- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04122391
Intentional Blindness During Perioperative Cardiac Arrest
Patterns of Inattentional Blindness During Perioperative Cardiac Arrest: Do Healthcare Providers See and Correct Critical Errors?
Study Overview
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
- 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.
- 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.
- To determine the frequency of "look but not act" events (for CC related errors/ medication) during the management of simulated perioperative cardiac arrest.
- 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
- 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 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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Fatemah Qasem, MBBCh
- Phone Number: (403)955-7211
- Email: fatemah.qasem@ucalgary.ca
Study Contact Backup
- Name: Adam Cheng, MB FRCPC
- Phone Number: (403)955-7211
- Email: Adam.cheng@ucalgary.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- current PALS certification or PALS instructor
- attending physician or senior resident (year 3 or 4) or fellow in pediatric anesthesia.
- The other provider will be OR nurse with recent basic life support certification (past 1 year).
Exclusion Criteria:
- participant refusal
Study Plan
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
|
Noise level during cardiac arrest
|
intervention
team will work in OR with volume of 100 dB
|
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
Sponsor
Investigators
- Study Director: Adam Cheng, University of Calgary
Publications and helpful links
General Publications
- Gonzalez LP, Braz JR, Modolo MP, de Carvalho LR, Modolo NS, Braz LG. Pediatric perioperative cardiac arrest and mortality: a study from a tertiary teaching hospital. Pediatr Crit Care Med. 2014 Nov;15(9):878-84. doi: 10.1097/PCC.0000000000000248.
- de Caen AR, Berg MD, Chameides L, Gooden CK, Hickey RW, Scott HF, Sutton RM, Tijssen JA, Topjian A, van der Jagt EW, Schexnayder SM, Samson RA. Part 12: Pediatric Advanced Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S526-42. doi: 10.1161/CIR.0000000000000266. No abstract available.
- de Caen AR, Maconochie IK, Aickin R, Atkins DL, Biarent D, Guerguerian AM, Kleinman ME, Kloeck DA, Meaney PA, Nadkarni VM, Ng KC, Nuthall G, Reis AG, Shimizu N, Tibballs J, Veliz Pintos R; Pediatric Basic Life Support and Pediatric Advanced Life Support Chapter Collaborators. Part 6: Pediatric Basic Life Support and Pediatric Advanced Life Support: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2015 Oct 20;132(16 Suppl 1):S177-203. doi: 10.1161/CIR.0000000000000275. No abstract available. Erratum In: Circulation. 2016 Aug 30;134(9):e121.
- Meaney PA, Bobrow BJ, Mancini ME, Christenson J, de Caen AR, Bhanji F, Abella BS, Kleinman ME, Edelson DP, Berg RA, Aufderheide TP, Menon V, Leary M; CPR Quality Summit Investigators, the American Heart Association Emergency Cardiovascular Care Committee, and the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation. Cardiopulmonary resuscitation quality: [corrected] improving cardiac resuscitation outcomes both inside and outside the hospital: a consensus statement from the American Heart Association. Circulation. 2013 Jul 23;128(4):417-35. doi: 10.1161/CIR.0b013e31829d8654. Epub 2013 Jun 25. Erratum In: Circulation. 2013 Aug 20;128(8):e120. Circulation. 2013 Nov 12;128(20):e408.
- Hinkelbein J, Andres J, Thies KC, DE Robertis E. Perioperative cardiac arrest in the operating room environment: a review of the literature. Minerva Anestesiol. 2017 Nov;83(11):1190-1198. doi: 10.23736/S0375-9393.17.11802-X. Epub 2017 Mar 28.
- Sutton RM, French B, Niles DE, Donoghue A, Topjian AA, Nishisaki A, Leffelman J, Wolfe H, Berg RA, Nadkarni VM, Meaney PA. 2010 American Heart Association recommended compression depths during pediatric in-hospital resuscitations are associated with survival. Resuscitation. 2014 Sep;85(9):1179-84. doi: 10.1016/j.resuscitation.2014.05.007. Epub 2014 May 16.
- Idris AH, Guffey D, Aufderheide TP, Brown S, Morrison LJ, Nichols P, Powell J, Daya M, Bigham BL, Atkins DL, Berg R, Davis D, Stiell I, Sopko G, Nichol G; Resuscitation Outcomes Consortium (ROC) Investigators. Relationship between chest compression rates and outcomes from cardiac arrest. Circulation. 2012 Jun 19;125(24):3004-12. doi: 10.1161/CIRCULATIONAHA.111.059535. Epub 2012 May 23.
- Idris AH, Guffey D, Pepe PE, Brown SP, Brooks SC, Callaway CW, Christenson J, Davis DP, Daya MR, Gray R, Kudenchuk PJ, Larsen J, Lin S, Menegazzi JJ, Sheehan K, Sopko G, Stiell I, Nichol G, Aufderheide TP; Resuscitation Outcomes Consortium Investigators. Chest compression rates and survival following out-of-hospital cardiac arrest. Crit Care Med. 2015 Apr;43(4):840-8. doi: 10.1097/CCM.0000000000000824.
- Sutton RM, Maltese MR, Niles D, French B, Nishisaki A, Arbogast KB, Donoghue A, Berg RA, Helfaer MA, Nadkarni V. Quantitative analysis of chest compression interruptions during in-hospital resuscitation of older children and adolescents. Resuscitation. 2009 Nov;80(11):1259-63. doi: 10.1016/j.resuscitation.2009.08.009. Epub 2009 Sep 4.
- Sutton RM, Niles D, French B, Maltese MR, Leffelman J, Eilevstjonn J, Wolfe H, Nishisaki A, Meaney PA, Berg RA, Nadkarni VM. First quantitative analysis of cardiopulmonary resuscitation quality during in-hospital cardiac arrests of young children. Resuscitation. 2014 Jan;85(1):70-4. doi: 10.1016/j.resuscitation.2013.08.014. Epub 2013 Aug 29.
- Sutton RM, Niles D, Nysaether J, Abella BS, Arbogast KB, Nishisaki A, Maltese MR, Donoghue A, Bishnoi R, Helfaer MA, Myklebust H, Nadkarni V. Quantitative analysis of CPR quality during in-hospital resuscitation of older children and adolescents. Pediatrics. 2009 Aug;124(2):494-9. doi: 10.1542/peds.2008-1930. Epub 2009 Jul 5.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- REB19-1549
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
product manufactured in and exported from the U.S.
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