An observational study in Maternal Death During Childbirth, sponsored by KidSIM Simulation Program. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by KidSIM Simulation Program · Observational
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:
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.
77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.
This study's planned enrollment of 120 is below the median of 180 across 19 observational studies indexed under Maternal Death.
Browse Maternal Death studies →KidSIM Simulation Program is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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Health care providers at L\&D floor : Anesthesia, OBGYN, Nurses
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Exclusion Criteria:
the first responders on L\&D floor including : anesthesia, nurses and OBGYN
Behavioral: maternal arrest simulation on L&D floor
AFE on L\&D
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.
oxygenation
Time frame: 10/ minutes
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.
chest compressions
Time frame: 100-120/minutes
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.
defibrillation
Time frame: minutes
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.
time to incision
Time frame: 5 minutes
Quality of CPR
Depth
Time frame: 15 mins
Quality of CPR
Rate
Time frame: 15 minutes
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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KidSIM Simulation Program