Ignite Creation Date:
2025-12-18 @ 8:35 AM
Ignite Modification Date:
2025-12-23 @ 9:48 PM
Study NCT ID:
NCT05361512
Status:
None
Last Update Posted:
2023-02-23 00:00:00
First Post:
2022-04-29 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characteristics of the Tsui Test and Pressure Waveform to Confirm Epidural Catheter Placement in Parturients With BMI ≥50 kg/m2
Sponsor:
None
Organization:
Study Overview
Official Title:
Characteristics of the Tsui Test and Pressure Waveform to Confirm Epidural Catheter Placement in Parturients With BMI ≥50 kg/m2
Status:
None
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Tsui test has been well studied in obstetric patients, including required threshold electric currents and muscle contraction patterns. However, these studies have been conducted in patients receiving lumbar epidural catheters. Furthermore, they have not specifically included women with obesity class 3, particularly those with BMI≥50 kg/m2. In a recent study conducted in our department, the investigators have observed that patients with BMI≥50 kg/m2 require placement of an epidural catheter at a low-thoracic or high lumbar interspace, to allow the provision of effective surgical anesthesia for cesarean delivery, which often requires a modified incision, either transverse supra-umbilical or infra-umbilical. There are only few studies with waveform confirmation in obstetric patients showing conflicting results and certainly no studies under the circumstances described above. Finally, the Tsui test and the epidural waveform analysis have never been compared in the obstetric population.
Detailed Description:
None
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?: