AnesthesiaNCT03152513
A Review of "Anesthesia Stat!" in the Pediatric Operating Room
An observational study of Anesthesia and Surgery, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Anesthesia, Surgery, Critical Illness
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 11 Sep 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Subjects under the age of 18 are included in the study only after an "Anesthesia Stat," or overhead call for help has been initiated by the provider in the room or other nursing or operating room staff involved in that patient's care. Data will only be taken when a member of the study staff is present which is typically during the week, during the typical OR day, and not the weekends or late at night.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health Pediatric Operating Room
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia, Surgery, Critical Illness, Critical Incident
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of "Anesthesia Stat" critical events
The number of new cases of "Anesthesia Stat" critical events per population at risk in the study period
Measured: 7 years
Secondary outcomes (1)
Age of patients on which "Anesthesia Stat" has been called
Median Age in months of patients on which "Anesthesia Stat" has been called.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Mar 2017
- Primary completion11 Sep 2018
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 83 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas W Templeton, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152513
- Sponsor's protocol ID
- IRB00042123
- Status last verified
- Apr 2019
- First submitted
- 8 May 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Retrospective and Prospective Review of "Anesthesia Stat!" Events in the Pediatric Operating Room
- ClinicalTrials.gov ID
- NCT03152513
- Acronym / sponsor ID
- IRB00042123
- Conditions
- Anesthesia, Surgery, Critical Illness, Critical Incident
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Subjects under the age of 18 are included in the study only after an "Anesthesia Stat," or overhead call for help has been initiated by the provider in the room or other nursing or operating room staff involved in that patient's care. Data will only be taken when a member of the study staff is present which is typically during the week, during the typical OR day, and not the weekends or late at night.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Age of patients on which "Anesthesia Stat" has been called
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas W Templeton, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Surgery, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of "Anesthesia Stat" critical events (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.