|
|
|
|
Research Activity 2009 - 2010
Current Clinical Research
The ResQ Trial
This 3-arm, NIH-funded, multi-center, randomized, out-of-hospital clinical trial is examining the safety and efficacy of 2 investigational devices used during cardiopulmonary resuscitation (CPR). The three treatment arms include: standard CPR (S-CPR), S-CPR with an impedance threshold device (ITD), and active compression decompression CPR with an ITD. The study began in 2005 and will run through the end of 2009. St. Paul Fire and Safety Services is the sole agency enrolling patients under an exemption from informed consent for emergency research (CFR 50.24). The primary endpoint is hospital discharge, with several secondary endpoints, including return of spontaneous circulation (ROSC), and 24 hr. survival.
- EMS Research Team
- Principal Investigator: RJ Frascone, MD
- Study Coordinator: Sandi Wewerka, MPH
- Study Staff: Josh Salzman, MA; Kent Griffith, RN/EMT-P; Joe Jensen, RN/ EMT-P; David Hodgson, EMT-P; Karen Manor, RN; Dede Koenekamp, RN; Gayle Chapman, RN; Jennifer Smith, EMT-I
- Study Sponsor
- Advanced Circulatory Systems, Inc.
- Study Funding
- National Heart, Lung, and Blood Institute
- Local Firefighters 21
- Guidant Foundation
- HealthPartners Research Foundation
- Metropolitan Emergency Services Board
Medication Assisted Airway Management with the King LTS-D Airway
This 10-patient pilot study is examining prehospital provider use of the King LTS-D airway as a primary airway in patients who require rapid sequence induction (RSI). The primary endpoint is successful insertion (defined as ventilation to chest rise and confirmation by ETCO2 readings), with secondary endpoints relating to speed of insertion and provider evaluation of the device. Lakeview EMS (Stillwater, MN) is the sole agency enrolling patients into this trial. The study began in May of 2007 and is anticipated to conclude by May of 2008.
- EMS Research Team
- Principal Investigator: RJ Frascone, MD
- Co-investigators: Josh Salzman, MA; Kent Griffith, RN/EMT-P; Kory Kaye, MD; Joe Jensen, RN/EMT-P
- Study Coordinator: Sandi Wewerka, MPH
- Study Funding
- Metropolitan Emergency Service Board
EMS Provider Use of the Pediatric EZ-IO Needle in Pediatric Patients: A Pilot Study
This study is examining prehospital provider use of the pediatric EZ-IO needle set. The primary endpoint is successful insertion (defined by insertion into the tibia and free fluid flow), with secondary endpoints including time to insertion and provider comfort measures. Two hundred forty-six EMS providers (EMT-P and RNs) from 14 EMS services in Minnesota and western Wisconsin were trained in the use of the device. This study began in May of 2006 and data collection will be complete in December of 2007.
- EMS Research Team
- Principal Investigator: R.J. Frascone, MD
- Co-investigators: Josh Salzman, MA; Joe Jensen, RN/EMT-P; Sandi Wewerka, MPH
Intraosseous Blood Values Compared to Peripheral Venous Blood Values during S-CPR and S-CPR with an ITD in a Porcine Model
The purpose of this porcine laboratory study is to determine the consistency and reliability of blood values from intraosseous blood to peripheral blood samples. The pilot data from this study will be used to support a human trial examining intraosseous vs. peripheral blood, as the use of intraosseous access in the prehospital setting is increasing. The following values are under investigation: glucose, BUN, sodium, potassium, chloride, hematocrit, hemoglobin, blood pH, pCO2, and HCO3. Animal laboratory facilities at Hennepin County Medical Center are being used for this study.
- EMS Research Team
- Principal Investigator: RJ Frascone, MD
- Co-investigators: Josh Salzman, MA; Sandi Wewerka, MPH; Duncan McBean, MD; Scott McKnite, PhD
Development of an Intramedullary Pressure Coefficient in a Porcine Model
The purpose of this study is to determine if a pressure coefficient exists between intramedullary pressure and aortic pressure in a porcine model. This pilot data will be used for potential future human trials to determine the benefit of central pressure monitoring in critical patients if an intraosseous pressure coefficient can be developed. Animal laboratory facilities at Hennepin County Medical Center are being used for this study.
- EMS Research Team
- Principal Investigator: RJ Frascone, MD
- Co-investigators: Josh Salzman, MA; Sandi Wewerka, MPH; Scott McKnite, PhD
Use of the BIS Monitor for in the Helicopter: A Feasibility Study
This air medical study is evaluating the feasibility of and comfort with the use of bispectral index monitoring (BIS) in chemically paralyzed patients. This device is used to assess level of consciousness and the need for further paralytic agents. LifeLink III is the sole agency enrolling patients into this trial.
- EMS Research Team
- Principal Investigator: Ryan Fringer, MD
- Co-investigators: William Heegaard, MD; Greg Pippert, MD; R.J. Frascone, MD; David Dries, MD
Interior Isolette Noise in Rotor-Wing Air Medical Transport
This descriptive pilot study is examining the decibel and frequency levels within an isolette during air medical transport of neonatal infants. This study is supported by funding from the Foundation for Air-Medical Research and Education, the funding organization of the Association of Air Medical Services. This study was started in January of 2007 and will finish data collection in December 2007. The rotor-wing division of LifeLink III is the sole agency collecting data for this study.
- EMS Research Team
- Principal Investigator: Greg Pippert, MD
- Co-investigators: Josh Salzman, MA; William Heegaard, MD; RJ Frascone, MD.
AART (Advanced Airway Research Trial)
This study is a multi-center, randomized, consecutive patient pre-hospital clinical trial examining EMS provider use of the King LTS-D airway versus the standard of care (endotracheal intubation). There is an ongoing debate in EMS surrounding appropriate advanced airway management for patients. In addition to proper initial and continued training with proper medical direction oversight, the type of airway device providers use is a variable that has not been extensively studied. The current gold standard is the use of an endotracheal tube. The success rate with this procedure in the pre-hospital setting is highly variable and dependent on the patient population. The King LTS-D is an FDA-approved advanced airway device that is placed into the patient's esophagus. The patient is ventilated through holes in the tube that align with the entrance to the patient's windpipe. To date, there are no clinical trials examining the effectiveness of this device. There appear to be advantages to use of the King LTS-D over ETI, and this study will be the first study in the nation to compare endotracheal intubation and King airway in a clinical trial. EMS agencies who receive medical direction from Regions EMS, Allina Medical Transportation, and Mayo Medical Transportation will participate in the study. The primary endpoint is a comparison of the rate of successful insertions between the two devices. Secondary endpoints include time to first ventilation through the devices and the rate of adverse events. Because this is a study of EMS provider performance with the device, the EMS provider will be considered the study subject and will be going through the consent process prior to participation.
AART-HEMS (Advanced Airway Research Trial Helicopter EMS)
The primary goal of this study is to compare air medical provider first attempt success rates with the King LTS-D as the primary airway to historical ETI controls. Successful insertion will be defined as meeting the 4 following criteria: ability to ventilate to chest rise, absence of gastric sounds, presence of bilateral lung sounds, and tube placement confirmed with qualitative end-tidal CO2 readings. Secondary aims include 2nd attempt and overall success rate, the evaluation of time to insertion of the device (time from package open to first successful ventilation), pre- and post-oxygen saturation data, end tidal carbon dioxide measurement at 2 mintues post insertion, and complications while using the King LTS-D as the primary airway. The impact of this study will be significant, as it will be the first report of King LTS-D use in air medical transportation. The ultimate goal of this research is to give air medical providers options for advanced airway management that may aid in better patient care for critically ill and injured individuals. A broader implication may be the use of the King LTS-D for RSI in ground EMS crews configured with paramedic/EMT-B.
Manuscripts Under Editorial/Peer Review
Regions Hospital EMS Bibliography
|
|
|
|
|
|
|
|
