Intentional Blindness During Perioperative Cardiac Arrest

March 23, 2020 updated by: Express Collaborative

Patterns of Inattentional Blindness During Perioperative Cardiac Arrest: Do Healthcare Providers See and Correct Critical Errors?

Cardiac arrest in the operating room is a rare but potentially catastrophic event with mortality rates greater than 50%. Recent CPR guidelines published by the American Heart Association (AHA) and the Heart and Stroke Foundation of Canada (HSFC) describe how high quality CPR improves survival rates and neurological outcomes from cardiac arrest. Despite CPR training, adherence rates with performance guidelines are alarmingly low in many pediatric hospitals . In addition to performance errors, medication errors have been reported to be as high as 50% during cardiopulmonary arrest. This can be attributed to many factors, including distractions and poor communication among team members. Previous studies suggested that loud noise in the operating room caused poor communication and impaired surgical performance. To understand more about simulation awareness during peri-operative cardiac arrest, the investigators are planning on conducting a prospective observational study, using a simulated perioperative cardiac arrest scenario in pediatric hospital.The investigators are aiming for a convenient sample of 20 simulation sessions. Each session will have a team of CPR providers (2 participants and 4 confederates). The 2 participants will include one anesthesiologist and one operating room nurse. The participants will be randomized into two group; group A will work in a noise environment of 85 dBA ( as per recommendation by the National Institute for Occupational Safety and Health (NIOSH), and group B will work in a noise environment of 100 dBA. Participants will be wearing eye tracking devices during the scenario (Tobii Pro GlassesTM) designed to capture areas of interest (AOI) / visual fixation. The investigators hypothesize that CC and medication errors are frequently left undetected and uncorrected, and that the less noise distractions during resuscitation improves but does not eliminate this pattern of inattentional blindness in resuscitation teams during simulated perioperative pediatric cardiac arrest. They also hypothesize that "look but not act" events are a frequent occurrence during simulated pediatric cardiac arrest, and that healthcare providers will have varying reasons that explain the occurrence of "look but not act" events.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Pediatric Cardiac Arrest and intraoperative arrest Cardiac arrest in the operating room is a rare but potentially catastrophic event with mortality rate of more than 50% . Each year, it is estimated that >15,000 infants and children in North America receive cardiopulmonary resuscitation (CPR) as a treatment of cardiopulmonary arrest (CPA). The incidence of pediatric perioperative cardiac arrest can be as high as 20.9 per 10,000 cases. Recent CPR guidelines published by the American Heart Association (AHA) and the Heart and Stroke Foundation of Canada (HSFC) describe how high quality chest compressions (CC) with adequate compression depth (5-6 cm) and rate (100-120 beats/min) improves survival rates and neurological outcomes from CPA. Patients receiving CC with adequate depth are more likely to survive than those who aren't (70% vs 16% 24-hour survival), while those receiving CC within the target rate range demonstrate the highest rates of survival.

Despite CPR training, adherence rates with performance guidelines are alarmingly low at pediatric hospitals. Professional rescuers observed that CPR quality during simulated and real cardiac arrests frequently fall well short of guidelines in leading institutions. In addition to performance errors, medication errors have been reported to be as high as 50% during cardiopulmonary arrest. Because of the resuscitation environment, errors in prescribing, doing, preparing, labeling and administering the drugs are prone to occur. A 2015 Institute of Medicine (IOM) Report entitled: "Strategies to Improve Cardiac Arrest Survival: A Time to Act", recommended translational research focusing on the function of resuscitation teams be undertaken to improve outcomes from CPA.

1) Goals, Objectives, and Project Outputs Goal To identify, describe and quantify patterns of inattentional blindness related to critical errors for resuscitation teams during the management of perioperative pediatric cardiac arrest.

Objectives

  1. To determine the frequency of CC-related errors that are undetected by resuscitation teams during management of a simulated pediatric cardiac arrest with average noise level (85 dBA) vs high noise (100 dBA) in the operating room during resuscitation.
  2. To determine the frequency of medication-related errors that are undetected by resuscitation teams during management of a simulated pediatric cardiac arrest with average noise level (85dBA) vs high noise (100 dBA) level in the operating room during resuscitation.
  3. To determine the frequency of "look but not act" events (for CC related errors/ medication) during the management of simulated perioperative cardiac arrest.
  4. To describe the underlying cause for "look but not act" events as it relates to CC related errors in management of simulated perioperative cardiac arrest.

Proposed Project Outputs

  1. The investigators hypothesize that CC and medication errors are frequently left undetected and uncorrected, and that the less noise distractions during resuscitation improves but does not eliminate this pattern of inattentional blindness in resuscitation teams during simulated perioperative pediatric cardiac arrest.
  2. They hypothesize that "look but not act" events are a frequent occurrence during simulated pediatric cardiac arrest, and that healthcare providers will have varying reasons that explain the occurrence of "look but not act" events.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Anesthesia (Staff, fellows, senior residents) OR nursing staff

Description

Inclusion Criteria:

  1. current PALS certification or PALS instructor
  2. attending physician or senior resident (year 3 or 4) or fellow in pediatric anesthesia.
  3. The other provider will be OR nurse with recent basic life support certification (past 1 year).

Exclusion Criteria:

  • participant refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control
team will work in OR with volume of 85 dB
Other: sound level volume
Noise level during cardiac arrest
intervention
team will work in OR with volume of 100 dB
Other: sound level volume
Noise level during cardiac arrest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of each error type detected by any participant member of the resuscitation team (ie. team leader, the OR nurse).
Time Frame: simulation time = 10 minutes
Detection is defined as one or more participant member of the resuscitation team either: (a) verbally stating and sharing nature of error with one or more team members (eg. "the CC rate seems slow"); and/or (b) verbally providing corrective feedback for the specific error (eg. "Please press faster to improve CC rate").
simulation time = 10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spent to detect the error
Time Frame: 30 seconds
time for the participant to detect international errors
30 seconds
Team lead fixation errors
Time Frame: 1 minute
Duration and number of visual fixations on pre-defined areas of interest (AOI) for each error type by team leader and team members, as measured by eye tracking devices
1 minute
Frequency of "look but not act"
Time Frame: 45 minutes
Frequency of "look but not act" events for each error type - the participant(s) looks at the AOI for the error, but does not act (as determined by video review)
45 minutes
Reasons for "look but not act
Time Frame: 45 minutes
Reasons for "look but not act" events will be captured during semi-structured interviews.
45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Express Collaborative

Investigators

  • Study Director: Adam Cheng, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

October 8, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB19-1549

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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