The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During and After Unexpected Cesarean Delivery Under General Anesthesia to Inform Anesthetic Practice
NCT ID: NCT06589661
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
15 participants
OBSERVATIONAL
2024-10-28
2025-07-31
Brief Summary
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Detailed Description
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A single-shot spinal anesthesia is the most common technique for CD due to its simplicity, quality of sensory blockade and reliability, as well as because of the safety for the fetus. Nevertheless, there are clinical situation where general anesthesia is necessary. General anesthesia care in obstetric scenarios remains a serious concern because of a high failed intubation rate, accidental awareness, increasing association with postpartum depression requiring hospitalization, suicidal ideation and self-inflicted injury, and traumatic birth experiences. General anesthesia for CD might not be planned and pivoting to this unexpected type of anesthesia can be a traumatic experience for patients and their families. Patients may receive a GA for various reasons, including failed neuraxial anesthesia, hemodynamic instability, or critical fetal situations not amendable to neuraxial anesthesia.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Unexpected cesarean delivery under general anesthesia
Patients who have an unexpected cesarean delivery under general anesthesia.
Interview
Patients will be interviewed by the research team to learn about their experience of Cesarean delivery under general anesthetic.
Interventions
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Interview
Patients will be interviewed by the research team to learn about their experience of Cesarean delivery under general anesthetic.
Eligibility Criteria
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Inclusion Criteria
* English language proficiency (as interviews will be performed in English)
* ASA Physical Classification Score 2-5 +/- E
* Emergency or Urgent Cesarean Delivery with the need for general anesthesia due to fetal or maternal emergencies (e.g., fetal bradycardia, HELLP syndrome, etc.)
* Unexpected Cesarean Delivery is defined as Level 1 (Emergency - Immediate threat to life of woman or fetus) and Level 2 (Urgent - Maternal or fetal compromise which is not immediately life-threatening) Cesarean Deliveries.21
* Patients will be included if they undergo preterm delivery (under 37 weeks of gestation, or are having a multiple gestation pregnancy, also, if there is a significant fetal anomaly present.
Exclusion Criteria
* Unable to answer questions due to a language barrier or because of their mental or physical state (e.g., intubated patients)
* BMI at the time of delivery that falls in the super-morbidly obese category (BMI \> 55 kg/m2)
* Patients who underwent preterm delivery (under 32 weeks gestation)
* Patients will be excluded if neonatal death has occurred.
* Patients who were scheduled for an elective Cesarean Delivery, but had contraindicated or failed neuraxial anesthesia and required general anesthesia for or during their CD will be excluded.
18 Years
50 Years
FEMALE
No
Sponsors
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Samuel Lunenfeld Research Institute, Mount Sinai Hospital
OTHER
Responsible Party
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Locations
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Mount Sinai Hospital
Toronto, Ontario, Canada
Countries
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Facility Contacts
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Other Identifiers
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24-07
Identifier Type: -
Identifier Source: org_study_id