Request for Funding
Medical Student Research Fellowship for Summer 2004
Mentor: Lynn Roppolo, MD
Department: Surgery, Division of Emergency Medicine
Room number: CS2.122
Mail Code: 8579
Phone number: 214-648-9584
E-mail: lynn.roppolo@utsouthwestern.edu
Two Projects
Project I title: A Prospective Study of Comparing Standard Laryngoscopy to the TrachView Fiberoptic Intubation System during Endotracheal Intubation
Human subjects IRB approved project number (where applicable): IRB1203-802, approval pending.
Animal subjects IRB approved project number (where applicable): N/A.
Project Type: Patient-based
Brief Description of Project:
This study is designed to compare the Percentage Of Glottic Opening (POGO) score observed during direct laryngoscopy to that observed on the Trachview Videoscope. Two different populations of subjects will be studied in each phase of the study as described below.
1. Phase I - Adult patients requiring endotracheal intubation for elective
surgery at Zale Lipshy for Parkland Hospital will be enrolled. Informed consent
will be obtained on all patients prior to the administration of sedative medications
or anaesthetic agents. Intubation will be performed by faculty or senior residents
from the Department of Anesthesia.
2. Phase II - This phase of the study will begin after completion of phase I
has revealed a favorable outcome and no complications attributed to the TrachView
Videoscope system. Adult patients requiring endotracheal intubation in the Emergency
Department at Parkland Hospital. Informed consent will be waived as patients
intubated in the Emergency Department are performed on an emergent basis for
life-threatening emergencies. Intubation will be performed by Emergency Medicine
faculty or senior residents.
Protocol:
1. The physicians who will perform TrachView-assisted intubation will attend
a 20 minute training session. During this time, the study protocol will be discussed,
the Trachview Videoscope system will be reviewed, and each physician will successfully
intubate a mannequin 3 times using this system.
2. All patients meeting inclusion criteria will be enrolled. Informed consent
will be obtained on Phase I study subjects only.
3. The physician managing the airway will perform direct laryngoscopy and assess
the percentage of glottic opening visualized and then introduce the endotracheal
tube into the posterior oropharynx as per the current standard of care.
4. However, the endotracheal tube will be equipped with the TrachView Videoscope
in which a narrow fiberoptic scope will be inserted by an assistant into the
lumen of the endotracheal tube as mentioned above.
5. The physician performing the intubation will then assess the amount of glottic
opening visualized with the TrachView Videoscope.
6. Finally, the patient will be intubated. The decision to pass the tracheal
tube through the vocal cords by direct laryngoscopy or with the assistance of
the TrachView Videoscope will be at the discretion of the individual intubator.
7. After the intubation is complete, the physician managing the airway will
complete the data collection sheet which includes documentation of the percentage
of glottic opening (POGO) score based upon direct observation with standard
laryngoscopy and then with the use of the TrachView Videoscope. The POGO measurement
scale of 0, 25%, 50%, 75%, and 100% (percent of glottic opening viewed by each
of these methods) will be used.
Student's Role: The student will be assisting with Phase I of this study and
will have the following responsibilities:
1. Obtain informed written consent on all patients enrolled in Phase I of the
study.
2. Assist the anesthesiologist with operation of the TrachView equipment.
3. Assist with maintaining the TrachView equipment.
4. Assist with data collection.
Project II title: Databank of patients with possible acute coronary syndromes: Characteristics, demographics, and serum (PI: Dr. Kurt Kleinschmidt)
Human subjects IRB approved project number (where applicable): Submitted
Animal subjects IRB approved project number (where applicable): N/A.
Project Type: Patient-based
Brief Description of Project: The purpose of the project is to establish a databank of patient characteristics, demographic information, and blood serum that can be applied to soon to be established cardiac makers. The new marker outcomes would be compared with the current Parkland Memorial Hospital standard of care for the assessment of patients who present to the emergency department with chest pain.
Eligible patients, those with a "possible" acute coronary syndrome (ACS), will receive the current standard of care assessment as dictated by the Parkland Chest Pain Protocol. This includes the arrival EKG and the nine-hour EKG; troponin I done upon arrival, at three hours, at six hours, and at nine hours; and continuous telemetry monitoring. In accordance with the standard, a saline lock is established upon patient arrival and blood draws are done via the saline lock.
Patients entered into the trial will have the standard blood draws done at times zero, three hours, six hours, and nine hours. A bedside cardiac marker test, known as the Triage Cardio ProfilER, will be performed and compared to laboratory findings. Patient care and dispositions will be based on the current standard of care and not based upon the Triage Cardio ProfilER results .
Study patients will have one extra tube of blood (a red top; ~ 5 mL) obtained with each blood draw. Study patients will also have a 90-minute blood draw done. The 90 minute blood draw would also be obtained via the saline lock. Study tubes will be labeled with a specific study ID number and time of draw. Study tubes will be standard serum separating red top tubes. A member of the research team will centrifuge the tubes and separate the serum into smaller aliquots. The aliquots would be frozen.
At the time of the initial evaluation in the ED, a member of the research team will complete an initial evaluation case report form. It is a one-page form with check-box answers.
Follow-up of patients entered into the study will be accomplished by various methods. All study patients will receive a 30 day follow-up telephone call to learn how the patient has done, if any risk stratification tests were done, if any follow-up health visits or hospitalizations have occurred. If a patient was re-evaluated within the Parkland Health and Hospital System, the OACIS Data Repository System will be assessed for details. A follow-up case report form will be used for this data.
Students participating in this study will be assisting with data collection by conducting the surveys, performing the bedside cardiac marker tests, maintaining the database, and will process the extra tube of blood that will be stored for future cardiac marker studies.
Previous Research Activities or Publications with Medical Students:
1) Benjamin Hatten - "The Utility of Ultrasound in the Diagnosis and Treatment of Superficial Abscesses." This study is ongoing. The initial study that was done during the summer of 2003 was a pilot study. The protocol was modified and we currently have 30 patients enrolled. We hope to put together an abstract for submission by the summer of 2004.
2) Mandi Holland - "Determining the Accuracy of Cardiac Arrest Detection
by Emergency Medical Dispatchers: Can Agonal Breathing Detection Make a Difference?"
This is a before and after study. Data has been collected since March of 2003.
We instituted a new dispatcher protocol in November 2003 and are collecting
data to determine if there is any improvement in cardiac arrest detection by
dispatchers since the implementation. We have approximately 500 subjects enrolled
at this time and hope to put together an abstract by the summer of 2004.
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