A Review of "Anesthesia Stat!" in the Pediatric Operating Room



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any - 17
Updated:11/8/2017
Start Date:March 1, 2017
End Date:April 2018
Contact:Thomas Templeton, MD
Email:ttemplet@wakehealth.edu
Phone:(336) 716-4285

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A Combined Retrospective and Prospective Review of "Anesthesia Stat!" Events in the Pediatric Operating Room

The objective of this study is to look at critical events in the pediatric operating room in
a retrospective and now prospective fashion to determine if there are any trends such as age,
presence of URI, type of surgery, type of airway, level of hands on provider, or other
predictive markers associated these events so that we may gain some insight into perhaps
reducing the incidence of these events or simply be more attune to the increased risks in
certain situations.

The goal of this study is to further characterize these events, determine the incidence in
the operating room, unmask associated issues to improve vigilance, and to look and see if
there are possibly improvements to be made in the investigators care of all pediatric
patients to further reduce the incidence or sequelae of these events.

Also, the investigators want to characterize the details associated with these events. Do
these patients have prolonged PACU stays? How long are these events? Are they mostly
respiratory in nature? What is the average level of desaturation when it occurs. Is it
primarily at the beginning, middle, or end of procedures.

This study will have a two pronged approach as the investigators have been collecting
prospective observational data already for the QI project looking at this issue using the
data sheet in Appendix 1. The investigators have been collecting this data since April of
2015 to the present. This data needs to be entered into a data base so that it can be
analyzed in greater detail.

In addition to reviewing the data we have already obtained we would like to begin to collect
data prospectively to add to the data we have already collected. Patients that have already
been collected will assigned a study number based on the chronology of their event will older
event receiving a smaller study ID number and more recent patient receiving a higher study
number. This same sequence will continue into our prospective data base.

Going forward, the investigators will continue the current methodology of having study
personnel who are present in the pediatric operating room respond to stat calls within the
pediatric OR or other pediatric anesthetizing site. The study personnel will assist the
practioner or practioners already present first, and when possible will collect data related
to the event in real time or immediately afterward and enter that on the study data form.

The investigators will record basic demographic data about the patient including age, weight,
height, presence of URI or Asthma, procedure, surgeon. The investigators will record the time
of the event, duration, significant changes in vital signs, practitioners opinion of
causality if possible, and any therapeutic steps that were instituted such as the
administration of other medications, assistance with breathing, administration of oxygen,
reintubation. This will be documented in the narrative section of the data sheet.

These data sheets will then have most data entered on them into a deidentified spread sheet.
A linkage file will be created so that a patient's study ID can be linked to their actual
medical record number in case other information would be necessary or helpful in further
evaluating the "Anesthesia Stat," event already noted.

Study personnel will also review the narratives of these cases to determine if there are any
common patterns that may not be readily apparent with simple numerical and case data entered
into the database.

Inclusion Criteria:

- Patients <18 years of age

- Patients undergoing anesthesia and/or surgery or a diagnostic procedure in the
operating room or other anesthetizing sites for which a stat page for help has been
initiated.

Exclusion Criteria:

- Patients >=18 years of age.

- Patients having a critical event not under anesthesia in other venues within Brenner's
Children's hospital or within the pediatric intensive care unit.
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Phone: 335-575-5712
?
mi
from
Winston-Salem, NC
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