Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589687
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
The Patient AS EDUcator in Anesthesia Exploring the Patients Experience During and After Unexpected Cesarean Delivery Under Neuraxial Anesthesia to Inform Anesthetic Practice
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Patient AS EDUcator in Anesthesia Exploring the Patients Experience During and After Unexpected Cesarean Delivery Under Neuraxial Anesthesia to Inform Anesthetic Practice A Prospective Patient-centred Multidisciplinary Mixed-method PAS-EDU-uCD-NA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAS-EDU-uCD-NA
Brief Summary:
This study aims to explore the patients and providers perspectives and inform future anesthetic practice for patients undergoing unexpected cesarean delivery CD under neuraxial anesthesia NA 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 NA 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
Detailed Description:
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 Neuraxial anesthesia NA is the preferred anesthetic for CD because it has a better safety profile avoids airway management decreases blood loss improves postoperative analgesia and decreases neonatal drug exposure compared with general anesthesia
NA allows the patient and partner to experience the delivery enhancing parent-baby bonding but has many well-described risks including hypotension leading to nausea shivering post-dural puncture headache nerve injury and failure to achieve satisfactory anesthesia If a CD is needed in a parturient with an existing labour epidural analgesia it is common practice to convert or top-up the epidural catheter with the aim of initiating surgical anesthesia by injecting more concentrated local anesthetic LA solution normally combined with a lipid-soluble opioid
Patients greatest concern during and after CD is pain Childbirth is a profound experience with 13 of patients experiencing a highly stressful and potentially traumatic childbirth A birthing parents experience during a planned CD versus an unexpected CD uCD can play a role in the development of post-traumatic stress disorder PTSD Childbirth-related PTSD is estimated to affect 5-6 of all postpartum women With CD representing 13 of all North American deliveries annually uCDs will contribute to an increased risk of PTSD and post-partum depression PPD symptoms Given the suffering associated with PPD and that women experiencing PPD incur greater health care costs understanding the association between CD and associated traumatic birth experiences may help guide interventions to address both the psychosocial impact on families and the economic impacts on health care
The concept of patients as educators is new to the practice of anesthesia and aims to embrace the patient perspective to guide quality improvement initiatives This study will explore patients perception of their experience with uCD under neuraxial anesthesia uCD-NA and aim to provide insight into patients feelings concerns and expectations after an unscheduled experience for childbirth By adding the providers perspective on the topic of childbirth via uCD-NA the investigators will be able to explore differences and similarities in opinions thoughts feelings and concerns as well as wishes for their care between patients and their providers Thus the study will also aim to explore the perspective of anesthesiologists anesthesia assistantsrespiratory therapists obstetricians and registered nurses
NA allows the patient and partner to experience the delivery enhancing parent-baby bonding but has many well-described risks including hypotension leading to nausea shivering post-dural puncture headache nerve injury and failure to achieve satisfactory anesthesia If a CD is needed in a parturient with an existing labour epidural analgesia it is common practice to convert or top-up the epidural catheter with the aim of initiating surgical anesthesia by injecting more concentrated local anesthetic LA solution normally combined with a lipid-soluble opioid
Patients greatest concern during and after CD is pain Childbirth is a profound experience with 13 of patients experiencing a highly stressful and potentially traumatic childbirth A birthing parents experience during a planned CD versus an unexpected CD uCD can play a role in the development of post-traumatic stress disorder PTSD Childbirth-related PTSD is estimated to affect 5-6 of all postpartum women With CD representing 13 of all North American deliveries annually uCDs will contribute to an increased risk of PTSD and post-partum depression PPD symptoms Given the suffering associated with PPD and that women experiencing PPD incur greater health care costs understanding the association between CD and associated traumatic birth experiences may help guide interventions to address both the psychosocial impact on families and the economic impacts on health care
The concept of patients as educators is new to the practice of anesthesia and aims to embrace the patient perspective to guide quality improvement initiatives This study will explore patients perception of their experience with uCD under neuraxial anesthesia uCD-NA and aim to provide insight into patients feelings concerns and expectations after an unscheduled experience for childbirth By adding the providers perspective on the topic of childbirth via uCD-NA the investigators will be able to explore differences and similarities in opinions thoughts feelings and concerns as well as wishes for their care between patients and their providers Thus the study will also aim to explore the perspective of anesthesiologists anesthesia assistantsrespiratory therapists obstetricians and registered nurses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None