Treatment Trials

87 Clinical Trials for Various Conditions

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COMPLETED
Just-In-Time Rapid Cycle Deliberate Practice Simulation Intubation Training Among Novice Pediatric Anesthesia Trainees: A Randomized Control Study
Description

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.

Conditions
COMPLETED
Society for Pediatric Anesthesia Improvement Network- Anterior Cruciate Ligament Reconstruction Outcomes Project
Description

The primary objective is to create a multicenter registry which captures information relating to the perioperative anesthesia course and management of children undergoing anterior cruciate ligament reconstruction and to examine practice patterns and incidence of complications. Data from any single institution involved in this registry will be used for local safety and quality improvement efforts. In addition data from each institution can be compared to the information from the entire group of institutions participating in the project, thus providing a measure for comparison with national practice. The aggregate multi-institutional data set will be used to develop quality benchmarks for national safety and quality improvement efforts and best practice recommendation. We believe that this registry can also demonstrate how web based data collection can be used to evaluate clinical anesthesia outcomes for surgeries with a low incidence of critical events but with significant variability in medical management.

COMPLETED
Perioperative Virtual Reality for Pediatric Anesthesia
Description

The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial.

Conditions
COMPLETED
Methadone in Pediatric Anesthesia
Description

This study will determine the pharmacokinetics of intravenous (IV) methadone in children undergoing surgery.

Conditions
COMPLETED
PANDA (Pediatric Anesthesia & NeuroDevelopment Assessment) Study
Description

The purpose of this study is to determine whether the use of anesthetic agents in infants and children have long term adverse effects on neurocognitive development. According to the National Hospital Discharge Survey, around 2.5 million children have surgical procedures requiring anesthesia each year in the US. Recent animal studies have suggested that the exposure of the immature organism to a variety of commonly used anesthetic agents may lead to neurobehavioral functional deficits in vivo and to neuronal apoptosis in vitro. While the relevance of these findings on children exposed to anesthetics remains to be determined, it is clearly critically important to public health that this issue is resolved quickly and clearly. Hypothesis: Exposure to anesthetic agents within the first three years of life will not significantly impair cognitive functions at ages 8 yr, 0 mo to 15 yr, 0 mo.

RECRUITING
The Pediatric Anesthesia Quality Improvement Project
Description

The Study is designed to collect information about adverse events that occur in children undergoing anesthesia in participating hospitals. Demographic information will be collected on all anesthetics. An analysis of each adverse event will be performed and entered into the database. From this information we will devise strategies to prevent these adverse events.

RECRUITING
Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane
Description

The purpose of this protocol is to determine the effect of two clinically applicable Dexmedetomidine dosages (0.5mcg/kg and 1mcg/kg) on the minimum alveolar concentration (MAC) of Sevoflurane in children between the age ranges of: 1-6 months; 6-12 months of age and 12 months-36 months years of age.

COMPLETED
King Vision Video Laryngoscope Ambu (aBlade) System for Use in Children
Description

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.

COMPLETED
Multi-center Isoelectric EEG Study in Children Under General Anesthesia
Description

Multi-center, prospective, observational study investigating the incidence of isoelectric electroencephalography (EEG) events and the associated peri-operative factors in infants 0-3yo undergoing general anesthesia.

COMPLETED
Evaluation of Multiscore Feedback in Professionalism for Anesthesia
Description

Professionalism is one of the six competences required by The Accreditation for Graduate Medical Education Outcome Project to be taught and evaluated during residency. Anesthesia residents are faced with unique communication challenges in their practice including brief contact time with their patients, operating room efficiency pressure, etc. To assess professionalism in Anesthesiology residents is important to obtain evaluations from people with whom they interact including patients, surgeons, colleagues and members of the support team. The Multisource feedback (MSF) approach has been used to evaluate communication skills and professionalism among practicing physicians and residents in a variety of settings. This evaluation model has never been used previously to evaluate anesthesia residents. The investigators propose a randomized controlled trial to validate and evaluate a MSF in professionalism for anesthesia residents. Participants include eighty residents doing two months rotation in Pediatric Anesthesia Department at The Cleveland Clinic Anesthesia Institute from July 1, 2011 and June 30, 2013. MSF questionnaires will be validated using face and content validity methods and comparing them with the current system of evaluation. Residents will be randomly assigned to a feedback group or to the control group. Both groups will receive MSF evaluation from the faculty, patients' parent and coworker. Only the group assigned to feedback is going to have a 'coaching meeting' every month to identify strengths and weaknesses and create strategies for improvement. The investigators are planning to compare the mean values of the baseline evaluations with the mean values obtained after the first and second months from the MSF.

RECRUITING
Decreasing Emergence Delirium With Personalized Music
Description

This is a prospective randomized controlled trial in children 3-9 years of age undergoing myringotomies at Washington University in St. Louis to assess the impact of perioperative personalized music on the incidence of emergence agitation.

COMPLETED
Use of an Adaptive Sensory Environment in Autism Spectrum Disorder (ASD) Patients in the Perioperative Environment
Description

The objective of this study is to prospectively examine the preoperative anxiety scores of ASD patients in an adaptive sensory environment. Additionally, the investigators aim to determine the relationship of severity of sensory integration in ASD patients and their preoperative anxiety scores. The study will also study the family satisfaction with tailored care of their ASD child in the peri-operative environment.

COMPLETED
Preparing Children for Anesthesia With an Educational Pop-Up Book
Description

The study evaluated an educational pop-up book about general anesthesia induction as an interactive, child-focused preoperative education resource for pediatric patients undergoing outpatient surgery. The study's objectives were to evaluate the book as an educational tool and to understand the book's effects on patient and caregiver perceptions of the surgical experience. The study's hypotheses were that preoperative education from the pop-up book, compared to standard care, would more effectively reduce children's fear and expected pain, facilitate more positive views of the procedure and preoperative explanations, encourage adaptive coping strategies, reduce behavioral anxiety at anesthesia induction, and increase caregiver satisfaction with the surgical experience.

COMPLETED
Defining the 'Sniffing Position" in Infants and Toddlers - A Pilot Study
Description

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.

RECRUITING
Evaluation of Extubation Criteria in Children With Upper Respiratory Infection (URI)
Description

The investigators are currently completing a data collection to try to optimize pediatric patients' preoperative screening, in the setting of an upper respiratory infection.

WITHDRAWN
Articaine vs Lidocaine for Pediatric Dental Procedures
Description

The purpose of this study is to compare the efficacy of two types of local anesthesia (articaine and lidocaine) for infiltration anesthesia during restorative dental procedures on lower teeth in pediatric patients. The patients will require similar dental operative procedures on both right and left sides of the mandible in order to qualify for this study. The study will require at least two dental appointments, where a randomized, cross-over study methodology will be utilized. All subjects will be treated by the same dentist. The comfort of the patient will be assessed at various points during the procedure using the Wong-Baker Faces Scale.

UNKNOWN
Supraclavicular Blocks for Post-Operative Pain Control in Supracondylar Fracture Fixation, a Retrospective Analysis of Single Shot Catheter Techniques
Description

We hypothesize that patients who receive a supraclavicular block via Angiocath, placed intra-operatively and dosed post-operatively following neurologic examination, will have lower pain scores, lower use of intravenous morphine equivalents in the post-anesthesia care unit, and lower rates of intervention for post-operative nausea and vomiting. We also hypothesize that patients receiving this nerve block had the same rates of nerve damage as the patients who did not receive a block and that there will be no demonstrable safety concerns with this block.

COMPLETED
CARE--Childhood Awareness and Recall Evaluation
Description

The purpose of this study is to describe the incidence of recall or awareness under anesthesia in children aged 5-15 by collecting anesthetic and post-operative follow-up data relating to intra-operative recall during general anesthesia. The hypothesis is that the implementation of routine awareness follow-up evaluation in children undergoing general anesthesia will identify that the incidence of intra-operative awareness in children is equal to or greater than in adults.

Conditions
COMPLETED
Extubation in Pediatric Patients: An Observational Study
Description

The timing of extubation following surgery and anesthesia in young children is a complex decision frequently guided by the experience of the clinician. The clinician frequently must make a decision based on assimilating multiple cues that may or may not demonstrate that the patient is ready for extubation such as eye opening, conjugate gaze, spontaneous ventilation, and end tidal agent concentration. At this time there is no published data on the predictive ability of individual extubation criteria for young patients undergoing anesthesia for surgery so most practice is based solely on experience and anecdotal teaching. In some cases if the timing is misjudged and the patient is extubated too early negative airway reflexes such as breath holding and laryngospasm may take over creating a critical situation in which the patient forgoes gas exchange and rapidly desaturates with the potential for bradycardia and further cardiovascular collapse. Routine criteria used to determine fitness for extubation have been primarily described in the intensive care unit literature and may be less relevant in the operating room in the setting of routine general anesthetics. Most predictors including adequate tidal volume, presence of conjugate gaze, eye opening, patient movement purposeful or otherwise, low end tidal anesthetic agent concentration, response to physical or verbal stimulation and the laryngeal stimulation test have not previously been evaluated to determine their individual predictive value in deciding if the presently anesthetized patient now emerging is ready to be extubated. In order to perform a laryngeal stimulation test the patient must be breathing spontaneously and practitioner will gently move the endotracheal tube up and down stimulating the larynx. In patients in stage 2 of anesthesia, the clinician will typically observe a cough or series of coughs followed by a respiratory pause of greater than 5 seconds. In this situation the patient has not adequately passed through stage 2 and remains at increased risk for apnea, breath holding, or laryngospasm. If the patient is in stage 1 of anesthesia the clinician will observe a cough followed by a brief pause (less than 5 seconds) or almost immediate return to spontaneous ventilation. In conclusion, their exist no quantitative data on the predictive value of these various criteria for extubation and the goal of our study is determine the indivdual predictive value of different criteria in determing fitness for extubaion in young pediatric patients by recording the presence or absence of various criteria in pediatric patients at the time of extubation during routine anesthetic care.

RECRUITING
The Efficacy of Biplane Versus Single Plane Ultrasound in Facilitating Caudal Epidural Anesthesia in Pediatric Patients.
Description

Ultrasound guidance plays a pivotal role in caudal epidural block in pediatric patients. In comparison to conventional single-plane ultrasound, biplane ultrasound offers the advantage of providing simultaneous transverse and longitudinal imaging. Better visualization under biplane ultrasound is postulated to enhance the efficacy of caudal epidural blocks. This improvement is expected to manifest through higher first puncture success rate, shorter procedure time, and longer time to first postoperative analgesics use.

COMPLETED
Regional Anesthesia Following Pediatric Cardiac Surgery
Description

The purpose of this study is to evaluate pain control following pediatric cardiac surgery with the use of local anesthesia via an ultrasound guided regional anesthetic technique compared with surgeon delivered wound infiltration.

RECRUITING
Regional Anesthesia in Pediatric Orthopaedic Patients
Description

To identify the benefits from regional anesthesia use as pain management in the pediatric population by delineating the differences in efficacy of continuous nerve blockade versus single-shot techniques after pediatric orthopaedic limb procedures. By doing this, the investigators can determine if specific anesthetic techniques should become a standard of care in pain management for the pediatric population and supersede the need for opioid medication.

COMPLETED
Effects of Anesthesia on Pediatric Surgical Patients With a History of Concussion - Phase I
Description

The purpose of this research study is to determine the number of children who have symptoms of a concussion at the time they are scheduled for orthopedic surgery at Boston Children's Hospital. It is currently unknown if anesthesia affects a child with a previously diagnosed concussion. This study is the first phase of a two-part study looking at the effects of anesthesia in children undergoing orthopedic surgery with a previous concussion. Currently, the decision to continue with surgery in patients with a diagnosed concussion is based on clinical judgment by the patients.

COMPLETED
Temperature Changes During Induction of General Anesthesia in Pediatric Patients
Description

We aim that uncovering patients during induction of general anesthesia does not decrease core body temperature in pediatric patients.

Conditions
RECRUITING
Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery
Description

This is a prospective, randomized, controlled, non-inferiority study of patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. The overall aim is to evaluate the efficacy of an opioid anesthetic plan (morphine, ketorolac, and acetaminophen versus an opioid sparing anesthetic plan (dexmedetomidine, ketorolac and acetaminophen) for perioperative analgesia and recovery time in patients undergoing tonsillectomies and tonsillotomies at Boston Children's Hospital Waltham. Secondary measures include rescue opioids administered in post-anesthesia care unit (PACU), re-operation secondary to bleeding, emergence delirium, post-operative nausea and vomiting, intraoperative hemodynamics, intraoperative vasopressor administration, and length of procedure.

RECRUITING
Total Intravenous Anesthesia (TIVA)/Sevoflurane Initiated Intravenous Anesthesia (SIIVA) in Pediatric Patients
Description

Because Propofol is the primary "anesthetic agent," and inhalational agents remain in trace quantities at the end of the procedure Sevoflurane initiated intravenous anesthesia (SIIVA) or not present at all Total intravenous anesthesia (TIVA) it is likely that different criteria may be predictive of extubation success in these patients compared to inhalational anesthesia.

Conditions
ACTIVE_NOT_RECRUITING
AVATAR Anesthesia Alternative in Pediatric Radiotherapy: A Multi-Center Study
Description

To determine the success rate of the AVATAR audio-visual system. All patients enrolled in the study will be counted, and each patient who is able to undergo at least one fraction without anesthesia will count as a success while each patient who does not have at least one fraction without anesthesia will count as a failure. The success rate will be the proportion of patients who are successes.

Conditions
TERMINATED
SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation
Description

The purpose of the study is to collect EEG data with the Masimo SedLine device along with vital signs, patient demographics, anesthetic record and surgical procedure during general anesthesia or sedation.

Conditions
COMPLETED
The Evaluation of a Noninvasive Respiratory Monitor in Pediatric Patients Undergoing General Anesthesia
Description

Pediatric postoperative patients are at increased risk for post-operative respiratory complications such as hypoventilation. There is no objective measure of early respiratory parameters that would predict respiratory compromise after surgery efficiently in pediatric patients. Current respiratory assessment in non-intubated patients relies on oximetry data, impendence respiratory rate monitor and subjective clinical assessment. Pulse oximetry has been extremely helpful in recognizing oxygen desaturations but it is a late indicator of respiratory decline. New advances in technology and digital signal processing have led to the development of an improved impedance based Respiratory Volume Monitor (RVM). The RVM (ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) has been shown to provide accurate real-time, continuous, non-invasive measurements of tidal volume (TV), minute ventilation (MV) and respiratory rate (RR) mostly in adult patients. The investigators' primary hypothesis is that the non-invasive, impedance-based RVM monitor will accurately reflect TV, RR and MV in pediatric patients.

COMPLETED
Effect of Dexmedetomidine on QT Interval in Pediatric Patients Under General Anesthesia
Description

Various medications used in anesthesia have been implicated in the prolongation of QT interval. Recently, there has been an increase in the use of dexmedetomidine in patients presenting for surgeries given its beneficial sedative, anxiolytic, and analgesic properties. It has several desirable properties including minimal respiratory side effects as well as the ability to decrease intraoperative and postoperative analgesic requirements. In many of the patients who present for routine surgical procedures, dexmedetomidine is a common component of their anesthetic care. This is a study to assess the effects of dexmedetomidine on the QT interval in children presenting for surgery.

Conditions