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.

Effect of Laryngeal Mask Cuff Shape on Pharyngeal Stress

Laryngeal masks are widely used supraglottic airway devices, but their cuffs differ considerably in shape and design. The cuff exerts pressure on the pharyngeal structures, which may provoke a physiological stress response and contribute to postoperative pharyngeal complaints. This prospective, randomized, two-centre trial compares three commercially available laryngeal masks with different cuff designs (SaCoVLM, LMA Supreme and Ambu AuraGain) in 162 adult patients undergoing elective surgery under general anaesthesia. Anaesthesia induction is standardized and guided by State Entropy, and cuff pressure is standardized to 40-50 cmH2O in all groups. The primary outcome is the change in mean arterial pressure after laryngeal mask insertion. Secondary outcomes include heart rate, nociception and depth-of-anaesthesia indices (Surgical Pleth Index, Response Entropy - State Entropy difference), insertion characteristics, oropharyngeal leak pressure and postoperative pharyngolaryngeal complaints up to 24 hours. The hypothesis is that cuff shape modifies the stress exerted on the pharynx and thereby influences the patient's stress response.

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.

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.

Airway Changes in Patients Undergoing Elective Surgical Procedures in the Prone and Trendelenburg Positions

The goal of this study is to track the intraoperative changes that occur in the airways of patients undergoing 1) laparoscopic surgeries in the Trendelenburg position, and 2) spinal surgeries in the prone position, as well as the regression of these changes postoperatively. These surgeries are known to cause edema and swelling of the soft tissues of the head and neck, temporarily worsening airway anatomy, but there is little data quantifying these changes, and no studies have investigated the time course required for the airway to return to its baseline after extubation. This would be important clinical information given that airway management is always a major concern perioperatively. The investigators will test hypotheses by evaluating patients' airways preoperatively, immediately post-extubation, and at regular intervals thereafter using the Modified Mallampati Score class (MMS), in which a patient's airway is scored from class 1 to 4 (in which 4 indicates the highest likelihood of a difficult intubation) based on the visibility of the soft palate, uvula, and faucial pillars inside the oral cavity.

Difficult Airway Management in Oncology: An International Delphi Consensus Study (DAMO)

Airway management in patients with cancer carries risks that general difficult-airway guidelines do not address. Tumour in the head, neck, or mediastinum can distort or narrow the airway; previous radiotherapy causes fibrosis and restricts neck movement; low platelet counts increase bleeding during instrumentation; and obstruction may sit below the point at which a breathing tube ends, so that intubation alone does not restore ventilation. Existing international airway guidelines are written for general populations and contain little cancer-specific guidance. This study uses a modified Delphi method to develop an international expert consensus statement on the prediction, preparation for, and management of the difficult airway in adults with cancer. An international panel of clinicians with expertise in anaesthesiology, intensive care, interventional pulmonology, head and neck surgery, and emergency medicine votes anonymously on a set of candidate statements across ten clinical domains, using a seven-point agreement scale with free-text comment. Voting takes place over a minimum of three rounds. Between rounds, panellists receive anonymised group results and a summary of comments, and statements are revised accordingly. Consensus is defined a priori as agreement by at least 80 percent of respondents together with a median score of 5 or above; strong consensus requires at least 90 percent agreement with a median of 6 or 7. Statements that do not reach consensus are reported as such and form a prioritised research agenda. Reporting follows the ACCORD reporting guideline for consensus methods.

Effects of Video LMA Cuff Pressure in Tympanoplasty.

This prospective observational study aims to evaluate the effects of different cuff pressure levels of the Video Laryngeal Mask Airway (Video LMA) on airway safety, ventilation efficacy, and postoperative pharyngeal symptoms in patients undergoing tympanoplasty surgery. Patients are evaluated in two groups based on the measured Video LMA cuff pressure: 50 cm H2O or lower, and higher than 50 cm H2O. The primary outcome is oropharyngeal leak pressure (OLP). Secondary outcomes include the incidence and severity of postoperative pharyngeal symptoms, such as sore throat, dysphagia, and hoarseness, assessed during the first 24 hours postoperatively. Video LMA provides visual confirmation of correct anatomical position, allowing the effects of cuff pressure to be evaluated independently of device malposition.

Effect of Neuromuscular Blockade on Video Laryngeal Mask Airway Ventilation

This prospective, randomized, double-blind study aims to evaluate the effect of different degrees of neuromuscular blockade on the performance of a video laryngeal mask airway (LMA) during general anesthesia. Participants will be randomly assigned to receive rocuronium at 0, 0.3, or 0.6 mg/kg, corresponding to 0, 1, or 2 times the ED95, respectively. The primary outcome is oropharyngeal leak pressure measured after LMA insertion. Secondary outcomes include LMA insertion conditions, insertion time and number of attempts, laryngeal view, respiratory parameters, and postoperative airway-related complications.

Effect of Night Shift Versus Daytime Duty on Tracheal Intubation Complications and Duration in Surgical Patients

Airway management is one of the most critical steps of anesthesia, and its complications can be life-threatening. Reduced staffing, differences in personnel experience, and physical and mental fatigue during off-hours (evenings, nights, weekends, and holidays) may affect the quality of care and patient safety - a phenomenon described in the literature as the "after-hours effect." While this effect has been studied for outcomes such as cardiac arrest and intensive care mortality, evidence specific to airway management safety remains limited. This prospective observational cohort study aims to evaluate the effect of shift timing on the safety and efficiency of tracheal intubation in adult surgical patients undergoing general anesthesia at a single center. Based on the actual start time of anesthesia, patients will be categorized into an in-hours group (08:00-16:00) or an off-hours group (16:01-07:59), without any investigator-assigned intervention. The frequency and type of intubation-related complications, intubation duration, and the pre-intubation sleepiness level of the performing anesthesiologist (assessed using the Karolinska Sleepiness Scale) will be compared between groups. The investigators hypothesize that intubations performed during off-hours are associated with a higher complication rate and longer intubation duration than those performed during in-hours. Approximately 1000 patients will be enrolled over a period of up to 2 years.

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.

Comparative Analysis of a Preoperative Airway Ultrasound Protocol and Direct Laryngoscopy in Oncologic Surgery Patients

This prospective observational study evaluated the predictive performance of the Difficult Airway Evaluation with Sonography (DARES) protocol for identifying difficult laryngoscopy and other airway management difficulties in adult patients undergoing elective oncologic surgery. Preoperative airway ultrasonography was performed together with conventional clinical airway assessment. Ultrasound parameters included the distance from skin to epiglottis (DSE), hyomental distance (HMD) measured in different head positions, hyomental distance ratios (HMDR1 and HMDR2), and tongue thickness (TT). Conventional airway assessment parameters were also recorded. The primary objective was to evaluate the ability of ultrasound-derived airway parameters to predict difficult laryngoscopy, defined as a Cormack-Lehane grade \>2a (grades 2b, 3, or 4) during direct laryngoscopy, and to compare their predictive performance with conventional clinical airway assessment methods. Secondary objectives included evaluating the relationship between ultrasound parameters and difficult mask ventilation, assessed using the Han scale; investigating their relationship with difficulties or complications encountered during extubation; and exploring differences in airway ultrasound parameters and their predictive performance across oncologic patient subgroups.

Comparison of Three Airway Intubation Devices for First-Attempt Success in General Anesthesia Patients

The goal of this clinical trial is to compare three airway intubation devices in adult patients undergoing general anesthesia who require tracheal intubation. The main questions it aims to answer are: * Does the SPHJ-II video-assisted adjustable red-light fluoroscopic tracheal intubation scope improve first-attempt intubation success compared with a visual lighted stylet and a visual intubation fiberscope? * How do the three devices compare in intubation efficiency, intubation-related complications, and peri-intubation physiological responses? Researchers will compare the SPHJ-II, the visual lighted stylet, and the visual intubation fiberscope to evaluate their performance during tracheal intubation. Participants will be randomly assigned to one of the three device groups and undergo tracheal intubation during general anesthesia using the assigned device.

Hyperangulated Video Laryngoscopes Used for Intubation With Simultaneous Cervical Spine Immobilization

This study will evaluate four videolaryngoscopes used for intubation of patients with cervical spine immobilization. Two hundred adult patients (females and males) with ASA (American Society of Anesthesiologist) status 1-3 will be scheduled for elective laparoscopic surgery at the Mazowiecki Szpital Specjalistyczny in Radom, Poland. Patients with known difficult laryngoscopy, difficult face mask ventilation, with previous history of awake tracheal intubation, those aged under 18 years or patients with BMI \> 30 kg m-2 will be excluded from the study. All patients will receive oral premedication with 7.5 mg midazolam 30 minutes before the start of anaesthesia. A standard monitoring will be applied. This consists of ECG, NIBP (non-invasive blood pressure), SpO2, TOF (train-of-four) and volatile anaesthetic concentration. In order to achieve cervical spine immobilization, a Patriot® cervical collar (Össur hf., Reykjavik, Iceland) will be applied. The size of the collar will be adjusted to the patient's anatomy. Furthermore, the cervical collar will be fixed to allow a minimal mouth opening of 20 mm. All patients will be placed in a neutral position and will be pre-oxygenated with FiO2 1.0 for three minutes prior to induction. Anaesthesia will be induced with fentanyl (1-2 µg ml-1) and propofol (2-3 mg ml-1). Rocuronium (0.6 mg ml-1) will be used as a neuromuscular blocking agent. Adequate neuromuscular block will be confirmed and controlled throughout the procedure with TOF Watch (Organon, Dublin, Ireland). A cuffed, size 7.5 tracheal tube with stylet (Sumi, Sulejówek, Poland) will be used for intubation. A single-use hyperangulated blade will be used in all studied devices. Correct placement of the tracheal tube will be confirmed by videolaryngoscopy, capnography and chest auscultation. All patients will be anaesthetised by experienced consultant anaesthetists with over 10 years of clinical practice after completion of specialist training. Furthermore, all anaesthetists participating in the study will be trained beforehand with all VLs used until they feel competent. Only two intubation attempts with a studied videolaryngoscope will be allowed. A single attempt will be limited to 60 seconds. A failure is defined as an attempt which lasts more than 60 seconds, when saturation drops below 90%, after two unsuccessful attempts, when airway injury or bronchospasm occurrs. A single-digit number will be allocated to each of the studied videolaryngoscopes: 1 for the C-MAC PM, 2 for the McGrath, 3 for the VisionPro and 4 for the AceScope. A single sheet of paper containing printed number will be placed in an opaque envelope. Then they will be assigned to the participating anaesthetist by computer-generated randomization. The SPSS 29.0 software (IBM, Armonk, NY, USA) will be used for allocation. Furthermore, patients will be blinded to randomization.

Novel Integrated Tube-Bougie Prototype for Endotracheal Intubation in Airway Simulation

Endotracheal intubation is a critical airway management procedure that frequently requires adjunctive devices, such as stylets or elastic bougies, to facilitate successful tube placement. Although videolaryngoscopy has become increasingly common, access to videolaryngoscopes remains limited in certain clinical settings, particularly in prehospital and resource-constrained environments. Consequently, stylets and bougies continue to play an essential role in airway management. To address this need, we developed a novel integrated tube-bougie prototype that combines the guidance function of an elastic bougie with an endotracheal tube into a single device. This prospective, randomized, crossover simulation study is designed to compare the performance of the integrated tube-bougie prototype with conventional stylet-assisted and elastic bougie-assisted endotracheal intubation. Emergency medicine residents will perform intubations using all three techniques in both normal and difficult airway simulation scenarios according to a randomized crossover sequence. The primary outcome is the time to successful endotracheal intubation. Secondary outcomes include first-attempt intubation success, perceived procedural difficulty assessed using a visual analog scale (VAS), incidence of esophageal intubation, dental trauma, and evaluation of the learning curve using cumulative sum (CUSUM) analysis. The findings could contribute to the development of alternative airway assistive equipment for emergency airway management and training.

The Effect of Ultrasonographic Airway Measurements and Anatomical Differences on Laryngeal Mask Placement in Young and Older Adults

This prospective observational study aims to compare ultrasonographic upper-airway measurements and age-related anatomical differences between young adults (18-40 years) and older adults (\>65 years), and to evaluate their effects on laryngeal mask airway (LMA) placement success and position accuracy. Preoperative airway ultrasonography measurements will be assessed, followed by evaluation of LMA placement, ventilation efficacy, insertion attempts, placement time, and complications. Ultrasonography will also be used to assess LMA position after placement, with confirmation by leak testing and fiberoptic evaluation. Preoperative and postoperative gastric volume will additionally be assessed.

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.

Artificial Intelligence-Assisted Ultrasound Assessment of Laryngeal Mask Airway Placement

This prospective observational study aims to develop and evaluate artificial intelligence-based models for the assessment of laryngeal mask airway (LMA) placement in adult patients undergoing elective surgery under general anesthesia. Following LMA insertion, standardized airway ultrasound images will be obtained and fiberoptic assessment will be performed as the anatomical reference standard. Fiberoptic findings will be classified as optimal (Brimacombe grades 3-4) or suboptimal (grades 1-2). Clinical and quantitative airway ultrasound variables will also be recorded. The predictive performance of tabular, image-only, and multimodal artificial intelligence models will be evaluated for identifying optimal versus suboptimal LMA placement.

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.

Application of Lateral Position Digestive Endoscopy-Guided Endotracheal Intubation in Anesthesia for Endoscopic Diagnosis and Therapy

This case series study evaluated whether placing a breathing tube using a camera (gastrointestinal endoscope) is safe and effective for patients lying on their left side during stomach and intestine exams under anesthesia. The main questions were: How often does the tube placement work on the first try? How long does it take to place the tube? Are there any safety issues, like injuries or breathing problems? Researchers enrolled 40 adults needing anesthesia for stomach/intestine exams. All participants had the breathing tube placed while lying on their left side using the camera-guided method. The steps included: Positioning the patient on their left side with head/neck support. Inserting a lubricated camera through the mouth to view the throat. Placing the breathing tube into the windpipe under direct camera view. The method avoided the risks of moving anesthetized patients from their back to the side. It may reduce risks linked to repositioning patients during surgery. Future studies with more participants and different medical teams are needed to confirm these results.

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.

Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone

Effective respiratory ventilation is achieved by moving the right amount of air to and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone.

First Attempt Success in Tracheal Intubation Through Supraglottic Airway Devices Without Fiberoptic Guidance

This randomized controlled trial aims to compare the first-attempt success rate of tracheal intubation through supraglottic airway devices using a conventional intubating supraglottic airway device versus a video-assisted supraglottic airway device without fiberoptic guidance in adult patients undergoing elective surgery under general anesthesia. A total of 204 participants will be randomly assigned to one of the two groups. The primary outcome is the first-attempt success rate of tracheal intubation through the supraglottic airway device. Secondary outcomes include intubation time, number of intubation attempts, overall intubation success, hemodynamic changes, airway-related complications, postoperative sore throat and hoarseness, and adverse events. The results of this study may help identify a safe and effective airway management strategy when fiberoptic bronchoscopy is unavailable.

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.

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.