Mount Sinai Hospital
Toronto, Ontario, M5G1X5, Canada
NCT Number: NCT06589661
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.
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Notify Me18 year–50 year
Female
Observational
Toronto, Ontario, M5G1X5, Canada
Cesarean delivery (CD) is a surgical procedure that allows for birth of a neonate through a laparotomy and hysterotomy and is the most common surgical procedure performed worldwide with 21% of all childbirths occurring via CD.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be interviewed by the research team to learn about their experience of Cesarean delivery under general anesthetic.
Time frame: Following cesarean delivery, and prior to hospital discharge (at approximately 48 hours postpartum).
Patients will be asked to rate their experience of having a cesarean delivery under general anesthesia, in terms of satisfaction and their experience with any discomfort. Some questions are yes/no, some are on a scale from 1-10, where 1 = not at all and 10 = totally agree, and some are open-ended. The questionnaire will take approximately 10 minutes to complete.
Time frame: Following cesarean delivery, and prior to hospital discharge (at approximately 48 hours postpartum).
Patients will be interviewed in person by a member of the research team and asked open ended questions. Interviews will be recorded, transcribed and coded for themes. Responses are not reported on any scale. The interview will take approximately 30 minutes to complete.
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Other
The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During and After Unexpected Cesarean Delivery Under General Anesthesia to Inform Anesthetic Practice. A Prospective Patient-centred Multidisciplinary Mixed-method. (PAS-EDU-uCD-GA)
Acronym: PAS-EDU-uCD-GA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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