28 Clinical Trials for Various Conditions
The purpose of this study is to compare two different ways of placing breathing tubes for surgery. Both ways are used currently to place breathing tubes and are safe and effective. This study seeks to determine if one way is better than the other for infants with pyloric stenosis.
The purpose of this research study is to help determine if the cuff of an endotracheal tube ( ETT) ( also known as a breathing tube)can be seen by ultrasound and to determine if visualization of this tube corresponds with correct tube depth. You are being asked to participate because you will be undergoing a cardiac catherization procedure which will involve endotracheal intubation. Ultrasound is a safe technology that your doctor could possibly use to see the breathing tube. Right now, x-rays, which come with their own risks, are being used for this purpose. We are trying to see if we can avoid using x-rays. This is a local study with 1 location. The study will enroll a total of 71 people. There is no sponsor for this study.
Patient demographics (age, height and weight) will be collected for 546 consecutive patients presenting for dental restoration under general anesthesia. The baseline saturation will be recorded. The induction of anesthesia will be standardized for all patients. All patients will undergo an inhalational induction administered by face mask. After inserting an intravenous (IV) line, rocuronium will be administered. Intravenous propofol and fentanyl could be added at the discretion of the anesthesiologist. The patients will be mask ventilated then be with a mixture of Air/Oxygen (O2) to achieve an FiO2 of 0.3 for 3 minutes after the administration of rocuronium. Patients will be randomly assigned to one of three groups for the purpose of airway management: 1) direct laryngoscopy for nasotracheal intubation without oxygen insufflation (DL group); 2) direct laryngoscopy for nasotracheal intubation with oxygen insufflation (DLO2 Group); and 3) nasotracheal intubation using the Truview PCD video laryngoscope (VL Group). Computer-generated treatment allocations (using the PLAN procedure in SAS statistical software, using random-sized blocks) will be maintained in sequentially numbered sealed envelopes that will be opened after consent is obtained. The laryngoscopy and intubations will be performed by the study investigators who are faculty anesthesiologists or by the mid-level or resident or fellow working with them. The study will be stopped when: * the patient will be intubated and a CO2 trace is obtained on the capnography or * if the patient desaturates to 90% * or if the patient shows signs of cardiac instability (ectopic beats, arrhythmia or hypotension) Randomized groups will be compared for balance on potentially confounding baseline variables using descriptive statistics. Primary outcome: In the primary hypothesis, desaturation will be characterized using both time to 1% saturation drop from the baseline and the rate (slope) of desaturation after an initial 1% drop. We will consider a given intubation technique (DLO2 or VL) better than DL on controlling saturation if found noninferior (i.e., not worse) on both outcomes and superior on at least one of the outcomes. Thus our primary hypothesis will be assessed in a joint hypothesis testing framework described by Mascha and Turan. We a-priori define the non-inferiority delta for the outcome time to 1% drop as 5 seconds (or 1.05 if using hazard ratio) and the slope delta as 0.05 percent per second.
The "sniffing position" is widely accepted as a favorable position for direct laryngoscopy (DL) in both pediatric and adult patients. External anatomical markers are well documented to confirm proper 'sniffing position' in adults, but data on their use in the pediatric population is sparse. The investigators propose to define these markers in young children and investigate whether patients positioned using this standardized approach have better intubating conditions than those positioned randomly per the preference of the anesthesiologist.
This study seeks to assess the role of the GlideScope Ranger video laryngoscope in facilitating successful neonatal/pediatric intubation by pediatric critical care transport teams. The central hypothesis of this study is that the GlideScope Ranger video laryngoscope reduces the rates of failed intubation attempts by pediatric critical care transport teams. The aims of this project are designed to specifically: (1) Establish competencies for GlideScope Ranger video laryngoscopy-assisted intubation for pediatric and neonatal patients; and (2) Compare the intubation success rates for intubation using GlideScope Ranger video laryngoscopy and using conventional, direct laryngoscopy by pediatric and neonatal critical care transport teams.
The purpose of the study is to implement a patient-provider dyad tailored, Electronic Health Record (EHR)-informed, digitized Smart Checklist as a Quality Improvement (QI) intervention to support bedside clinician teams to reduce Adverse Airway Outcomes (AAO) across 6 diverse pediatric intensive care units (ICUs).
Nasal intubation is frequently used for dental procedures to promote an unimpeded view of the oral cavity. A nasal RAE endotracheal tube is longer than a standard oral endotracheal tube (ETT) and it is shaped so that end of the tube which attaches to the ventilator exits upward toward the forehead. This unique shape ensures that the tube will not interfere with surgical exposure of the oral cavity and mandible. The nasal RAE ETT can be placed in the trachea using either direct laryngoscopy (DL) or video laryngoscopy (C-Mac) . Sometimes this is possible without an adjuvant, but frequently a pair of specially shaped forceps, known as Magill forceps, is required to guide the distal tip of the Nasal RAE into the glottis due to the curvature of these ETT. Magill forceps are introduced into the mouth and are used to grasp the distal end of the Nasal RAE and direct it into the glottis. Contrary to what the current literature suggests, it has been our experience that nasal intubations using the C-Mac frequently do not require the use of Magill forceps at nearly the same rate as DL. This technique may improve the time and ease to intubation because of not having to use the Magill forceps. The use of Magill forceps can be awkward for the clinician, with poor visualization due to obstruction of the view by this tool in the airway, and small working space within the posterior oropharynx. For these reasons, the possibility of not having to use Magill forceps because the investigators are using a C-Mac as the only tool to intubate is a potentially inviting one.
Advanced airway interventions are common high risk, high stakes events for children in intensive care units (ICU) and emergency departments (ED), with risk for life and health threatening consequences.
The purpose of this study is to determine the amount of propofol required to achieve 50% of patients obtaining a perfect ("excellent") intubation score of 5 on the Steyn modification of the Helbo-Hansen Intubation Score, when placing a tracheal tube in children 1-6 years and 6-12 years (division of age groups at 6th birthday) of age, under a specific induction and ventilation sequence as specified in this study design.
The investigators' primary specific aims are to demonstrate that: 1. Pediatric patients with normal airways, undergoing elective surgical procedures, can be successfully intubated when deeply sedated, without the use of muscle relaxants using the Shikani Optical Stylet. 2. Shikani intubation of pediatric patients is equally effective in children that are deeply sedated or paralyzed as evidenced by a non-significant difference in: * Time to intubation (defined as no more than a 30 second time difference between the two groups); * Incidence of adverse events.
The purpose of this study is to assess the impact of Just-In-Time (J-I-T) Rapid Cycle Deliberate Practice (RCDP) Simulation Training on laryngoscopy competency among novice pediatric anesthesia trainees.
This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management strategies in the care of critically ill children. Emergency Medical Services (EMS) agencies affiliated with the Pediatric Emergency Care Applied Research Network (PECARN) will participate in the trial. The study interventions are strategies of prehospital airway management: \[BVM-only\], \[BVM followed by SGA\] and \[BVM followed by ETI\]. The primary outcome is 30-day ICU-free survival. The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: \[BVM-only\] or \[BVM followed by SGA\]. The \[winner of Stage I\] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between \[BVM followed by ETI\] vs. \[Winner of Stage I\].
Nasotracheal Intubation with Videolaryngoscopy versus Direct Laryngoscopy in Infants (NasoVISI) Trial is a prospective randomized multicenter study. The study will be conducted at 8 centers in the United States. It is expected that approximately 700 subjects enrolled to product 670 evaluable subjects.The randomization is 1:1 naso tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct Laryngoscope (DL). The primary objective is to compare the nasotracheal intubation (NTI) first attempt success rate using VL vs. DL in infants 0-365 days of age presenting for cardiothoracic surgery and cardiac catheterizations.
The COVID-19 pandemic has disrupted anesthesia care all over the world. There remains very little data on current practice patterns and patient outcomes, particularly in anesthetized children. This is a prospective observational, multi-center study to investigate airway management related outcomes in children undergoing anesthesia during this pandemic. The investigators will compare the incidence of complications (particularly hypoxemia) in patients with COVID-19 to those who are COVID-19 negative during airway management. PAWS COVID-19 Registry https://is.gd/PEDICOVID19 Registration link https://is.gd/researchrequest
Klippel-Feil syndrome (KFS) was first described in 1912 by Klippel and Feil as a classic triad are comprised of a short neck, a low posterior hairline and restricted motion of the neck. This disease is considered as one of the congenital causes of difficult airway with the incidence of 1:42,000 live births. The current research findings suggested that the difficulties of airway management for KFS increases with age. In pediatric patients, the airway of those patients can be managed without difficulties. For adults, the fiberoptic-assisted intubation is also suggested. The purpose of this study is to review the airway management of pediatric patients with KFS to provide recommendation of airway management for these patients. A retrospective electronic chart review will be conducted by using Boston Children's Hospital (BCH) database, which identified patients with KFS who had undergone general anesthesia from June 2012 to June 2018.
The purpose of the study is to determine the impact of apneic oxygenation on the time to desaturation in pediatric patients treated in a pediatric intensive care unit (PICU). The investigators hypothesize pediatric patients will have an increase in time to desaturation with apneic oxygenation when compared to standard practice in the PICU.
The purpose of this study is to evaluate if intubation with video laryngoscopy (VL) will result in less head motion and therefore less cervical motion when compared with direct laryngoscopy (DL). The aim of the study is to determine the amount of head motion (extension, flexion and rotation) when using Storz C-Mac® video laryngoscopes and direct laryngoscopes. Secondarily, the study will also measure the number of attempts to properly intubate and the time required for intubation with either technique.
The study is a randomized crossover study where anesthesia practitioners will intubate three different pediatric infant mannequins (normal airway, anterior larynx, Pierre Robin syndrome anatomy) using three different intubation devices (the Miller blade, the Truview VL, the Glidescope Cobalt video-laryngoscope) in two different scenarios (normal neck and with an immobile neck). The order of presentation will be randomized. As this is a cross over study, all subjects will complete all scenarios. There is no placebo group, and each subject wil be his or her own control.
This study will evaluate using intraosseous vascular access and intravenous vascular access to give pediatric patients the necessary medications to perform rapid sequence intubation, for patients with airway difficulties.
The purpose of this study is to compare the effectiveness of two novel videolaryngoscope systems, the Glidescope and the Truview PCD against standard direct laryngoscopy (DL) in pediatric patients. The investigators primary hypothesis is that the use of videolaryngoscope devices, Glidescope and Truview provide better laryngeal views in pediatric patients as measured by Cormack and ehane (C\&L) (1 to 4, 4 the worst), without increasing the time taken to intubate (TTI), compared with direct laryngoscopy (DL). The investigators secondary hypotheses are that the use of Glidescope and Truview PCD provoke less hemodynamic response and fewer episodes of de-saturation in pediatric patients.
Children and adults frequently need a 'breathing tube' when having anesthesia for surgery. The breathing tube is usually inserted after the anesthesia doctor puts a patient to sleep with medicine, so they do not feel the breathing tube. In children, there is often a leak of air between the tube and the windpipe, as the tube is not an exact fit. Anesthesia doctors usually listen for this leak around the tube by listening to the chest with a stethoscope while gently filling the lungs with oxygen from the anesthesia machine. The leak tells them if the tube is the correct size, or too small, or too tight. If it is too small, or too tight, they usually change the tube for a better fit. The purpose of this study is to see what happens to this leak in the 30 minutes after the tube is placed. No one really knows if the leak gets bigger, smaller, or stays the same. Knowing what happens to the leak will help anesthesia doctors to decide whether to change the breathing tube or not. This is important, as a tube that is too tight can lead to breathing difficulty after removing the tube at the end of surgery, and a tube that is too small may make it difficult for the breathing machine to work effectively for the patient as a result of a large leak of air or oxygen.
This is a prospective interventional study to test the hypothesis that just-in-time training for pediatric airway management may improve patient safety and operational performance of orotracheal intubation and decreases intubation associated events in pediatric residents in the PICU. To test the hypothesis that high fidelity simulation may enhance the training efficacy and patient safety in simulation settings.
The investigators' overall objective is to assess the incidence of critical events related to tracheal intubation at all international study sites. Furthermore, the study will investigate the used intubation techniques and identify possible improvement measures to increase patient safety.
There are two routes in which a fiberoptic intubation can be performed - oral and nasal. In general, nasal intubation by any conventional method may be the preferred choice for certain procedures such as intra-oral surgeries, or for anatomical reasons such as limited mouth opening. If nasal intubation is not indicated or preferred, then oral intubation is usually performed. This study is looking to explore whether or not the nasal route significantly improves the ease and time for successful fiberoptic intubation compared to the oral route in children less than or equal to 2 years of age. This study will also examine if operator experience influence time to tracheal intubation with either route? The investigators hypothesize that the nasal route of fiberoptic intubation will be faster than the oral route, for both the trainee and the expert, and that there will be minimal differences between experts and trainees with nasal fiberoptic intubation.
This study compares the distance from the operating table to the eye of the laryngoscopist while intubating the trachea with or without a shoulder roll. A photo of the glottic opening will compare the glottic views in both positions.
This is a single center trial to evaluate the performance of the King Vision video laryngoscope in pediatric patients between the ages of one month and 10 years of age. If the performance is satisfactory, this device may become a standard laryngoscope for tracheal intubation in elective and emergent tracheal intubations.
Our study will measure the pressure of the endotracheal tube cuff in intubated patients in the emergency department.
The purpose of this research study is to compare the safety and effectiveness of three commonly used techniques for delivering anesthesia during a procedure known as esophagogastroduodenoscopy.