Treatment Trials

22 Clinical Trials for Various Conditions

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RECRUITING
Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)
Description

The purpose of this study is to assess the feasibility of SafeLM as a primary airway device and as a conduit for intubation with and without the use of a bougie

Conditions
COMPLETED
Supraglottic Airway Needed To Achieve Ventilation
Description

The purpose of this research is to compare if insertion of laryngeal mask airway (LMA) vs. use of face mask, will reduce the time needed to achieve adequate ventilation prior to insertion of the breathing tube.

COMPLETED
A Dual Channel Supraglottic Airway Device (LMA Gastro) for Oxygenation in Patients Undergoing ERCP
Description

This clinical trial compares the effect of LMA Gastro, a dual channel supraglottic airway (SGA) device, to oxygenation with standard nasal cannula for endoscopic retrograde cholangiopancreatography (ERCP). An ERCP is a combination of imaging scans and endoscopy that helps doctors diagnose and treat conditions of the pancreas and bile ducts that requires general anesthesia or procedural sedation. Anesthesiologists often use SGAs or nasal cannulas to help patients breathe while they are asleep during procedures. An SGA consists of an airway tube that connects to a mask, which is inserted through the mouth and placed at the back of the throat to keep the airway open while patients are under anesthesia or sedation. The nasal cannula is a device that fits in a patient's nostrils and delivers oxygen through a small, flexible tube while they are under anesthesia or sedation. The goal of this trial is to compare the effects of the LMA Gastro to nasal cannula when used to deliver oxygen to patients while they are asleep during their ERCP procedure.

RECRUITING
Structural Modification In Supraglottic Airway Device
Description

The proposed A/Z modification of a supraglottic airway (SGA) incorporates an opening in the SGA body that enables access to the endotracheal tube (ETT) through the body of the SGA without the need of using an exchange catheter, thus enabling an ETT to move in the body of the SGA and convert a supraglottic to endotracheal ventilation. In its original form an adaptor made from same material currently used in the endotracheal tubes can make ventilation through the proposed airway device possible in exactly the same manner of a conventional SGA currently used. This adapter also known as the R-piece can be replaced with an ETT. The modification also allows placement of SGA over an existing ETT to convert and endotracheal (ET) to supraglottic (SG) mode of ventilation without the need to use an exchange catheter.

COMPLETED
Comparison of Ambu Auragain and I-Gel Supraglottic Airways in Adult Patients at an Ambulatory Surgery Center
Description

The purpose of this study is to determine if an I-gel laryngeal mask airway (LMA) has a higher oropharyngeal leak pressure compared to an Ambu Auragain in adult patients in an ambulatory surgery center.

WITHDRAWN
Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation
Description

Prospective, randomized controlled trial to be performed at one center, of term and late preterm infants requiring resuscitation. Prenatal consent will be obtained. At randomization, babies will be resuscitated following Neonatal Resuscitation Program (NRP) guidelines and ventilated using the T-piece resuscitator with either a Face Mask (FM) or Non-inflating supraglottic airway. Video will be collected during resuscitation as well as written documentation. Primary outcome will be time to spontaneous breathing, length of resuscitation, and need for endotracheal intubation.

UNKNOWN
The Safety and Efficacy of Supraglottic Airway Use in Children
Description

This purpose of this study is to determine the effectiveness, risk factors, and complications associated with use of supraglottic airway devices for primary airway maintenance during routine anesthesia in children.

COMPLETED
Assessment of the I-gel and Air-Q Supraglottic Airways as Conduits for Tracheal Intubation in Children
Description

The purpose of this study is to determine if there is a difference in time for successful fiberoptic guided tracheal intubation through the i-gel or air-Q supraglottic airway.

WITHDRAWN
Use of New Supraglottic Airway Devices in Severely Obese Patients: A Feasibility Study
Description

The purpose of this study is to determine whether two new airway devices used during anesthesia called iGEL™ and KING-LTS-DTM work well and are safe in obese patients. They both work well in thin patients, but have not been tested in obese patients.

Conditions
COMPLETED
A Comparison of the Ambu AuraGain Versus LMA Supreme in Children
Description

The purpose of this study is to determine whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA) Supreme.

COMPLETED
AMBU AScope2 Fiberoptic Intubation Versus Fastrach Intubating LMA
Description

The purpose of this study is to compare two types of supraglottic airways (SGA), the Ambu® Aura-I and the Intubating Laryngeal Mask Airway (ILMA), regarding time to intubate, ease of insertion, sealing properties, optical view upon fiberoptic examination regarding the Ambu Aura-I, ease and success rate of intubation, airway morbidity, and patient comfort in patients undergoing general anesthesia for elective surgery.

WITHDRAWN
Study Comparing Intubation Via Video Laryngeal Mask Airways (VLMAs) Versus Video Laryngoscopy
Description

The goal of this clinical trial is to compare the overall performance and patient outcomes of two video-assisted laryngeal mask airways (VLMAs) devices called Safe and Comfortable (SaCo) VLM and SafeLM® (Safe VLM) versus video laryngoscopy for airway management in adult patients, without an anticipated difficult airway, that are undergoing elective general anesthesia procedures. The main question it aims to answer is: Can both VLMAs improve patient-centered outcomes in the perioperative and postoperative periods in comparison to endotracheal tube (ETT) intubation? Thirty participants will undergo randomized VLMA with either the Safe VLM (15 participants) or the SaCo VLM (15 participants). And 15 participants will be intubated with ETT using video laryngoscopy, as the control group. Researchers will evaluate the efficacy of these two video-assisted devices in adult patients without an anticipated difficult airway in elective general anesthesia procedures. Other patient outcomes and exploratory endpoints will be recorded as well.

COMPLETED
Comparison of I-gel to the Laryngeal Mask Airway
Description

The purpose of this study is to evaluate a new disposable supra-glottic airway device, the i-gel airway (Intersurgical Ltd., Wokingham, England). We propose to test its ease of insertion, position within the airway, drain tube patency and anatomic sealing properties during mechanical ventilation in non-obese anesthetized patients undergoing elective general surgery. The study device will be compared to the current standard in the industry, the LMA Unique.

COMPLETED
Clinical Comparison of the Airway Devices
Description

The purpose of this study is to evaluate a new supra-glottic airway device, the "Disposable Laryngeal Tube Suction" (LTS-D; King Systems, Noblesville, IN). We propose to test its ease of insertion, position within the airway, patency of drain tube and anatomic sealing properties during spontaneous ventilation in anesthetized patients. The study device will be compared to the ProSeal Laryngeal Mask Airway (PLMA, LMA North America Inc.) and the Esophageal Tracheal Combitube (ETC; Tyco Healthcare/Mallinckrodt Nellcor, Pleasanton, Calif).

RECRUITING
Hospital Airway Resuscitation Trial
Description

The Hospital Airway Resuscitation Trial (HART) is a cluster-randomized, pragmatic trial of advanced airway management with a strategy of first choice supraglottic airway vs. first choice endotracheal intubation during in-hospital cardiac arrest.

RECRUITING
LITES Task Order 0005 Prehospital Airway Control Trial (PACT)
Description

The Prehospital Airway Control Trial (PACT) is a proposed 5 year, open label, multi-center, stepped-wedge randomized trial comparing airway management strategies of prehospital trauma patients. The initial airway attempt will be randomized to either usual care (control) or a supraglottic airway management approach (intervention). The primary outcome will be 24 hour survival, with secondary outcomes to include survival to hospital discharge, expected clinical adverse events, airway management performance, ICU length of stay, ventilator days, incidence of ARDS, and incidence of ventilator associated pneumonia. Subjects will be enrolled across approximately 17 prehospital agencies at select LITES Network sites and will enroll a total of 2,009 subjects.

COMPLETED
Ambu AuraGain and Teleflex LMA Protector Fiberoptic Assessments in Elective Patients
Description

Participant is being asked to take part in this study because participant is going to have surgery that requires general anesthesia (in which participant is unconscious for the procedure). During surgery, anesthesiologists often place a supraglottic airway device (SGAD). An SGAD is a device that helps participant breathe and may help the anesthesiologist put a breathing tube in participant's airway while participant is asleep during surgery. There are many different kinds of SGADs that are readily available for use by anesthesiologists during surgery. The SGADs that are being studied are the Ambu Auragain and the Teleflex LMA Protector. The goal of this clinical research study is to compare the effectiveness of both devices. This is an investigational study. Both of the SGADs that are being used on this study are FDA approved and are frequently used for the surgery that participant is going to have. It is investigational to compare the 2 devices. Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions
COMPLETED
Comparison of Fiberoptic Intubation With Fiberoptic Intubation Through an Air-Q Intubating Laryngeal Airway in Infants and Small Children
Description

The goal of this prospective randomized study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The question the investigators are trying to answer is: Does the operator experience make a significant difference in the time for successful fiberoptic guided tracheal intubation with and without the use of an air-Q intubating laryngeal airway?

COMPLETED
Air-Q® SP Versus Air-Q® and I-gel: A Randomized Clinical Trial
Description

The air-Q Self-Pressurizing Intubating Laryngeal Airway (aILA SP) is a modification of the air-Q Intubating Laryngeal Airway (aILA). Besides the i-gel, it is the only breathing tube that sits above the vocal cords that does not require inflation of a cuff with air. The purpose of this study is to compare the ability of the aILA-SP to maintain patency of a patient's airway during general anesthesia with that of the aILA and i-gel devices. As a measure of this ability, we hypothesized that the airway sealing pressures will be equal between the aILA-SP and aILA, but superior when comparing the aILA-SP to the i-gel (i-gel will be lower).

Conditions
COMPLETED
A Comparison of the LMA Unique and LMA Supreme in Children
Description

The goal of this study is to compare the LMA Unique and LMA Supreme in children having surgery. We hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use, and complications (airway related, gastric insufflation, trauma) will also be assessed.

Conditions
COMPLETED
LMA Unique TM & the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children
Description

The purpose of this study is to compare the clinical efficacy of the air-Q ILA-SP with the current standard of care, the LMA Unique in anesthetized non-paralyzed pediatric patients.

Conditions
COMPLETED
Ambu® Laryngeal Mask as an Intubation Conduit
Description

The purpose of this study is to determine if the Ambu Laryngeal Mask can be used as an intubation conduit for endotracheal intubation.