may contribute to improved preoperative airway risk stratification and safer airway management in obese patients.

Mental Rehearsal in Emergency Cricothyroidotomy Training

Medical staff at the clinic will participate in standard cricothyroidotomy training supplemented with structured mental rehearsal exercises in order to evaluate the usefulness and effectiveness of this approach as a training tool.

Multifunctional Oropharyngeal Airway and Hypoxemia in Sedated GI Endoscopy: A Multicenter RCT

This multicenter, prospective, randomized controlled trial aims to evaluate whether a novel multifunctional oropharyngeal airway (MOPA) reduces the incidence of hypoxemia in 1,518 adult patients (ASA I-II, aged 18-80 years) undergoing elective sedated gastrointestinal endoscopy. Patients are randomized 1:1 to receive either the MOPA (which integrates oxygen delivery, PETCO₂ monitoring, and airway support) or conventional nasal cannula with standard mouthpiece. The primary endpoint is the incidence of hypoxemia (75% ≤ SpO₂ \< 90% for \<60 seconds) during the procedure. Secondary outcomes include severe hypoxemia, hypercapnia, PETCO₂ monitoring success, airway interventions, adverse events, and satisfaction scores. The study is conducted across 29 centers in China, with centralized randomization via an EDC system, blinded outcome assessment, and statistical analysis using a two-sided alpha of 0.05 (power 90%). Results are expected to provide high-level evidence for optimizing airway management during sedated endoscopy.

Airway Management Skills Amongst Anesthesia Providers

The aim of this study is to evaluate the efficiency and proficiency of three common airway management techniques amongst among anesthesia providers who maintain airway management privileges in our health system.

Effective Dose of Alfentanil Combined With Propofol for Laryngeal Mask Airway Insertion in Children

This study uses a prospective, up-and-down sequential allocation method to determine the median effective dose (ED50) and 95% effective dose (ED95) of alfentanil combined with propofol for successful laryngeal mask airway (LMA) insertion in children aged 7-12 undergoing elective day surgery.

Taiwan ED Airway Quality Surveillance Registry (TEAR)

This prospective, multicenter observational registry systematically captures all emergency department tracheal intubations across participating hospitals in Taiwan. The registry focuses on process quality indicators, including first-pass success, and patient-safety outcomes, including hypoxemia, hypotension, and peri-intubation cardiac arrest within 30 minutes of intubation. Routinely generated laboratory and physiologic variables are also collected to improve risk stratification and identify predictors of major adverse events. The study is non-interventional and does not alter clinical care.

Upper Airway Ultrasound Evaluation

Current guidelines support the use of predictive clinical tests in the evaluation of difficult airway, meaning either difficult bag and mask ventilation, conventional laryngoscopy and/or endotracheal intubation. However, despite the clinical use of these predictive tests, unpredictive difficult laryngoscopy complicates 1.5-13% of cases. Life threatening scenarios may be encountered in patients with difficult or impossible bag and mask ventilation. Anaesthesiologists are familiar with the use of ultrasound, with peripheral nerve blockade and central vascular access representing the most popular applications during the last decades. The ultrasound provides real time and accurate images. According to the current literature, there are only a handful of studies relevant to the application of point of care ultrasound (POCUS), as a new tool in the upper airway evaluation. It is a new field of research with high interest. This is a prospective observational study to investigate if specific ultrasound measurements of the anterior neck can serve as predictors of difficult airway. The ultrasound parameters will be measured preoperatively, during the preanaesthetic evaluation, along with standard clinical prognostic tools, like the mallampati score. The ultrasound parameters to be investigated are: 1. the distance from thyroid isthmus to skin surface, 2. the distance from the hyoid bone to the skin surface, 3. the distance from the anterior commissure of vocal cords to the skin surface, 4. the distance from skin to the trachea at the level of jugular notch, 5. the distance from skin to epiglottis corresponding to half of the distance between thyroid cartilage and hyoid bone, 6. and the angle between glottis and epiglottis. After the induction in anaesthesia, the Cormack Lehane score (grading of the laryngoscopy view) and the Han scale (grading of the degree of difficulty of bag and mask ventilation) will also be recorded. The goal of this study is the investigation of the role of POCUS in the evaluation of difficult bag and mask ventilation and difficult intubation. The primary endpoint is the incidence of difficult bag and mask ventilation and the incidence of difficult laryngoscopy and intubation. Secondary endpoints are the correlations between clinical prognostic tools of difficult airway and the POCUS parameters under investigation.

LMA I-Gel Versus LMA Protector During Minor Urological Procedures Under General Anesthesia in Adult Patients

This will be a randomized comparative study comparing the two supraglottic devices i-gel and Protector, intraoperatively, during minor urological procedures under general anesthesia in adult patient.

Comparison of Two Airway Devices (I-Gel and Air-Q) in Children Aged 1-10 Years During General Anesthesia

This study aims to compare two commonly used airway devices (I-gel and Air-Q) in children aged 1-10 years undergoing general anesthesia for surgery. These devices help doctors keep the airway open and support breathing during the operation. The study will evaluate how well each device works, how easy they are to place, and whether they cause air to enter the stomach. Ultrasound will be used to safely check the position of the device and detect any air in the stomach. The results of this study may help improve the safety and effectiveness of airway management in children during anesthesia.

Evaluation of SaCoVLM™ Video Laryngeal Mask for Airway Management in Military Medics

A prospective, two-phase interventional study evaluating the performance, safety, and usability of the SaCoVLM™ video laryngeal mask airway for airway management by military medics with limited intubation experience. The study includes simulation-based training and clinical application in sedated patients undergoing elective surgery.

Induction Agent Choice With Early Mortality and Prognostic Outcomes in Critically Ill Patients

The aim of this retrospective cohort study is to compare the safety and efficacy of induction agents for tracheal intubation in critically ill adult patients.

Clinical Study on the Efficacy of Subglottic Suction in Mechanically Ventilated Patients Guided by Bedside Ultrasound

Subglottic suctioning, as an important airway management technique, has its operational accuracy and safety directly impacting patient prognosis. Therefore, improving the effectiveness and safety of subglottic suctioning has become a focus of clinical attention. Point-of-care ultrasound, which can provide imaging, can be used to guide subglottic suctioning, enhancing the intuitiveness of the procedure. This study aims to evaluate the safety and effectiveness of subglottic suctioning guided by point-of-care ultrasound in mechanically ventilated patients, in order to help standardize clinical practice and improve medical quality.

Pediatric Airway: Noninferiority Trial of Devices for Intubation Assessment

The goal of this clinical trial is to find out whether the BESDATA BD-DF videolaryngoscope works as well as the McGRATH™ MAC videolaryngoscope for placing a breathing tube in infants during surgery. The study will also compare the costs associated with using each device. The main questions this study aims to answer are: Is the BESDATA BD-DF videolaryngoscope as effective as the McGRATH™ MAC videolaryngoscope for successful placement of a breathing tube on the first attempt in infants? Are there differences between the two devices in terms of procedure time, number of attempts, airway-related complications, and overall costs? Researchers will compare infants who are intubated using the BESDATA BD-DF videolaryngoscope with infants who are intubated using the McGRATH™ MAC videolaryngoscope to see whether the two devices perform similarly and whether one is more cost-effective than the other. Participants will: Be randomly assigned to have a breathing tube placed using one of the two videolaryngoscopes; Receive standard general anesthesia for an elective surgical procedure; Have information collected during and after the procedure to assess safety, effectiveness, and costs.

Virtual Reality: a Teaching-learning Strategy for Cognitive Mastery in Airway Trauma Management

Airway injury in patients is a high risk and complex medical crisis. Unfortunately, training for airway management in injured patients is challenging. The most effective way of practicing airway management is using mannequins. However, mannequin training is expensive and only occasionally available to medical trainees. The purpose of this study is to determine if Virtual Reality (VR) can be used to educate medical students on airway injury management. VR training will involve managing the care of a patient with an airway injury in an immersive, interactive VR hospital trauma bay. The investigators will compare the knowledge gained from VR training vs. mannequin training. The investigators will also investigate whether VR training teaches students faster than mannequin training. In addition, the investigators will identify factors which might affect learning from VR. Medical students who choose to participate will be randomized (i.e. participant will have a 50% chance to be placed in either group) to be trained with VR or a mannequin. Participants then will be trained on airway injury management using their assigned training approach. One week later, all participants will be assessed on their airway injury management skills using a mannequin. Before and after their sessions, participants will also be asked to complete a questionnaire on their clinical decision-making. Participants who received VR training will also complete a questionnaire about their experience with the VR training. This study will help develop a new approach to airway management training which is cheaper and more easily available to medical trainees than mannequin training. This educational tool could lead to better treatment of airway trauma in future patients.

Videolaryngoscopic Difficult ıntubation and Glottic View Score: A Multicentre Prospective Study

Background: Videolaryngoscopy has improved glottic visualization and facilitated tracheal intubation. However, difficulties-including failed intubation-still occur. At present, no prospectively derived classification system exists to assess the difficulty of videolaryngoscopic (VL) intubation across both normal and anticipated difficult airways. Additionally, current glottic view grading systems, designed for direct laryngoscopy, may not adequately capture the specific challenges of VL intubation. Objectives: This study aims to: 1. Develop a predictive model for difficult VL intubation in surgical patients with both normal and anticipated difficult airways. 2. Create a glottic view scoring system specifically tailored to videolaryngoscopy. 3. Compare the predictive accuracy of the new scoring system with existing laryngeal view grades in forecasting difficult VL intubation.

The 90% Effective Ventilation Pressure (EP90) for Esophageal Insufflation Avoidance During Anesthesia Induction

Exploring the 90% Effective Ventilation Pressure (EP90) for Esophageal Insufflation Avoidance During Anesthesia Induction: The aim is to determine the optimal ventilation pressure for esophageal insufflation avoidance during anesthesia induction and to explore its guiding significance for anesthesia management. The goal is to provide a more precise and personalized ventilation pressure setting standard for clinical anesthesia, thereby enhancing the safety of the anesthesia induction phase.

Prehospital Emergency Airway Research.

The creation of an airway registry will allow an improvement in the quality of care, the safety of critically ill patients in pre-hospital situations, and a reduction in morbidity and mortality related to airway management.

Two Video Laryngoscopes (Laringocel® and C-MAC®) for First-Attempt Intubation in Adults Undergoing Elective Surgery

This study will test two video laryngoscopes that help doctors place a breathing tube during surgery. A breathing tube is needed for people who receive general anesthesia so they can breathe safely. Video laryngoscopes use a small camera to give a better view of the throat and vocal cords, which may help the tube go in on the first try. The purpose of this research is to find out if a Colombian device called Laringocel® works as well as the widely used international device C-MAC D-Blade® (Karl Storz). If Laringocel® performs similarly, it could be a more affordable option for hospitals with limited resources. 252 adults (126 in each group) who need elective surgery at Alma Máter Hospital de Antioquia (Medellín, Colombia) will take part. Each participant will be randomly assigned, like flipping a coin, to have their breathing tube placed with either Laringocel® or C-MAC D-Blade®. Only trained anesthesiologists will perform the procedure. The study will look at: Main goal: how often the tube goes in correctly on the first attempt. Other goals: overall success within 3 attempts, how well the airway is seen, how long the intubation takes, how satisfied the doctor is with the device, and possible side effects such as sore throat, dental injury, or oral injury. Participation will not change the usual care people receive during anesthesia. Both devices are already approved for clinical use. Risks are the same as with any standard intubation, and participants will be checked after surgery for any problems. By comparing these two devices, researchers hope to learn if Laringocel® can provide safe and effective intubation at lower cost, improving access to advanced airway tools.

Data-driven Development of a Core Dataset for Difficult Airway Alerts

Previous difficult airway management is the most accurate predictor of future difficulty. Consistent documentation is paramount for future airway planning, but requires reliable, reproducible and easily accessible information. Currently, anaesthesia alert cards are often based on analogue hard copies while they lack a clinically meaningful core data set allowing structured reproducible documentation and risk estimation. Further, existing alert cards are often inconsistently used and clear triggers for issuing of airway alert cards are widely undefined. The FingAIRprint project aims to develop a justifiable core data set using a data-driven approach in patients undergoing tracheal intubation with videolaryngoscopy or direct laryngoscopy, that is intended to be used for documentation of digital airway alerts.