Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602817
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
I-gel Plus Supraglottic Airway Device for Surgical Procedures in Prone Position
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The I-gel Plus Supraglottic Airway Device for Elective Surgical Procedures in Prone Position
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 that has been evaluated in various studies with high success and low complication rates Feasibility of supraglottic airway devices SGA in patients undergoing surgery in prone position has been demonstrated in some pilot studies and case series however the evidence is still limited It is currently uncertain if the i-gel Plus facilitates appropriate ventilation in individuals undergoing elective surgery in prone position
The primary aim of this single-center non-inferior study is to assess the leak fraction of the i-gel Plus in patients undergoing surgery in prone position and to compare it with data from an existing prospective control cohort in patients undergoing surgery in supine position Secondary aims are to investigate the oropharyngeal seal pressure and other secondary outcome parameters and to compare them with the control cohort
The primary aim of this single-center non-inferior study is to assess the leak fraction of the i-gel Plus in patients undergoing surgery in prone position and to compare it with data from an existing prospective control cohort in patients undergoing surgery in supine position Secondary aims are to investigate the oropharyngeal seal pressure and other secondary outcome parameters and to compare them with the control cohort
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