- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03152513
A Review of "Anesthesia Stat!" in the Pediatric Operating Room
A Combined Retrospective and Prospective Review of "Anesthesia Stat!" Events in the Pediatric Operating Room
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Health Pediatric Operating Room
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of "Anesthesia Stat" critical events
Time Frame: 7 years
|
The number of new cases of "Anesthesia Stat" critical events per population at risk in the study period
|
7 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age of patients on which "Anesthesia Stat" has been called
Time Frame: 7 years
|
Median Age in months of patients on which "Anesthesia Stat" has been called.
|
7 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00042123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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