NCT03152513

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2018

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

May 8, 2017

Last Update Submit

April 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    7 years

Secondary Outcomes (1)

  • Age of patients on which "Anesthesia Stat" has been called

    7 years

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Health Pediatric Operating Room

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas W Templeton, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 15, 2017

Study Start

March 1, 2017

Primary Completion

September 11, 2018

Study Completion

September 11, 2018

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations