The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During and After Unexpe… (NCT06589661) | Clinical Trial Compass
CompletedNot Applicable
The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During and After Unexpected Cesarean Delivery Under General Anesthesia to Inform Anesthetic Practice
Canada15 participantsStarted 2024-10-28
Plain-language summary
This study aims to explore the patients' and providers' perspectives and inform future anesthetic practice for patients undergoing unexpected cesarean delivery (CD) under general anesthetic (GA). The consideration of patients' concerns, preferences, expectations, and suggestions may lead to enhanced patient satisfaction, compliance, and quality of care that future patients receive during unexpected CD under GA. The investigators will possibly be able to identify gaps in procedural performance that warrant further investigation during the second phase of this study which will contribute to improvement of overall patient care. During the third phase, educational material will be generated from patient insights and will be distributed to the Department of Anesthesia, Department of Obstetrics and Gynaecology, Labour and Delivery Nurses and team of Anesthesia Assistants and Respiratory Therapists.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* aged 18 years or older
* 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:
* Under 18 years of age
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient questionnaire
Timeframe: Following cesarean delivery, and prior to hospital discharge (at approximately 48 hours postpartum).
2
Patient interview
Timeframe: Following cesarean delivery, and prior to hospital discharge (at approximately 48 hours postpartum).
Trial details
NCT IDNCT06589661
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital