Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602830
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
I-gel Plus Supraglottic Airway Device for Elective Laparoscopic Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
I-gel Plus Supraglottic Airway Device for Elective Laparoscopic Surgery -a Prospective Observational Study-
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
i-gel Plus is a novel supraglottic airway device SGA Feasibility of second-generation SGAs in patients undergoing elective laparoscopic surgery has been demonstrated in various studies During laparoscopic surgery intrabdominal pressure is increased by capnoperitoneum and frequently minute ventilation has to be adopted to counteract hypercapnia and higher inspiratory peak pressures have to be expected It is uncertain however if the i-gel Plus facilitates appropriate ventilation with low leakage volumes in patients undergoing laparoscopic surgery
The primary aim of this single-center non-inferiority study is to assess the leak fraction of the i-gel Plus under conditions of capnoperitoneum with and without Trendelenburg position and to compare it with baseline conditions Secondary aims are to assess secondary outcome parameters during capnoperitoneum with and without Trendelenburg position and to compare them with baseline conditions
The primary aim of this single-center non-inferiority study is to assess the leak fraction of the i-gel Plus under conditions of capnoperitoneum with and without Trendelenburg position and to compare it with baseline conditions Secondary aims are to assess secondary outcome parameters during capnoperitoneum with and without Trendelenburg position and to compare them with baseline conditions
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?:
None