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Utility of the End-Tidal Monitor:
Data Sheet, Data Collection Tips, Study Flow, FAQs
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Overview:
A study designed to determine if
End-Tidal monitoring lowers the rate of hypoxic events during emergency
department procedural sedation and analgesia. Randomization will be
either the doctor able to view the end-tidal monitor, or to be "blinded"
to it.
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Study Endpoints:
1. Respiratory depression as assessed by ETCO2 2. Mental status as
assessed by OAAS 3. Pulse oxygen, pulse,
and blood pressure monitoring |
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Eligible Patients:
Adult (≥18 y.o.) patients undergoing a procedural sedation for any
reason.
This study must only
be used with patients receiving Propofol, and can therefore be combined with other
sedation studies we are currently conducting. Studies which can be
combined are: Capnography study and Propofol v. Ketamine (if patient
randomizes to Propofol).
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Study Design:
Prospective, randomized clinical trial.
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Anticipated
Benefits: ETCO2 monitoring mandated by the study may improve safety
of procedure.
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Potential Risks:
The usual risks associated with procedural sedation.
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Research Associate’s
Role: The RA is responsible for identifying, enrolling, and
collecting data from eligible patients for this study. The RA is in
charge of setting up and putting away the End-Tidal CO2
monitor used to obtain data during the procedure. Depending on what is
randomized, the doctor may or may not be also looking at the End-Tidal
monitor during the procedure. After the study, the
RA conducts interviews of the physician and the patient. Note - BIS
Monitor will not be used for this study!!
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Physician’s Role:
The RA will ask you to notify them of any conscious sedations being
performed so that they may enter the patient into the study. You
will be asked to perform the sedation either looking at or blinded to
the End-Tidal monitor. Once
the procedure is over, you will be asked to complete a short
questionnaire about the success of the procedure and the time it took
for the patient to return to baseline mental status.
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Location of Study
Packets: Team Center B
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