NCT04122391

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

October 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

October 8, 2019

Last Update Submit

March 23, 2020

Conditions

Keywords

simulationcardiac arrestperioperative cardiac arrest

Outcome Measures

Primary Outcomes (1)

  • proportion of each error type detected by any participant member of the resuscitation team (ie. team leader, the OR nurse).

    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 Outcomes (4)

  • Time spent to detect the error

    30 seconds

  • Team lead fixation errors

    1 minute

  • Frequency of "look but not act"

    45 minutes

  • Reasons for "look but not act

    45 minutes

Study Arms (2)

control

team will work in OR with volume of 85 dB

Other: sound level volume

intervention

team will work in OR with volume of 100 dB

Other: sound level volume

Interventions

Noise level during cardiac arrest

controlintervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • participant refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 25226499BACKGROUND
  • 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.

    PMID: 26473000BACKGROUND
  • 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.

    PMID: 26472853BACKGROUND
  • 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.

    PMID: 23801105BACKGROUND
  • 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.

    PMID: 28358179BACKGROUND
  • 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.

    PMID: 24842846BACKGROUND
  • 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.

    PMID: 22623717BACKGROUND
  • 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.

    PMID: 25565457BACKGROUND
  • 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.

    PMID: 19733427BACKGROUND
  • 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.

    PMID: 23994802BACKGROUND
  • 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.

    PMID: 19581266BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Adam Cheng

    University of Calgary

    STUDY DIRECTOR

Central Study Contacts

Fatemah Qasem, MBBCh

CONTACT

Adam Cheng, MB FRCPC

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 10, 2019

Study Start

December 1, 2020

Primary Completion

March 1, 2021

Study Completion

June 1, 2021

Last Updated

March 25, 2020

Record last verified: 2020-03