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NCT07470736
This study titled "Comparative Study Between Combined Video Laryngoscope and Video Stylet Intubation Versus Combined Video Laryngoscope and Fibreoptic Intubation in a Simulated Difficult Airway" aims to evaluate and compare two advanced intubation techniques used in managing difficult airways. Currently, there is no study in Malaysia that compares the combination of a video laryngoscope (VL) with a video stylet (VS) and the combination of VL with a fibreoptic bronchoscope (FOB). Although both methods have been investigated separately, direct comparisons in simulated difficult airway settings are limited. The findings of this study will help guide airway management protocols and improve clinical outcomes in challenging airway situations. This is a single-centre, randomized comparative crossover trial conducted at the Department of Anaesthesiology and Intensive Care, HCTM, UKM. Ethical approval will be obtained from the departmental and university ethics committees prior to commencement. The study population will consist of anaesthesiology medical officers with at least two years of experience and anaesthesiology trainees in their second to fourth year of training at HCTM, UKM. Participants with severe hand tremors or those who decline participation will be excluded. The main objectives are to compare the first-pass intubation success rate, time to successful intubation, and operator-rated ease of intubation between the two combined techniques. Each participant will perform both VL with VS and VL with FOB intubations in a simulated difficult airway scenario. The study hypothesizes that the combined VL with VS technique will provide superior performance, a higher first-pass success rate, shorter intubation time, and greater ease of use compared to the VL with FOB technique. Participants who fail to complete all procedures or withdraw after participation will be considered dropouts. The results from this study are expected to provide useful insights into the effectiveness and practicality of these two combination techniques for airway management training and clinical application.
NCT07384494
Study Background Airway management is one of the most fundamental and critical technical procedures in anesthesiology, critical care, and emergency medicine. Difficult airway management remains a major challenge in these fields, particularly when a "cannot intubate, cannot ventilate" scenario occurs during the induction of general anesthesia. Such events can rapidly lead to hypoxemia, resulting in brain injury or even death, and have become a significant source of anesthesia-related severe complications and medical disputes. Awake tracheal intubation (ATI) is considered the gold standard for airway management in patients with anticipated difficult airways, as it preserves spontaneous breathing and thereby reduces the risk of catastrophic airway failure during anesthesia induction. However, despite routine supplemental oxygen administration, hypoxemia remains one of the most common and potentially serious complications during ATI. When low-flow oxygen therapy (\<30 L/min) is used, the reported incidence of hypoxemia (SpO₂ ≤ 90%) ranges from 12% to 29%. Once hypoxemia occurs during ATI, it may not only interrupt the procedure, increase the number of intubation attempts, and reduce the likelihood of successful intubation, but also trigger serious cardiovascular events, thereby compromising patient safety. High-flow nasal cannula (HFNC) oxygen therapy can deliver heated and humidified gas at flow rates of up to 70 L/min and improve oxygenation and ventilation through mechanisms such as anatomical dead space washout, reduction of work of breathing, and generation of continuous positive airway pressure. HFNC has been shown to improve oxygenation in a variety of medical and procedural settings. However, evidence regarding the role of HFNC during awake tracheal intubation remains controversial and of low quality. There is an urgent need for well-designed multicenter randomized controlled trials specifically focused on the ATI setting, using hypoxemic events as the primary outcome and applying strictly standardized procedures, to provide high-quality evidence on the effectiveness and safety of HFNC during ATI. Such evidence is essential to inform clinical practice and support future updates of airway management guidelines. Study Hypothesis This study hypothesizes that, in patients with anticipated difficult airways undergoing ATI, HFNC is more effective in preventing intubation-related hypoxemic events than conventional low-flow nasal cannula oxygen therapy. Study Objectives Primary Objective: To evaluate the effectiveness of high-flow nasal cannula oxygen therapy compared with conventional low-flow nasal cannula oxygen therapy in preventing hypoxemia during ATI in patients with anticipated difficult airways. Secondary Objectives: To assess the effects of high-flow nasal cannula oxygen therapy versus conventional low-flow nasal cannula oxygen therapy on procedural outcomes of awake tracheal intubation, including the rate of interventions required after hypoxemia, first-attempt intubation success rate, number of intubation attempts, overall ATI success rate, intubation time, and the incidence of adverse events. Study Methods This study is a multicenter, randomized controlled clinical trial. Adult patients undergoing ATI will be recruited from six tertiary hospitals in China. Participants will be randomly assigned to receive either high-flow nasal cannula oxygen therapy or conventional low-flow nasal cannula oxygen therapy throughout the intubation procedure. The study will compare the incidence of hypoxemia between the two groups and further evaluate intubation success rates, intubation time, the need for rescue interventions following hypoxemia, and the incidence of adverse events.
NCT07222007
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.
NCT06986187
A difficult airway is a clinical condition that occurs when one or more of the components of difficult mask ventilation, difficult laryngoscopy, difficult endotracheal intubation, difficult supraglottic airway device (SGA) placement, and inability to intubate-oxygenate are present. Data concerning incidence of difficult airway in patients undergoing cardiovascular surgery is controversial. Unwanted hemodynamic changes that may occur in patients undergoing cardiovascular surgery, combined with hemodynamic changes caused by underlying cardiac pathologies, may also lead to a physiologically difficult airway situation. Since all these interactions, combined with the hemodynamic changes caused by difficult airway interventions, may lead to catastrophic outcomes, it is vital to predict difficult airway in this patient population.
NCT06401486
Tracheal intubation (TI) is one of the fundamental and most recognized techniques in Anesthesiology, also essential in all units treating urgent pathology and critical patients. It involves advancing a tube through the vocal cords into the trachea to ventilate the patient. In thoracic surgery, it is often necessary to achieve lung isolation, ventilating only one lung while the operated lung remains collapsed and immobile. To achieve this, it is common to intubate the patient with a special tube: a double-lumen tube (DLT), larger than usual because it provides two ventilation channels, one for each lung. Tracheal intubation with a DLT presents some peculiarities: its larger size and stiffness make manipulation and orientation in the oropharynx difficult. It has a curve at its distal end (the bronchial lumen) designed to slide into the left or right main bronchus as needed. The fact that the DLT passes between the vocal cords does not ensure its proper placement and function. Therefore, DLT intubation requires practice and experience, both to slide it between the vocal cords and to position it properly. The classic technique for DLT intubation is "Direct Laryngoscopy" (DL). A traditional laryngoscope with a Macintosh blade is used to move the upper airway structures aside to allow direct visualization of the glottis. In recent years, to facilitate tracheal intubation, different videolaryngoscopes have appeared. A videolaryngoscope is a device similar to a traditional laryngoscope that allows, thanks to an image sensor located at its end, indirect visualization of the glottis on an integrated or external screen. There is strong evidence for the benefit of using a VL over traditional DL in single-tube intubation in adult patients. However, although the use of VL for DLT intubation is becoming more common, there are few studies with small sample sizes comparing VL to DL for DLT intubation, so the evidence of its advantages or disadvantages is of low quality. It could improve glottic exposure and the percentage of success on the first attempt, although there is a possibility of increased tube malposition incidence and delayed intubation. Therefore, Investigators propose a prospective, multicenter, randomized study comparing the traditional Macintosh blade laryngoscope (direct laryngoscopy) with the videolaryngoscope to facilitate orotracheal intubation with double-lumen tube in patients scheduled for thoracic surgery requiring lung isolation.
NCT04716218
In patients with limited neck extension and mouth opening due to reasons including previous radiation therapy in the head and neck area or cervical spine pathology, tracheal intubation with direct laryngoscopy (DL) are challenging because of the difficulty in aligning the oral, pharyngeal, and laryngeal axes in order to visualize the cords. In contrast, video-laryngoscopes (VL) only require alignment of the pharyngeal and laryngeal axes, which lie along much more similar angles when compared with the oral axis. Thus, VL make tracheal intubation easier to accomplish in these patients. Good patient positioning also maximizes the chance of successful laryngoscopy and tracheal intubation. In difficult airway society 2015 guidelines, advantages of head-up positioning and ramping, which brings the patient's sternum onto the horizontal plane of the external auditory meatus (EAM), are highlighted. In the obese patient, the 'ramped' position should be used routinely because this improves the view during DL. This position is usually achieved by placing blankets or other devices under the patient's head and shoulders, but can also be achieved simply by configuring the operation room (OR) table into a back-up head elevated (BUHE) position. Significantly improved glottic views on DL have been reported with both obese and non-obese adult patients in BUHE position. However, the effect of this simple maneuver on laryngeal visualization with the VL in patients with limited neck extension and mouth opening has not been reported. The investigators hypothesized that BUHE position might improve laryngeal views and make intubation easier compared to the supine position with the VL in patients with simulated difficult airway (application of a cervical collar to limit mouth opening and neck movement).The investigator investigated primarily the improvement in visualization of the glottis and, secondarily, the ease of tracheal intubation after alignment of the EAM and sternal notch.
NCT05178212
A subset of patients with COVID-19 develops acute respiratory failure and acute respiratory distress syndrome (ARDS) (1). The use of invasive mechanical ventilation for the treatment of these conditions is associated with high mortality rates (2,3). The use of high-flow nasal oxygen therapy (HFNO) and awake prone position (AW-PP) could to decrease the need for endotracheal intubation and other adverse clinical outcomes (4-6). The aim of this study is to evaluate the clinical results of the simultaneous application of high-flow nasal oxygen therapy HFNO and awake-prone position in a cohort of patients with severe respiratory failure secondary to COVID-19 on relevant clinical outcomes, and to assess risk factors of treatment failure defined as requirement of invasive mechanical ventilation.
NCT06881576
Use of VCI in Spain
NCT02527083
Research suggests that the type of anesthesia used for surgery may affect intraoperative stress hormone levels. There is also data to support that an increased level of stress hormones leads to increased pain after surgery. The primary aim of this study is to determine the effect of anesthesia type on long term pain after hernia surgery. In this study, patients undergoing inguinal hernia repair will be randomized to an anesthetic group, either Total Intravenous Anesthesia (TIVA) maintained with propofol or Balanced Inhaled Anesthesia (BIA) maintained with sevoflurane. This will allow us to look at any differences in short and long-term pain after hernia repair depending on type of anesthesia received.
NCT07054138
This study aims to evaluate the effect of preoperative dexmedetomidine nebulization on blunting hemodynamic response for laryngoscope, intubation, pneumoperitoneum, and opioid consumption in morbidly obese patients undergoing laparoscopic bariatric surgery.
NCT06091631
Magnesium sulfate has many mechanisms of action for attenuating the stress response as inhibition of catecholamine releasing from the adrenal medulla, keeping the plasma concentration of epinephrine at a fixed level, decreasing the circulating norepinephrine level when compared to that of a control group\[ and also has a vasodilation effect on systemic and coronary blood vessels by blocking calcium ion in vascular smooth muscle.-Methyl- D-Aspartate (NMDA) antagonism is an amazing recent discovery for magnesium sulphate to play an important role in stress response. In this study, we will study the effects of nebulized magnesium sulfate on hemodynamics during intubation.
NCT07278232
1. Study Purpose This research aims to develop a novel, non-invasive, and simple method to predict difficult intubation before surgery. The core idea is that the anatomy of a person's throat and mouth, which determines the ease of intubation, also uniquely shapes their voice. By analyzing the acoustic features of specific vowel sounds using machine learning, we seek to identify voice patterns associated with difficult airways. The ultimate goal is to create a tool that allows for a quick, painless pre-operative risk assessment, enhancing patient safety by better preparing anesthesiologists. 2. Study Design This is a prospective, observational, single-center study. It is purely observational and does not involve any changes to standard medical care or anesthesia procedures. 3. Participants We plan to enroll 300 patients. Who can join: Patients aged 15-70 scheduled for elective surgery requiring general anesthesia with tracheal intubation. Who cannot join: Individuals with speech/hearing impairments, significant neurological diseases affecting speech, or conditions contraindicating standard laryngoscopy. 4. Study Procedures For participants, the study involves one key procedure in addition to standard care:Voice Recording: Before surgery, participants will be asked to lie down and pronounce the vowels "a," "e," and "i" steadily for 1-2 seconds. This will be done twice: once with the head in a normal position and once with the head tilted back. A high-quality recorder will capture the sounds. This process is painless and takes only a few minutes. Standard anesthesia and intubation will then proceed as usual. The anesthesiologist will record the laryngeal view obtained during intubation, which will be used to classify the case as "difficult" or "non-difficult" for analysis. 5. Data Analysis The primary goal is to determine if there are statistically significant differences in the key voice resonance frequencies (F1, F2, F3) between the difficult and non-difficult intubation groups. Advanced machine learning models will be built to create the predictive algorithm. 6. Risks and Benefits Benefits: There is no direct medical benefit to participants. The contribution is to future medical knowledge and patient safety. Risks: The study involves minimal risk. The voice recording is non-invasive and safe. The main risk is the potential loss of confidentiality, which is mitigated by strict data protection protocols. 7. Confidentiality \& Ethics All patient data will be de-identified and stored securely. The study protocol and informed consent form have been approved by the Institutional Ethics Committee of Shanghai Sixth People's Hospital. Participation is voluntary, and participants may withdraw at any time without affecting their medical care. Written informed consent will be obtained from every participant before any study procedures.
NCT07130123
The aim of this clinical trial is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation. Participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.
NCT06648759
Abdominal surgery, laparoscopic or open, is frequently performed at UPMC Shadyside hospital. One of the most frequent complications following abdominal surgery is a postoperative ileus. Although postoperative ileus may be the result of obstruction or leakage, in most cases postoperative ileus (POI) is the result of local irritation because of fluid overload, exogenous opioids, neurohormonal dysfunction, gastrointestinal stretch, local bleeding and inflammation. POI usually lasts between 2 to 7 days. In most cases, a nasogastric tube (NG tube) is used to relieve that gastric pressure until the resolution of the POI. The placement of a NG tube can lead to a local trauma, bleeding and pain. Pain represents a major complaint among those with POI, often contributing to prolonged hospital stays.
NCT07256834
The goal of this clinical trial is to compare the incidence of postoperative sore throat in adult patients of either gender belonging to ASA I or II ,undergoing endotracheal intubation using betamethasone gel versus lidocaine gel. It aims to determine 1: Difference in efficacy of Betamethasone gel and lidocaine gel in prevention of post operative sore throat after endotracheal intubation. Patients will be assessed for the presence of a sore throat at 6 hours and 24 hours postoperatively. The severity of the sore throat will be graded using the Post-Operative Sore Throat (POST) score.
NCT06683599
Tracheal intubation in neonates can be technically challenging, even for experienced pediatric anesthesiologists, with a high first-attempt success rate crucial to ensure safety. Intubation, while life-saving for children with circulatory shock or respiratory failure, carries risks of severe desaturation that can lead to hypoxic encephalopathy, cardiac arrest, or death. Neonates, especially, are prone to hypoxemia due to high oxygen consumption, low functional residual capacity, small closing capacity, and increased risk of airway collapse, which is exacerbated under anesthesia and neuromuscular paralysis. Rapid desaturation occurs after cessation of ventilation, with neonates facing shorter apnea times before desaturation. Studies show that about two-thirds of neonates undergoing non-emergency nasotracheal intubation experience desaturation (SpO₂ \<80% for over 60 seconds), although low-flow oxygen supplementation (0.2 L/kg/min) can extend safe apnea time. This study aims to investigate apneic oxygenation with VL (using Miller or Macintosh blades size 0 or 1) in operating rooms or intensive care units. We hypothesize that supplemental oxygen and standardized VL use will improve first-pass success rates and reduce adverse events.
NCT07152093
This prospective observational study aims to develop an artificial intelligence model that can automatically determine the Cormack-Lehane classification from video laryngoscopy images in patients undergoing elective surgery. It also aims to predict the risk of difficult intubation based on this classification. The resulting data will evaluate the applicability of AI-supported decision support systems in clinical airway management.
NCT06139809
The goal of this study is to perform a quality control assessment of our local intubation protocol in any newborn infant requiring endotracheal intubation in the delivery room or neonatal intensive care unit at the Department of Neonatology of the University Hospital Zurich. The primary aims are: * Successful nasal intubation at the first attempt without physiological instability. * Comparison of infants with successful intubation at the first attempt without physiological instability to the infants in the SHINE-Trial in Australia. Participants will be intubated according to our standard intubation procedure using non-invasive ventilation (NIV) delivered through a nasopharyngeal tube.
NCT06981923
Patients undergoing bariatric surgery often present challenges during intubation due to limited neck mobility, increased soft tissue in the airway, and elevated body mass index (BMI). Predicting difficult intubation in these patients is critical to ensuring safety. The Simplified Airway Risk Index (SARI) by Ganzouri is a validated tool for predicting difficult intubation. It considers factors like neck mobility, Mallampati score, and body weight, which are highly relevant in difficult airway prediction in the bariatric population. The CMAC video laryngoscope is widely used to manage difficult airways. Two commonly used devices are the CMAC D-Blade, designed explicitly for difficult airways, and the CMAC Video stylet, which combines video guidance with a flexible tip. This study will compare the efficacy and safety of these two devices in bariatric patients with an anticipated difficult airway, as identified by the SARI.
NCT07146984
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.