Clinical trial NCT04050631: Critical Delays in Cardiopulmonary Resuscitation During Simulated Obstetric Crisis: a Prospective Observational Study.
Official title: In Hospital Maternal Cardiac Arrests: Highlighting the Importance of the First 5 Minutes.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Maternal Death During Childbirth
Lead sponsor: KidSIM Simulation Program
Sponsor class: NETWORK
First posted: 2019-08-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health care providers at L\&D floor : Anesthesia, OBGYN, Nurses

Brief summary: Maternal cardiac arrest is underreported and continues to occur at rate of 1:20,000 pregnancies. Despite being predominantly younger patients, survival rates among pregnant women are poor with one case series reporting a survival rate of 6.9%. Resuscitation of a pregnant women can be challenging when compared to non-pregnant adults. Aggressive maneuvers (perimortum cesarean section) and multidisciplinary team efforts are required because of the anatomical and physiological changes associated with pregnancy, in addition to taking care of two patents (mother and fetus). The first 5 minutes from the onset of cardiac arrest are the most crucial in terms of neonatal survival. In maternal deaths involving acute cardiac arrest, advanced cardiac life support (ACLS) must be rapidly administered. Previous work suggests deficits in cardiac arrest care during maternal cardiac arrest. The current literature fails to adequately quantify the severity, timing and frequency of errors made during maternal cardiac arrest care amongst interprofessional healthcare teams.

The primary goal of this study is to characterize the quality of actions by first responders during simulated in-hospital maternal medical emergencies. Specific objectives are:

1. to examine critical delays by measuring the median duration of the interval between when a resuscitation maneuver was indicated and when it was initiated by first responders ( nursing staff at L\&D attending the patient).
2. to describe the type and frequency of resuscitation errors identified as deviations from AHA guidelines during obstetric cardiac arrest. By addressing this gap in the literature, we hope to highlight areas of future education and/or innovation aimed at improving performance during maternal cardiac arrest care.

Detailed description: The investigators are planning to conduct a pilot descriptive study involving Foothill Medical Centre (FMC), Calgary. Research ethics approval will be obtained. The trial will also be registered at clinicaltrials.gov

The sessions will take place at the labor and delivery floor (L\&D) simulation lab at FMC. The proposed time for study completion is 18 months. No follow up is required for this study. The data will be collected by one of the investigators (Dr. Fatemah Qasem). In addition, the participants performance will be video recorded for further data collection and revision by the investigator team.

On the day of the simulation session, the participants will be pre-briefed to the simulation room, mannequin, and the equipment but will be naïve to the simulation scenario. The simulation scenario will involve amniotic fluid embolism (AFE) in a term pregnant parturient with singleton pregnancy. The patient will have a working epidural catheter in situ for labor analgesia and an 18G IV line. The parturient will develop cardiopulmonary collapse due to AFE requiring ACLS.

The scenario will be scripted by investigator team members. The same scenario will be used at both centers (FMC and RGH). The script will include the initial clinical vignette; vital signs; patient weight; laboratory values; planned changes in clinical status, including what and when decompensations should occur (eg, 4 minutes into scenario, the patient will progress to pulseless VT); and planned responses to actions by participants. Time 0 will be referred to the onset of the decompensation. For maintaining realism, little interaction will occur between participants and evaluators. If no one remembers to call the code team, then the emergency is managed with only L\&D staff. Although the primary focus of this study is to assess the quality of resuscitation delivered by first responders before the code team's arrival, the exercise will also allow to assess the resuscitation skills of obstetric care unit team. The scenario will end at skin incision for delivery of the fetus. Thirty minutes will be used for debriefing time as part of the hospital staff education. Data collected during the debriefing, and discussion points will used for quality improvement purposes and will not be used as part of the study results.

Eligibility criteria: Inclusion Criteria:

* Obstetric healthcare providers: including: nurses, nurse practitioners, respiratory therapists and residents (obstetric and anesthesia)
* Basic Life Support (BLS) or Advanced Cardiac Life Support (ACLS) certification within the past two years;

Exclusion Criteria:

* Not BLS certified.
* Participant refusal

Primary outcomes:
measure: The primary outcomes will be the median duration of the interval between when a resuscitation maneuver is indicated and when it will be initiated by first responders.
timeFrame: 10/ minutes
measure: The primary outcomes will be the median duration of the interval between when a resuscitation maneuver is indicated and when it will be initiated by first responders.
timeFrame: 100-120/minutes
measure: The primary outcomes will be the median duration of the interval between when a resuscitation maneuver is indicated and when it will be initiated by first responders.
timeFrame: minutes
measure: The primary outcomes will be the median duration of the interval between when a resuscitation maneuver is indicated and when it will be initiated by first responders.
timeFrame: 5 minutes
Secondary outcomes:
measure: Quality of CPR
timeFrame: 15 mins
measure: Quality of CPR
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
Study officials:
affiliation: University of Calgary
name: Adam Cheng
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campbell TA, Sanson TG. Cardiac arrest and pregnancy. J Emerg Trauma Shock. 2009 Jan;2(1):34-42. doi: 10.4103/0974-2700.43586.
citation: Dijkman A, Huisman CM, Smit M, Schutte JM, Zwart JJ, van Roosmalen JJ, Oepkes D. Cardiac arrest in pregnancy: increasing use of perimortem caesarean section due to emergency skills training? BJOG. 2010 Feb;117(3):282-7. doi: 10.1111/j.1471-0528.2009.02461.x.
citation: Yeomans ER, Gilstrap LC 3rd. Physiologic changes in pregnancy and their impact on critical care. Crit Care Med. 2005 Oct;33(10 Suppl):S256-8. doi: 10.1097/01.ccm.0000183540.69405.90.