Clinical Research Directory

Video Versus Direct Laryngoscopy for Tracheal Intubation in Pediatric Surgery

Tracheal intubation in paediatric patients is a high-risk procedure in which failure to achieve successful intubation on the first attempt is associated with an increased risk of complications, including hypoxaemia and airway trauma. Videolaryngoscopes have been increasingly adopted in clinical practice because they improve glottic visualisation; however, evidence of their benefit in paediatric patients remains inconsistent (1) The VIDEOKIDS trial is a large, pragmatic, international, multicentre, randomised controlled trial designed to compare videolaryngoscopy with direct laryngoscopy as the initial technique for tracheal intubation in paediatric patients undergoing surgery under general anaesthesia. The primary objective is to determine whether videolaryngoscopy increases the rate of successful intubation on the first attempt compared with direct laryngoscopy. (1) Koepp-Medina G, Lusardi AC, Di Fonzo B, et al. Videolaryngoscopy versus direct laryngoscopy for paediatric tracheal intubation: systematic review and meta-analysis. Br J Anaesth 2025;135:1486-98.

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.

Combined Ultrasonographic Skin-to-Epiglottis Distance With Modified Mallampati Versus Modified Mallampati Score Alone in Predicting Difficult Laryngoscopy During Tracheal Intubation Under General Anesthesia

This study will evaluate how well an ultrasound measurement of the distance from the skin to the epiglottis, when combined with the modified Mallampati score, can predict difficult laryngoscopy in adult patients undergoing elective surgery under general anesthesia. Adult patients scheduled for surgery requiring tracheal intubation will be randomly assigned to two assessment strategies before anesthesia: one group will have the usual bedside airway assessment with modified Mallampati alone, and the other group will have modified Mallampati plus a quick, painless ultrasound scan of the front of the neck to measure the skin-to-epiglottis distance. During intubation, the anesthesiologist, who is blinded to the preoperative assessments, will grade the laryngoscopic view using the Cormack-Lehane classification, and the investigators will compare how accurately each assessment approach predicts difficult laryngoscopy (grade 3-4). The study does not change how anesthesia or airway management is performed; ultrasound and clinical assessments are added solely for measurement and data collection, with minimal risk to participants and potential future benefits in improving airway risk stratification and patient safety.

Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation

Globally, we are approaching 1 million surgical procedures each day. Tracheal intubation is the mainstay of securing the patient's airway and breathing during general anaesthesia. Approximately 100.000 tracheal intubations are performed annually in Denmark. Airway management remains the primary reason for anaesthesia-related morbidity and mortality. It has been traditionally accepted that best tracheal intubation conditions are obtained by paralysing the patient's muscles, including vocal cords, using a neuromuscular blocking agent (NMBA) such as rocuronium. However, using NBMA may increase the risk of pulmonary complications, intra-operative awareness, in which the patient is paralysed but awake during surgery, anaphylaxis, and re-intubation. In addition, there is a risk of residual neuromuscular blockade postoperatively. In the US, prolonged ventilation and unplanned intubation are the top two most costly perioperative complications. An alternative to NMBA is a large dose of opioids to depress laryngeal reflexes during intubation. The most commonly used non-NMBA modality includes bolus administration of remifentanil. However, remifentanil may cause bradycardia and hypotension. Even short periods of hypotension have been shown to increase the risk of myocardial injury and other serious adverse events such as renal failure, delirium, and even mortality. Evidence also indicates that intubation conditions using only opioids to facilitate intubation, including remifentanil, are inferior to NMBA. However, these trials are underpowered to assess effects on patient-important outcomes and are mostly at high risk of bias. A recent trial has suggested that remifentanil intubation conditions may not be very different. Almost all existing research comparing NMBA to opioids has focused on intubation conditions for direct laryngoscopy using a conventional Macintosh laryngoscopy blade. In recent years, the implementation and availability of the video laryngoscope have grown exponentially and become universal. The video laryngoscope has vastly improved the ease of tracheal intubation, and the number of failed intubations has decreased by two-thirds in Denmark, where a rapid implementation of the video laryngoscope took place. However, limited evidence exists on whether NMBA improves intubation conditions compared to remifentanil when performing video laryngoscope-assisted tracheal intubation.

Tracheal Cuff Pressure and Postoperative Complications: A Prospective Observational Study.

This prospective observational study aims to identify risk factors for tracheal mucosal injuries caused by orotracheal tube use during the intraoperative period in patients undergoing elective surgeries at the Hospital de Clínicas de Porto Alegre. The study will recruit patients sequentially for elective procedures requiring general anesthesia and orotracheal intubation. Primary outcomes include symptoms such as hoarseness, pharyngolaryngeal pain, cough, and hemoptysis, assessed up to 30 days post-surgery. A risk score for tracheal injuries will be derived.

Optimisation Strategy for Emergency Tracheal Intubation

This study has to objective to assess, in adults' patients needing tracheal intubation because of vital distress, the effect of a combined strategy to reduce intubation-related morbidity. This strategy will associate systematic use of rocuronium as paralyzing agent to facilitate tracheal intubation, bag face-mask ventilation before intubation and Gum Elastic Bougie (GEB) use.

Application of PDCA Cycle in Tracheal Intubation Training for Emergency Medicine Residents

Tracheal intubation is a critical but technically demanding procedure in emergency airway management. Junior emergency medicine residents often struggle to achieve proficiency, leading to increased risks of complications. This study evaluates the effectiveness of a Plan-Do-Check-Act (PDCA) cycle-based training program in improving intubation skills. The study was conducted in the emergency department of a tertiary teaching hospital. Residents performing intubations in 2023 with conventional training served as the control group, while those trained with the PDCA model in 2024 formed the intervention group. The PDCA program included structured lectures, high-fidelity simulation, supervised clinical practice, and iterative feedback. Primary outcomes were first-attempt success rate and intubation completion time. Secondary outcomes included incidence of local airway trauma, extubation failure due to airway injury within 72 hours, and resident satisfaction. This study aims to provide evidence that PDCA-based training can enhance procedural competency, safety, and learner satisfaction in emergency airway management.

Comparison of Intubation Using Video Laryngeal Mask and Video Laryngoscope in Elective Surgical Patients

This study compares two airway devices that are commonly used during elective surgery: the video laryngeal mask airway (VLM) and the video laryngoscope (VLS). Both are part of routine anesthesia practice. Our main focus is to measure how long intubation takes with each device and to see how successful the intubation is. The study does not involve any extra procedures or risks; everything will be carried out as part of normal patient care.

Simple Mechanical Device to Control Pressure in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia

Hypothesis: Nosten® device is able to reduce the time of underinflated balloon and removes excess pressure. This device may thus reduce the risk of ventilator-acquired pneumonia (VAP) and early tracheal lesions resulting from intubation with decreased discomfort, morbidity, and nursing workload. The main objective of the investigators is to show that Nosten® device is more effective than monitoring and manual inflation of the balloon of the tracheal tube to prevent VAP occurrence.

Low-Cost Model Versus Airway Part-Task Trainer for Flexible Bronchoscope-Guided Tracheal Intubation Training

Background: Awake flexible bronchoscope-guided tracheal intubation (FBTI) is crucial in managing challenging airway situations. As the gold standard for difficult airway management, FBTI is essential for anesthesiologists to navigate anatomical complexities effectively. Training in FBTI requires theoretical understanding, hands-on practice, and experience. Skill acquisition and knowledge must reach an appropriate level before trainees perform on patients. Simulated scenarios offer a controlled environment for practitioners to develop muscle memory and problem-solving skills without risking patient safety. However, commercial simulators for FBTI are often expensive and inaccessible in many countries. Lebanon, a low- and middle-income country, currently faces a multifaceted economic and financial crisis. Hence, securing enough internal funds to support novice learners using available high-cost simulator training is challenging. Various low-cost simulators have been proposed in the literature, aiming to provide affordable training for novice anesthesiologists, particularly in regions where expensive simulators are scarce. Aim: This study aims to evaluate a low-cost, locally designed simulator by comparing skill acquisition and retention to a commercial airway part-task trainer in FBTI. Study design: Multicenter simulation-based randomized controlled trial (RCT) Methods: This simulation-based interventional clinical trial will include anesthesia PGY-I and PGY-II residents inexperienced in FBTI techniques from eight medical schools in Lebanon. The study comprises two main phases and one intermediate phase. Phase one is the development phase, whereby a Delphi approach will be utilized to develop a standardized Global Rating Scale for FBTI (LAU-modified SGR). The intermediate phase constitutes piloting the tool developed with LAU postgraduate trainees years 3, 4, and 5 from the pulmonology department, Ear, Nose, and Throat department, along with the anesthesiology residents. Phase two is the main RCT study whereby all participating residents will receive training on a theoretical course covering flexible bronchoscopy equipment, anatomy, indications, and complications, which will also be supplemented by a procedural video. After which residents will be randomly assigned to one of two groups. One group will undergo training on the locally designed low-cost model (RAN), whereas the other group will train on the airway part-task trainer. Participants' FBTI skills will be assessed using the high-fidelity CAS simulator and the LAU-modified SGR for FBTI to evaluate both theoretical and procedural fluency (i.e., retention of FBTI skills). Assessments will be conducted immediately after the training sessions, with follow-ups at three and six months. Significance: The utilization of low-cost simulators enables the integration of simulation training for healthcare professionals across diverse settings, facilitating skill transfer to clinical practice effectively at the lowest cost possible.

Endoscopy-Assisted Tracheal Intubation Versus Conventional Tracheal Intubation for Endoscopic Submucosal Dissection (ESD): a Prospective Randomized Controlled Study

This study plans to enroll 148 patients undergoing upper gastrointestinal endoscopic submucosal dissection (ESD). Patients will be randomly divided into a control group (conventional tracheal intubation) and an experimental group (endoscopy-assisted tracheal intubation). Patients meeting the inclusion criteria and not falling under the exclusion criteria will be invited to participate in the study. Upon providing voluntary consent, the research physician will arrange for the patient's inclusion in the study. After signing the informed consent form, the research physician will collect the patient's basic information, medical history, and other details, followed by timing the preoperative preparation period and evaluating postoperative discomfort

Mechanism of Nitric Oxide on Ventilator-induced Diaphragm Dysfunction with Extracorporeal Membrane Lung Assistance

The goal of this clinical trial is to explore the effect of NO treatment on diaphragm function after mechanical ventilation with ECMO assistance. We expect to enroll a total of 80 patients who will receive mechanical ventilation and mechanical ventilation combined with ECMO treatment. Depending on the indication, they will be given NO treatment or not. In ECMO assisted mechanical ventilation + NO treatment group, the subjects will be randomly assigned to NO treatment via ventilator or membrane oxygenator. The main questions it aims to answer are: 1. Observing the influences and potential therapeutic effects of different NO insertion methods through ventilator or membrane oxygenator on the occurrence and development of ventilator-induced diaphragm (VIDD) dysfunction during ECMO assisted mechanical ventilation. 2. Exploring the potential key molecular mechanisms of NO treatment on the occurrence and development of VIDD after ECMO assisted mechanical ventilation.

Postoperative Memories and Level of Sedation for Tracheal Intubation Using Fiberoptic Bronchoscopy/Videolaryngoscopy

Antecedentes In patients with expected difficult airways undergoing surgery, tracheal intubation must be performed with a fiberoptic bronchoscope or video laryngoscope while keeping the patient awake and under the effects of anesthetic sedation. Objective: To determine and compare the existence of postoperative memories of the patients and the different levels of sedation (Ramsay scale) obtained during the intubation procedure. Methods Prospective observational study that includes 100 patients older than 18 years who are going to undergo surgery, who need fiberoptic bronchoscopy/videolaryngoscopy for tracheal intubation due to the planned difficult airway and intravenous sedation. Patients with an unexpected difficult airway, under 18 years of age and/or with cognitive impairment will be excluded. After checking the tracheal intubation, the general anesthesia indicated for each patient will be used. Twenty-four hours after tracheal extubation, the patient will be questioned about the pain presented during the fiberoptic bronchoscopic/videolaryngoscopic procedure and postoperative memories based on a modified Brice questionnaire. At 30 days after surgery, the postoperative memories of the patients will be evaluated again by telephone interview.