Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578598
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Comparison of Gastric Insufflation With the Classic Igel Laryngeal Mask and the New Igelplus Laryngeal Mask Using Gastric Ultrasound
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Gastric Air Insufflation and Ventilation Between Two Laryngeals Masks LMA Igel and Igelplus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
This study aims to compare the effectiveness and safety of two types of laryngeal masks- iGel and iGel Plus used during elective surgeries The focus is on evaluating differences in gastric insufflation and ventilation parameters between these two devices Participants will be patients classified as ASA 1-2 with a BMI of less than 35 undergoing elective procedures
The study is designed as a prospective randomized controlled trial with 200 subjects divided evenly between the two laryngeal mask groups Key outcomes include gastric cross-sectional area CSA measurements before and after surgery ventilation metrics such as leakage pressure and PEEP and the incidence of postoperative complications like nausea and respiratory issues
The study is designed as a prospective randomized controlled trial with 200 subjects divided evenly between the two laryngeal mask groups Key outcomes include gastric cross-sectional area CSA measurements before and after surgery ventilation metrics such as leakage pressure and PEEP and the incidence of postoperative complications like nausea and respiratory issues
Detailed Description:
A Comparative Study of Gastric Insufflation and Ventilation Parameters Between iGel and iGel Plus Laryngeal Masks in Elective Outpatient Surgeries
Laryngeal masks LM are commonly used in airway management during elective surgeries as they offer a less invasive alternative to endotracheal intubation providing effective ventilation while reducing the risk of trauma to the airway Among the available options the iGel laryngeal mask and its advanced version the iGel Plus have gained popularity The iGel mask is known for its unique non-inflatable cuff that conforms to the patients anatomy providing a secure fit and minimizing the risk of airway complications The iGel Plus is an enhanced version designed to improve anatomical fit reduce the incidence of leaks and potentially decrease the risk of gastric insufflation
The purpose of this study is to investigate the differences in gastric insufflation and ventilation parameters when using the iGel versus the iGel Plus laryngeal mask during elective surgical procedures Given the potential benefits of the iGel Plus in optimizing airway management and reducing postoperative complications this study aims to provide clinical evidence to guide the selection of laryngeal masks in practice
The primary objective is to compare the incidence and extent of gastric insufflation between the iGel and iGel Plus laryngeal masks Secondary we want to assess and compare ventilation parameters including leakage pressure inspiratory pressure Pinsp positive end-expiratory pressure PEEP and the number of insertion attempts required for effective mask placement Additionally the study will evaluate the incidence of postoperative complications such as nausea sore throat and respiratory complications SpO2 92
Laryngeal masks LM are commonly used in airway management during elective surgeries as they offer a less invasive alternative to endotracheal intubation providing effective ventilation while reducing the risk of trauma to the airway Among the available options the iGel laryngeal mask and its advanced version the iGel Plus have gained popularity The iGel mask is known for its unique non-inflatable cuff that conforms to the patients anatomy providing a secure fit and minimizing the risk of airway complications The iGel Plus is an enhanced version designed to improve anatomical fit reduce the incidence of leaks and potentially decrease the risk of gastric insufflation
The purpose of this study is to investigate the differences in gastric insufflation and ventilation parameters when using the iGel versus the iGel Plus laryngeal mask during elective surgical procedures Given the potential benefits of the iGel Plus in optimizing airway management and reducing postoperative complications this study aims to provide clinical evidence to guide the selection of laryngeal masks in practice
The primary objective is to compare the incidence and extent of gastric insufflation between the iGel and iGel Plus laryngeal masks Secondary we want to assess and compare ventilation parameters including leakage pressure inspiratory pressure Pinsp positive end-expiratory pressure PEEP and the number of insertion attempts required for effective mask placement Additionally the study will evaluate the incidence of postoperative complications such as nausea sore throat and respiratory complications SpO2 92
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