Clinical Research Directory

Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients

This study compares two airway devices used during general anesthesia in children: a second-generation laryngeal mask (SafeLM LMA) and a third-generation video laryngeal mask (SafeLM Video LMA). Both devices are CE-marked and routinely used in clinical practice. The study will include 90 children aged 2 to 8 years who are scheduled for elective surgery. Children will be randomly assigned to one of two groups (45 per group), and one of the two devices will be placed after anesthesia induction. The main outcome is oropharyngeal leak pressure, which shows how well the mask seals the airway. Other outcomes include success at the first insertion attempt, number of attempts, view of the vocal cords (video group), heart rate and blood pressure changes, and complications such as laryngospasm, low oxygen levels, sore throat, hoarseness, and nausea/vomiting. The study aims to show whether video-guided placement improves airway seal and safety in children.

Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation

Effective respiratory ventilation is achieved by moving the right amount of air in 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 non-inferiority study, we will perform a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation.

Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy

The left head rotation (LeHeR) maneuver, in which the head of the supine patient is rotated 45° to the left, is a simple, equipment-free technique proposed to improve laryngeal view during laryngoscopy. Published results are conflicting: self-controlled studies report improvement, whereas parallel-group and large cohort studies do not. This prospective, observational, self-controlled study aims to compare the glottic view obtained in the standard sniffing position with that obtained in the 45° LeHeR position in the same adult patients undergoing elective surgery under general anesthesia with direct laryngoscopy. Glottic view will be graded with the modified Cormack-Lehane classification and the Percentage of Glottic Opening (POGO) score. Intubation difficulty, need for additional maneuvers or adjuncts, hemodynamic changes, and airway trauma will also be recorded.

LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway

The left head rotation (LeHeR) maneuver, in which the head of the supine patient is rotated 45° to the left, is a simple, equipment-free technique proposed to improve the laryngeal view. Studies using the Percentage of Glottic Opening (POGO) score during video laryngoscopy have reported improvement with LeHeR, but evidence is limited and the maneuver has not been systematically evaluated in patients with a predicted difficult airway. This prospective, observational, self-controlled study aims to compare the POGO score obtained in the sniffing position with that obtained in the 45° LeHeR position in the same adult patients with a modified El-Ganzouri Risk Index (EGRI) score above 4 undergoing elective surgery under general anesthesia with video laryngoscopy. Ease of intubation, number and duration of attempts, need for adjuvant maneuvers, hemodynamic changes, and airway trauma will also be recorded.

Comparison of the Ambu AuraGain and Intersurgical i-Gel Laryngeal Masks in Elective Laparoscopic Cholecystectomy

Prospective, controlled, randomized study to compare Ambu AuraGain with Intersurgical i-Gel mask during mechanical ventilation in patients undergoing laparoscopic cholecystectomy. The investigators hypothesise that when comparing the Ambu® AuraGainTM with Intersurgical i-GelTM mask, the Ambu® AuraGainTM would exhibit a higher oropharyngeal leak pressure (OLP) during mechanical ventilation in patients undergoing laparoscopic cholecystectomy. The main goal is to compare the Ambu AuraGain with the i-Gel in terms of safety and efficacy during mechanical ventilation in critical phase of the pneumoperitoneum in lateral decubitus and reverse trendelemburg position. Secondary objectives are comparing insertion time, number of attempts, ventilatory airway peak pressure, time and success rates for gastric tube insertion and the incidence of side effects.

Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion

This study aims to investigate whether the administration of a neuromuscular blocking agent (rocuronium) improves the anatomical positioning of a third-generation video laryngeal mask airway (video LMA) in adult patients undergoing elective surgery under general anesthesia. A laryngeal mask airway is a device placed in the throat to maintain an open airway and support ventilation during general anesthesia. The third-generation video LMA incorporates a camera that allows the anesthesiologist to visualize the laryngeal structures and assess device positioning during insertion. Neuromuscular blocking agents reduce muscle tone and may facilitate airway device insertion. However, their potential benefits for the positioning and performance of video LMAs remain unclear. This is a prospective, randomized, controlled, parallel-group, outcome assessor-blinded clinical trial. Eligible patients will be randomly assigned to one of two groups. Both groups will receive propofol and remifentanil for anesthesia induction. The intervention group will additionally receive rocuronium (0.6 mg/kg), while the control group will receive no neuromuscular blocking agent. The primary outcome is the proportion of patients achieving optimal anatomical positioning of the video LMA, defined as a Brimacombe score of 4 on the integrated video image. Secondary outcomes include oropharyngeal leak pressure, insertion time, first-attempt insertion success, number of insertion attempts, ease of insertion, hemodynamic changes, ventilation parameters, airway-related complications, and postoperative adverse effects.

Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children

This randomised controlled trial compares three supraglottic airway devices (laryngeal masks) in children with a body weight of 3-30 kg undergoing elective surgery under general anaesthesia: the SaCoVLM video laryngeal mask (UE Medical), which has an integrated camera allowing visual confirmation and adjustment of mask position, the LMA Supreme (Teleflex) and the Ambu AuraGain (Ambu). Children are randomly assigned in a 1:1:1 ratio to one of the three devices. The main question is whether the SaCoVLM provides a higher oropharyngeal leak pressure (a measure of how well the mask seals the airway) than the LMA Supreme and the Ambu AuraGain. Secondary questions include first-attempt insertion success, the need for repositioning or reinsertion of the mask during surgery and airway-related complications.

A Novel Score for Procedural Difficulty During Videolaryngoscopic Intubation

Videolaryngoscopy generally improves the glottic view compared with direct laryngoscopy, yet a good view does not always translate into easy delivery of the tracheal tube. Existing classifications describe either the laryngeal view (Cormack-Lehane grade, percentage of glottic opening) or the overall difficulty of intubation (Intubation Difficulty Scale), but none characterizes which specific mechanism produces difficulty during videolaryngoscopic intubation. This observational study evaluates a component-based score developed to describe procedural difficulty encountered during videolaryngoscopic tracheal intubation. The score comprises four components, each graded 0 to 2 (total range 0 to 8): view-tube concordance, restricted epiglottic movement, need for additional laryngoscopic manoeuvres, and need for tube-shaping adjustment. Adult patients undergoing elective surgery under general anaesthesia with tracheal intubation performed using a Macintosh-blade videolaryngoscope were assessed. The primary objective is to examine the association between the total score and procedural outcomes: intubation time, number of attempts, and first-attempt success. Secondary objectives include the relationship of the score with the Intubation Difficulty Scale, the Video Classification of Intubation, percentage of glottic opening, preoperative airway assessment parameters and operator experience.

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.

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.

SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision

This randomized controlled trial compares the airway management performance of the SafeLM video laryngeal mask with the LMA Classic in adult patients undergoing elective fibroadenoma excision under general anesthesia. Participants will be randomly assigned to airway management with either the SafeLM or the LMA Classic. The primary outcome is oropharyngeal leak pressure. Secondary outcomes include insertion performance, ventilation parameters, hemodynamic responses, and airway-related adverse events.

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.

Bronchoscopic Versus Airway Exchange Catheter-Guided Endotracheal Tube Exchange

This prospective experimental study compares two methods for replacing an endotracheal tube in Thiel-embalmed body donors. The conventional method uses an airway exchange catheter based on the Seldinger technique, whereas the investigational method uses a flexible bronchoscope to provide direct visual guidance throughout the exchange. The primary outcome is the duration of interrupted ventilation, measured from cessation of ventilation until ventilation is resumed through a correctly positioned replacement tube. Secondary outcomes include unsuccessful tube exchange requiring complete reintubation, duration of individual procedural steps, procedures lasting more than 60 seconds, use of additional rescue equipment, and unforeseen technical difficulties. Both techniques will be performed in two Thiel-embalmed donated human bodies using an alternating sequence. Four experienced physicians will perform 40 tube exchanges per technique, resulting in a total of 80 procedures.

REMIfentanil (2 vs. 4 mcg/kg) Facilitated Intubation Without Neuromuscular Blockade Versus Succinylcholine and Rocuronium With Sugammadex for Endotracheal Intubation in Spine Surgery Requiring Motor Evoked Potential Monitoring

The purpose of this research is to compare four commonly used anesthesia medication strategies for placing a breathing tube in patients undergoing spine surgery that requires motor evoked potential (MEP) monitoring.

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.

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.